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Trial record 25 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)

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ClinicalTrials.gov Identifier: NCT01170962
Recruitment Status : Completed
First Posted : July 28, 2010
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Drug: BMS-790052
Drug: Placebo
Drug: peginterferon alfa-2a
Drug: ribavirin
Enrollment 512
Recruitment Details Participants were enrolled at 69 sites in 11 countries.
Pre-assignment Details A total of 512 participants were enrolled and 421 participants were randomized (2 randomized participants were not treated: 1 due to positive pregnancy test and 1 no longer met criteria). Remaining 91 participants were not randomized as; 73 no longer met study criteria, 15 withdrew consent, 1 due to administrative reason and 2 for other reasons.
Arm/Group Title Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Partial Responders
Hide Arm/Group Description Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Period Title: Treatment Period
Started 203 199 17
No PDR 145 127 17
PDR ­Randomized to 24 Weeks pegIFNα­-2a 30 36 0
PDR ­Randomized to 48 Weeks Follow­-up 28 36 0
Completed 76 88 5
Not Completed 127 111 12
Reason Not Completed
Lack of Efficacy             96             91             7
Adverse Event             11             12             3
Withdrawal by Subject             2             1             0
Lost to Follow-up             1             1             1
Participant no longer meets criteria             0             1             0
Request to discontinue treatment             7             3             1
Completed 24 Week treatment period only             10             2             0
Period Title: Follow up Period
Started 198 [1] 192 [2] 15 [3]
Completed 159 165 9
Not Completed 39 27 6
Reason Not Completed
Withdrawal by Subject             14             10             2
Lost to Follow-up             13             8             1
Death             2             2             0
Others             10             7             3
[1]
Out of 203 participants who entered the treatment period, 198 continued in the follow-up period.
[2]
Out of 199 participants who entered the treatment period, 192 continued in the follow-up period.
[3]
Out of 17 participants who entered the treatment period, 15 continued in the follow-up period.
Arm/Group Title Daclastavir (20mg): Prior Null and Partial Responders Daclastavir (60mg): Prior Null and Partial Responders Placebo: Prior Partial Responders Total
Hide Arm/Group Description Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Total of all reporting groups
Overall Number of Baseline Participants 203 199 17 419
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 203 participants 199 participants 17 participants 419 participants
21-65 years 192 189 15 396
>=65 years 11 10 2 23
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 199 participants 17 participants 419 participants
Female
70
  34.5%
72
  36.2%
4
  23.5%
146
  34.8%
Male
133
  65.5%
127
  63.8%
13
  76.5%
273
  65.2%
1.Primary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame Week 4, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 133 132 70 67 17
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
18.0
(13.8 to 22.3)
19.7
(15.3 to 24.1)
25.7
(19.0 to 32.4)
35.8
(28.3 to 43.3)
0
(0.0 to 0.0)
2.Primary Outcome
Title Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
Hide Description SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame Follow-up Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 133 132 70 67 17
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
18.8
(14.5 to 23.1)
22.0
(17.4 to 26.6)
24.3
(17.7 to 30.9)
43.3
(35.5 to 51.0)
0
(0.0 to 0.0)
3.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame From first dose to last dose plus 7 days, up to 49 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants.
Arm/Group Title Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 203 199 17
Measure Type: Number
Unit of Measure: participants
SAEs 14 11 3
AEs Leading to Discontinuation of Treatment 11 12 3
Death 0 0 1
4.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame From day 8 post last dose of treatment up-to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants.
Arm/Group Title Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 198 192 15
Measure Type: Number
Unit of Measure: participants
SAEs 6 7 0
Death 2 2 0
5.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR)
Hide Description RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily up to 24 weeks. Participants continued to receive pegIFNα-2a and ribavirin, up to 48 weeks followed by a post treatment follow-up period of 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 133 132 70 67 17
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
21.8
(17.2 to 26.4)
21.2
(16.7 to 25.8)
25.7
(19.0 to 32.4)
38.8
(31.2 to 46.4)
0
(0.0 to 0.0)
6.Secondary Outcome
Title Percentage of Participants With Complete Early Virologic Response (cEVR)
Hide Description cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 133 132 70 67 17
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
30.1
(25.0 to 35.2)
34.1
(28.8 to 39.4)
44.3
(36.7 to 51.9)
56.7
(49.0 to 64.5)
0
(0.0 to 0.0)
7.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Hide Description SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 133 132 70 67 17
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
19.5
(15.1 to 24.0)
23.5
(18.8 to 28.2)
25.7
(19.0 to 32.4)
47.8
(39.9 to 55.6)
0
(0.0 to 0.0)
8.Secondary Outcome
Title Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Hide Description Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Time Frame Baseline to follow-up Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy.
