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Trial record 24 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients (HEPCAT)

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ClinicalTrials.gov Identifier: NCT01125189
Recruitment Status : Completed
First Posted : May 18, 2010
Results First Posted : October 23, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C Virus
Interventions Drug: Daclatasvir
Drug: Placebo
Drug: peg-interferon alfa-2a
Drug: ribavirin
Enrollment 558
Recruitment Details Participants were enrolled at 64 sites in 11 countries.
Pre-assignment Details A total of 558 participants were enrolled in this study, and 395 participants were randomized and treated.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Period Title: Treatment Period
Started 159 158 78
Completed 128 123 37
Not Completed 31 35 41
Reason Not Completed
Lack of Efficacy             15             18             25
Adverse Event             7             8             8
Withdrawal by Subject             3             1             1
Death             1             0             0
Lost to Follow-up             1             2             1
Poor compliance/noncompliance             0             1             0
Participants requested to discontinue             1             3             4
Other reasons             1             1             0
Completed 24 week treatment period only             2             1             2
Period Title: Follow up Period
Started 152 [1] 153 [1] 74 [1]
Completed 132 138 58
Not Completed 20 15 16
Reason Not Completed
Withdrawal by Subject             3             2             5
Death             1             0             0
Lost to Follow-up             12             9             6
Other reasons             4             4             5
[1]
All participants who received treatment continued in the follow-up phase.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin Total
Hide Arm/Group Description Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol. Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 159 158 78 395
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 78 participants 395 participants
<65 years 154 154 77 385
≥65 years 5 4 1 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 78 participants 395 participants
Female
52
  32.7%
55
  34.8%
23
  29.5%
130
  32.9%
Male
107
  67.3%
103
  65.2%
55
  70.5%
265
  67.1%
Hepatitis C Virus RNA Distribution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 78 participants 395 participants
<800,000 IU/mL 26 35 17 78
≥800,000 IU/mL 133 123 61 317
IL-28B Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 159 participants 158 participants 78 participants 395 participants
CC genotype 53 44 23 120
CT genotype 82 86 38 206
TT genotype 17 18 11 46
Missing 7 10 6 23
1.Primary Outcome
Title Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
Hide Description eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
Time Frame Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, 'number of participants' analyzed (N) signifies number of participants evaluable for this outcome measure.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 147 146 72
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
54.4
(49.2 to 59.7)
54.1
(48.8 to 59.4)
13.9
(8.7 to 19.1)
2.Primary Outcome
Title Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
Hide Description SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, 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. Here, N signifies number of participants evaluable for this outcome measure.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 147 146 72
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
59.2
(54.0 to 64.4)
59.6
(54.4 to 64.8)
37.5
(30.2 to 44.8)
3.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
Hide Description SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame From start of study treatment (day 1) up to follow-up Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 159 158 78
Measure Type: Number
Unit of Measure: participants
SAEs 12 13 6
Discontinuations Due to AEs 7 7 8
Death 2 0 0
4.Secondary Outcome
Title Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
Hide Description RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, N signifies number of participants evaluable for this outcome measure.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 147 146 72
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
59.9
(54.7 to 65.0)
56.8
(51.6 to 62.1)
15.3
(9.8 to 20.7)
5.Secondary Outcome
Title Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
Hide Description cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, N signifies number of participants evaluable for this outcome measure.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 147 146 72
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
77.6
(73.1 to 82.0)
75.3
(70.8 to 79.9)
43.1
(35.6 to 50.5)
6.Secondary Outcome
Title Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
Hide Description SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, N signifies number of participants evaluable for this outcome measure.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 147 146 72
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
64.6
(59.6 to 69.7)
60.3
(55.1 to 65.5)
36.1
(28.9 to 43.4)
7.Secondary Outcome
Title Percentage of Resistant Variants Associated With Virologic Failure
Hide Description

Virologic failure was defined as:

  1. Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment
  2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment
  3. Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment
  4. HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24
  5. HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
  6. Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow­up, after HCV RNA < LLOQ, TND at EOT.

The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

Time Frame Follow-up Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, N signifies number of participants evaluable for this outcome measure.
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description:
Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
Overall Number of Participants Analyzed 147 146 72
Measure Type: Number
Unit of Measure: percentage of participants
Virologic Breakthrough 8.2 10.3 2.8
Week 4 Futility Rule 2.0 2.1 25.0
Detectable HCV RNA at EOT 7.5 6.8 5.6
Other Criteria 1.4 0.1 6.9
Relapse 18.5 19.0 22.0
Time Frame From start of study treatment (day 1) up to 7 days post last dose of study treatment (Week 24)
Adverse Event Reporting Description On-treatment period.
 