Overall Number of Participants Analyzed 83 86 50 37
Measure Type: Number
Unit of Measure: participants
M28: L/T/V: Baseline (n=78,84,49,36) 2 3 1 3
M28: L/T/V: On-Treatment (n= 60,57,34,22) 2 3 1 2
M28: L/T/V: Relapsers (n=10,12,7,3) 0 0 0 0
Q30: H: Baseline (n=78,0,0,36) 1 NA [1]  NA [1]  1
Q30: H: On-Treatment (n= 60,0,0,22) 1 NA [1]  NA [1]  0
Q30: H:Relapsers (n=10,0,0,3) 0 NA [1]  NA [1]  0
L31: M: Baseline (n=78,84,49,36) 5 1 1 2
L31: M: On-Treatment (n= 60,57,34,22) 5 1 0 2
L31: M: Relapsers (n=10,12,7,3) 0 0 1 0
H54: Y: Baseline (n=0,84,49,0) NA [1]  2 1 NA [1] 
H54: Y: On-Treatment (n=0,57,34,0) NA [1]  2 1 NA [1] 
H54: Y: Relapsers (n=0,12,7,0) NA [1]  0 0 NA [1] 
H58: C/D/N/P/Q: Baseline (n=78,84,49,0) 4 3 3 NA [1] 
H58: C/D/N/P/Q: On-Treatment (n= 60,57,34,0) 4 3 1 NA [1] 
H58: C/D/N/P/Q: Relapsers (n=10,12,7,3) 0 0 0 NA [1] 
E62: D: Baseline (n=78,84,49,0) 1 3 2 NA [1] 
E62: D: On-Treatment (n= 60,57,34,0) 1 2 1 NA [1] 
E62: D: Relapsers (n=10,12,7,0) 0 1 0 NA [1] 
Y93: C: Baseline (n=0,84,49,0) NA [1]  1 1 NA [1] 
Y93: C: On-Treatment (n= 0,57,34,0) NA [1]  1 0 NA [1] 
Y93: C: Relapsers (n=0,12,7,0) NA [1]  0 1 NA [1] 
[1]
Data was not analyzed as no participant was evaluable at the specified time-point.
9.Secondary Outcome
Title Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Hide Description Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
Time Frame Baseline to follow-up Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Arm/Group Title Daclatasvir (20 mg): Prior Null Responders Daclatasvir (60 mg): Prior Null Responders Daclatasvir (20 mg): Prior Partial Responders Daclatasvir (60 mg): Prior Partial Responders
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
Overall Number of Participants Analyzed 44 38 20 29
Measure Type: Number
Unit of Measure: participants
L28: M/V: Baseline (n=43,37,19,0) 1 1 1 NA [1] 
L28: M/V: On-Treatment (n=19,20,6,0) 1 1 0 NA [1] 
L28: M/V: Relapsers (n=7,6,2,0) 0 0 0 NA [1] 
R30: H/Q: Baseline (n=43,37,19,27) 4 5 1 1
R30: H/Q: On-Treatment (n=19,20,6,5) 4 3 0 0
R30: H/Q: Relapsers (n=7,6,2,9) 0 2 1 1
L31: M: Baseline (n=43,37,19,27) 4 5 1 1
L31: M: On-Treatment (n=19,20,6,5) 2 4 0 0
L31: M: Relapsers (n=7,6,2,9) 1 0 1 1
Q54: H/N/Y: Baseline (n=43,37,19,27) 18 20 9 8
Q54: H/N/Y: On-Treatment (n=19,20,6,5) 9 12 5 2
Q54: H/N/Y: Relapsers (n=7,6,2,9) 5 1 0 2
P58: A/Q/S: Baseline (n=43,37,19,27) 3 7 2 3
P58: A/Q/S: On-Treatment (n=19,20,6,5) 2 3 1 0
P58: A/Q/S: Relapsers (n=7,6,2,9) 0 2 0 1
Q62: E/K/N/R/S: Baseline (n=43,37,19,27) 5 1 2 1
Q62: E/K/N/R/S: On-Treatment (n=19,20,6,5) 3 1 1 0
Q62: E/K/N/R/S: Relapsers (n=7,6,2,9) 0 0 0 1
A92: T/V: Baseline (n=43,37,19,0) 2 3 3 NA [1] 
A92: T/V: On-Treatment (n=0,20,6,0) NA [1]  2 1 NA [1] 
A92: T/V: Relapsers (n=0,6,2,0) NA [1]  0 0 NA [1] 
Y93: F/H: Baseline (n=43,37,0,27) 1 5 NA [1]  3
Y93: F/H: On-Treatment (n=0,20,0,5) NA [1]  4 NA [1]  0
Y93: F/H: Relapsers (n=0,6,0,9) NA [1]  1 NA [1]  2
[1]
Data was not analyzed as no participant was evaluable at the specified time-point.