Arm/Group Title Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol. Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol. Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
All-Cause Mortality
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/159 (7.55%)   13/158 (8.23%)   6/78 (7.69%) 
Blood and lymphatic system disorders       
Anaemia  1  0/159 (0.00%)  1/158 (0.63%)  2/78 (2.56%) 
Febrile neutropenia  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Aplastic anaemia  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Cardiac disorders       
Atrial fibrillation  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Ear and labyrinth disorders       
Auricular perichondritis  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Gastrointestinal disorders       
Gastritis  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Abdominal pain  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Gastric ulcer haemorrhage  1  0/159 (0.00%)  2/158 (1.27%)  0/78 (0.00%) 
General disorders       
Death  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Chest pain  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Infections and infestations       
Clostridium difficile colitis  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Furuncle  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Carbuncle  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Peritonitis  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Pneumonia  1  0/159 (0.00%)  2/158 (1.27%)  1/78 (1.28%) 
Bronchitis  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Oral herpes  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Pyelonephritis  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Fall  1  0/159 (0.00%)  2/158 (1.27%)  0/78 (0.00%) 
Overdose  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Investigations       
Electrocardiogram change  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Haemoglobin decreased  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Neutrophil count decreased  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Musculoskeletal and connective tissue disorders       
Bursitis  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Rhabdomyolysis  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Muscle spasms  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Costochondritis  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Myalgia  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Nervous system disorders       
Aphasia  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Syncope  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Dizziness  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Paraesthesia  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Loss of consciousness  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Psychiatric disorders       
Adjustment disorder  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Hypomania  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Mental disorder  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Depression  1  1/159 (0.63%)  1/158 (0.63%)  0/78 (0.00%) 
Suicidal ideation  1  1/159 (0.63%)  1/158 (0.63%)  0/78 (0.00%) 
Substance-induced psychotic disorder  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Schizophrenia, paranoid type  1  0/159 (0.00%)  1/158 (0.63%)  0/78 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  0/159 (0.00%)  0/158 (0.00%)  1/78 (1.28%) 
Dyspnoea  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash generalised  1  1/159 (0.63%)  0/158 (0.00%)  0/78 (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) + Peg-interferon Alfa-2a + Ribavirin Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin Placebo + Peg-interferon Alfa-2a + Ribavirin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   156/159 (98.11%)   155/158 (98.10%)   76/78 (97.44%) 
Blood and lymphatic system disorders       