Time Frame From first dose to last dose plus 7 days, up to 49 weeks
Adverse Event Reporting Description On-Treatment Period
 
Arm/Group Title Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Prior Partial Responders
Hide Arm/Group Description Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued. Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
All-Cause Mortality
Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Prior Partial Responders
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Prior Partial Responders
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   14/203 (6.90%)   11/199 (5.53%)   3/17 (17.65%) 
Blood and lymphatic system disorders       
Anaemia  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Anaemia haemolytic autoimmune  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Pancytopenia  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Cardiac disorders       
Angina unstable  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Eye disorders       
Retinal exudates  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Retinal haemorrhage  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal inflammation  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Duodenal ulcer  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Pancreatitis  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Anal fissure  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
General disorders       
Influenza like illness  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Pyrexia  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Hepatobiliary disorders       
Portal vein thrombosis  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Hepatic failure  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Infections and infestations       
Gastroenteritis  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Pneumonia  1  1/203 (0.49%)  1/199 (0.50%)  0/17 (0.00%) 
Cat scratch disease  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Lung infection  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Postoperative wound infection  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Staphylococcal sepsis  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Injury, poisoning and procedural complications       
Laceration  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Rib fracture  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Investigations       
Streptococcus test positive  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Metabolism and nutrition disorders       
Metabolic acidosis  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders       
Muscular weakness  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bone neoplasm  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Ovarian neoplasm  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Hepatic neoplasm malignant  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Lung neoplasm  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Nervous system disorders       
Ischaemic stroke  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Lacunar infarction  1  0/203 (0.00%)  1/199 (0.50%)  0/17 (0.00%) 
Hepatic encephalopathy  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Cerebrovascular accident  1  2/203 (0.99%)  0/199 (0.00%)  0/17 (0.00%) 
Psychiatric disorders       
Substance abuse  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Renal and urinary disorders       
Bladder perforation  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Renal failure acute  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Haemoptysis  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  1/203 (0.49%)  0/199 (0.00%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir (20 mg): Prior Null and Partial Responders Daclatasvir (60 mg): Prior Null and Partial Responders Placebo: Prior Partial Responders
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   190/203 (93.60%)   195/199 (97.99%)   15/17 (88.24%) 
Blood and lymphatic system disorders       
Anaemia  1  43/203 (21.18%)  28/199 (14.07%)  4/17 (23.53%) 
Thrombocytopenia  1  9/203 (4.43%)  10/199 (5.03%)  2/17 (11.76%) 
Neutropenia  1  31/203 (15.27%)  31/199 (15.58%)  4/17 (23.53%) 
Leukopenia  1  9/203 (4.43%)  2/199 (1.01%)  2/17 (11.76%) 
Cardiac disorders       
Palpitations  1  3/203 (1.48%)  2/199 (1.01%)  1/17 (5.88%) 
Tachycardia  1  6/203 (2.96%)  1/199 (0.50%)  1/17 (5.88%) 
Ear and labyrinth disorders       
Vertigo  1  10/203 (4.93%)  11/199 (5.53%)  0/17 (0.00%) 
Eye disorders       
Photophobia  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Blepharitis  1  1/203 (0.49%)  1/199 (0.50%)  1/17 (5.88%) 
Ocular hyperaemia  1  2/203 (0.99%)  0/199 (0.00%)  1/17 (5.88%) 
Eyelid disorder  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Cataract  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Lacrimation increased  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Gastrointestinal disorders       
Vomiting  1  19/203 (9.36%)  16/199 (8.04%)  2/17 (11.76%) 
Abdominal pain  1  13/203 (6.40%)  14/199 (7.04%)  2/17 (11.76%) 
Anorectal discomfort  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Nausea  1  55/203 (27.09%)  45/199 (22.61%)  3/17 (17.65%) 
Abdominal pain upper  1  19/203 (9.36%)  12/199 (6.03%)  3/17 (17.65%) 
Diarrhoea haemorrhagic  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Dyspepsia  1  13/203 (6.40%)  6/199 (3.02%)  1/17 (5.88%) 
Constipation  1  11/203 (5.42%)  5/199 (2.51%)  1/17 (5.88%) 
Dry mouth  1  9/203 (4.43%)  14/199 (7.04%)  2/17 (11.76%) 
Cheilitis  1  5/203 (2.46%)  3/199 (1.51%)  1/17 (5.88%) 
Diarrhoea  1  26/203 (12.81%)  32/199 (16.08%)  5/17 (29.41%) 
Gastrooesophageal reflux disease  1  13/203 (6.40%)  5/199 (2.51%)  0/17 (0.00%) 
Odynophagia  1  1/203 (0.49%)  0/199 (0.00%)  1/17 (5.88%) 
Gastritis  1  4/203 (1.97%)  3/199 (1.51%)  1/17 (5.88%) 
Haemorrhoidal haemorrhage  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Haemorrhoids  1  5/203 (2.46%)  6/199 (3.02%)  1/17 (5.88%) 
General disorders       
Asthenia  1  55/203 (27.09%)  38/199 (19.10%)  1/17 (5.88%) 
Injection site erythema  1  15/203 (7.39%)  14/199 (7.04%)  0/17 (0.00%) 
Injection site haematoma  1  0/203 (0.00%)  3/199 (1.51%)  1/17 (5.88%) 
Pain  1  9/203 (4.43%)  9/199 (4.52%)  1/17 (5.88%) 
Feeling abnormal  1  3/203 (1.48%)  1/199 (0.50%)  1/17 (5.88%) 
Oedema peripheral  1  2/203 (0.99%)  5/199 (2.51%)  2/17 (11.76%) 
Chills  1  16/203 (7.88%)  27/199 (13.57%)  4/17 (23.53%) 
Feeling hot  1  1/203 (0.49%)  0/199 (0.00%)  1/17 (5.88%) 
Influenza like illness  1  55/203 (27.09%)  59/199 (29.65%)  1/17 (5.88%) 
Mucosal dryness  1  3/203 (1.48%)  2/199 (1.01%)  1/17 (5.88%) 
Crying  1  1/203 (0.49%)  0/199 (0.00%)  1/17 (5.88%) 
Irritability  1  29/203 (14.29%)  42/199 (21.11%)  3/17 (17.65%) 
Fatigue  1  81/203 (39.90%)  91/199 (45.73%)  10/17 (58.82%) 
Injection site rash  1  3/203 (1.48%)  0/199 (0.00%)  1/17 (5.88%) 
Pyrexia  1  19/203 (9.36%)  23/199 (11.56%)  3/17 (17.65%) 
Infections and infestations       
Gingival abscess  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Nasopharyngitis  1  7/203 (3.45%)  10/199 (5.03%)  1/17 (5.88%) 
Rhinitis  1  1/203 (0.49%)  3/199 (1.51%)  1/17 (5.88%) 
Pharyngitis  1  3/203 (1.48%)  2/199 (1.01%)  1/17 (5.88%) 
Urinary tract infection  1  9/203 (4.43%)  5/199 (2.51%)  1/17 (5.88%) 
Bronchitis  1  11/203 (5.42%)  4/199 (2.01%)  0/17 (0.00%) 
Upper respiratory tract infection  1  5/203 (2.46%)  4/199 (2.01%)  2/17 (11.76%) 
Injury, poisoning and procedural complications       
Muscle rupture  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Joint injury  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Investigations       
Blood bilirubin increased  1  1/203 (0.49%)  0/199 (0.00%)  1/17 (5.88%) 
Alanine aminotransferase increased  1  2/203 (0.99%)  0/199 (0.00%)  1/17 (5.88%) 
Weight decreased  1  13/203 (6.40%)  6/199 (3.02%)  2/17 (11.76%) 
Electrocardiogram QT prolonged  1  0/203 (0.00%)  1/199 (0.50%)  1/17 (5.88%) 
Metabolism and nutrition disorders       
Decreased appetite  1  38/203 (18.72%)  36/199 (18.09%)  4/17 (23.53%) 
Hypoglycaemia  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  28/203 (13.79%)  31/199 (15.58%)  2/17 (11.76%) 
Myalgia  1  40/203 (19.70%)  33/199 (16.58%)  4/17 (23.53%) 
Back pain  1  16/203 (7.88%)  14/199 (7.04%)  0/17 (0.00%) 
Pain in extremity  1  9/203 (4.43%)  7/199 (3.52%)  1/17 (5.88%) 
Muscle spasms  1  13/203 (6.40%)  19/199 (9.55%)  2/17 (11.76%) 
Nervous system disorders       
Depressed level of consciousness  1  1/203 (0.49%)  0/199 (0.00%)  1/17 (5.88%) 
Memory impairment  1  8/203 (3.94%)  5/199 (2.51%)  1/17 (5.88%) 
Amnesia  1  4/203 (1.97%)  3/199 (1.51%)  1/17 (5.88%) 
Dizziness  1  22/203 (10.84%)  11/199 (5.53%)  0/17 (0.00%) 
Hepatic encephalopathy  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Disturbance in attention  1  7/203 (3.45%)  10/199 (5.03%)  2/17 (11.76%) 
Hypoaesthesia  1  6/203 (2.96%)  4/199 (2.01%)  1/17 (5.88%) 
Dysgeusia  1  10/203 (4.93%)  12/199 (6.03%)  1/17 (5.88%) 
Headache  1  71/203 (34.98%)  63/199 (31.66%)  7/17 (41.18%) 
Psychiatric disorders       
Anxiety  1  13/203 (6.40%)  16/199 (8.04%)  1/17 (5.88%) 
Sleep disorder  1  12/203 (5.91%)  12/199 (6.03%)  0/17 (0.00%) 
Emotional disorder  1  1/203 (0.49%)  1/199 (0.50%)  1/17 (5.88%) 
Insomnia  1  53/203 (26.11%)  53/199 (26.63%)  5/17 (29.41%) 
Affect lability  1  4/203 (1.97%)  2/199 (1.01%)  1/17 (5.88%) 
Depressed mood  1  4/203 (1.97%)  1/199 (0.50%)  1/17 (5.88%) 
Depression  1  25/203 (12.32%)  23/199 (11.56%)  3/17 (17.65%) 
Drug dependence  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders       
Pollakiuria  1  5/203 (2.46%)  5/199 (2.51%)  1/17 (5.88%) 
Reproductive system and breast disorders       
Erectile dysfunction  1  2/203 (0.99%)  0/199 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  35/203 (17.24%)  47/199 (23.62%)  3/17 (17.65%) 
Epistaxis  1  15/203 (7.39%)  7/199 (3.52%)  3/17 (17.65%) 
Productive cough  1  6/203 (2.96%)  7/199 (3.52%)  1/17 (5.88%) 
Dry throat  1  2/203 (0.99%)  2/199 (1.01%)  1/17 (5.88%) 
Respiratory tract congestion  1  5/203 (2.46%)  1/199 (0.50%)  1/17 (5.88%) 
Dyspnoea  1  46/203 (22.66%)  39/199 (19.60%)  4/17 (23.53%) 
Dyspnoea exertional  1  11/203 (5.42%)  10/199 (5.03%)  0/17 (0.00%) 
Oropharyngeal pain  1  9/203 (4.43%)  12/199 (6.03%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders       
Eczema  1  7/203 (3.45%)  10/199 (5.03%)  1/17 (5.88%) 
Rash  1  38/203 (18.72%)  38/199 (19.10%)  1/17 (5.88%) 
Rash erythematous  1  1/203 (0.49%)  1/199 (0.50%)  1/17 (5.88%) 
Rash papular  1  4/203 (1.97%)  2/199 (1.01%)  1/17 (5.88%) 
Photosensitivity reaction  1  2/203 (0.99%)  1/199 (0.50%)  1/17 (5.88%) 
Dermatitis bullous  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Dry skin  1  39/203 (19.21%)  65/199 (32.66%)  4/17 (23.53%) 
Ecchymosis  1  0/203 (0.00%)  0/199 (0.00%)  1/17 (5.88%) 
Alopecia  1  36/203 (17.73%)  42/199 (21.11%)  1/17 (5.88%) 
Erythema  1  8/203 (3.94%)  15/199 (7.54%)  2/17 (11.76%) 
Pruritus  1  55/203 (27.09%)  63/199 (31.66%)  3/17 (17.65%) 
Hyperhidrosis  1  0/203 (0.00%)  2/199 (1.01%)  1/17 (5.88%) 
Vascular disorders       
Hypotension  1  3/203 (1.48%)  1/199 (0.50%)  1/17 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01170962     History of Changes
Other Study ID Numbers: AI444-011
2010-019378-34 ( EudraCT Number )
First Submitted: July 16, 2010
First Posted: July 28, 2010
Results First Submitted: August 10, 2015
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015