Anaemia  1  32/159 (20.13%)  21/158 (13.29%)  9/78 (11.54%) 
Neutropenia  1  26/159 (16.35%)  17/158 (10.76%)  9/78 (11.54%) 
Eye disorders       
Dry eye  1  11/159 (6.92%)  9/158 (5.70%)  4/78 (5.13%) 
Vision blurred  1  7/159 (4.40%)  6/158 (3.80%)  7/78 (8.97%) 
Gastrointestinal disorders       
Dry mouth  1  14/159 (8.81%)  8/158 (5.06%)  2/78 (2.56%) 
Nausea  1  56/159 (35.22%)  53/158 (33.54%)  20/78 (25.64%) 
Constipation  1  8/159 (5.03%)  11/158 (6.96%)  3/78 (3.85%) 
Diarrhoea  1  36/159 (22.64%)  37/158 (23.42%)  14/78 (17.95%) 
Dyspepsia  1  12/159 (7.55%)  10/158 (6.33%)  8/78 (10.26%) 
Gastrooesophageal reflux disease  1  6/159 (3.77%)  11/158 (6.96%)  2/78 (2.56%) 
Vomiting  1  19/159 (11.95%)  15/158 (9.49%)  11/78 (14.10%) 
Abdominal pain upper  1  8/159 (5.03%)  9/158 (5.70%)  5/78 (6.41%) 
Abdominal pain  1  14/159 (8.81%)  13/158 (8.23%)  2/78 (2.56%) 
General disorders       
Asthenia  1  18/159 (11.32%)  14/158 (8.86%)  7/78 (8.97%) 
Fatigue  1  88/159 (55.35%)  86/158 (54.43%)  46/78 (58.97%) 
Injection site erythema  1  10/159 (6.29%)  12/158 (7.59%)  5/78 (6.41%) 
Irritability  1  35/159 (22.01%)  37/158 (23.42%)  22/78 (28.21%) 
Influenza like illness  1  45/159 (28.30%)  49/158 (31.01%)  16/78 (20.51%) 
Chest pain  1  9/159 (5.66%)  6/158 (3.80%)  0/78 (0.00%) 
Injection site rash  1  2/159 (1.26%)  4/158 (2.53%)  6/78 (7.69%) 
Injection site reaction  1  13/159 (8.18%)  8/158 (5.06%)  6/78 (7.69%) 
Chills  1  28/159 (17.61%)  21/158 (13.29%)  16/78 (20.51%) 
Pyrexia  1  28/159 (17.61%)  20/158 (12.66%)  15/78 (19.23%) 
Infections and infestations       
Sinusitis  1  11/159 (6.92%)  3/158 (1.90%)  3/78 (3.85%) 
Lower respiratory tract infection  1  2/159 (1.26%)  1/158 (0.63%)  4/78 (5.13%) 
Oral herpes  1  6/159 (3.77%)  8/158 (5.06%)  2/78 (2.56%) 
Upper respiratory tract infection  1  8/159 (5.03%)  4/158 (2.53%)  3/78 (3.85%) 
Investigations       
Weight decreased  1  12/159 (7.55%)  8/158 (5.06%)  8/78 (10.26%) 
Metabolism and nutrition disorders       
Decreased appetite  1  27/159 (16.98%)  40/158 (25.32%)  17/78 (21.79%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  27/159 (16.98%)  28/158 (17.72%)  19/78 (24.36%) 
Muscle spasms  1  12/159 (7.55%)  9/158 (5.70%)  6/78 (7.69%) 
Back pain  1  10/159 (6.29%)  21/158 (13.29%)  8/78 (10.26%) 
Pain in extremity  1  5/159 (3.14%)  13/158 (8.23%)  3/78 (3.85%) 
Myalgia  1  45/159 (28.30%)  43/158 (27.22%)  24/78 (30.77%) 
Nervous system disorders       
Dysgeusia  1  13/159 (8.18%)  12/158 (7.59%)  4/78 (5.13%) 
Disturbance in attention  1  5/159 (3.14%)  7/158 (4.43%)  6/78 (7.69%) 
Memory impairment  1  4/159 (2.52%)  9/158 (5.70%)  0/78 (0.00%) 
Dizziness  1  22/159 (13.84%)  24/158 (15.19%)  9/78 (11.54%) 
Headache  1  68/159 (42.77%)  68/158 (43.04%)  36/78 (46.15%) 
Psychiatric disorders       
Anxiety  1  15/159 (9.43%)  15/158 (9.49%)  6/78 (7.69%) 
Depression  1  24/159 (15.09%)  21/158 (13.29%)  10/78 (12.82%) 
Insomnia  1  49/159 (30.82%)  53/158 (33.54%)  30/78 (38.46%) 
Depressed mood  1  3/159 (1.89%)  10/158 (6.33%)  5/78 (6.41%) 
Sleep disorder  1  11/159 (6.92%)  13/158 (8.23%)  4/78 (5.13%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea exertional  1  19/159 (11.95%)  19/158 (12.03%)  7/78 (8.97%) 
Dyspnoea  1  32/159 (20.13%)  26/158 (16.46%)  11/78 (14.10%) 
Cough  1  23/159 (14.47%)  31/158 (19.62%)  18/78 (23.08%) 
Oropharyngeal pain  1  9/159 (5.66%)  6/158 (3.80%)  5/78 (6.41%) 
Skin and subcutaneous tissue disorders       
Erythema  1  9/159 (5.66%)  5/158 (3.16%)  2/78 (2.56%) 
Pruritus  1  56/159 (35.22%)  63/158 (39.87%)  26/78 (33.33%) 
Dry skin  1  47/159 (29.56%)  41/158 (25.95%)  15/78 (19.23%) 
Rash  1  54/159 (33.96%)  40/158 (25.32%)  25/78 (32.05%) 
Alopecia  1  39/159 (24.53%)  41/158 (25.95%)  13/78 (16.67%) 
Hyperhidrosis  1  4/159 (2.52%)  7/158 (4.43%)  4/78 (5.13%) 
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: NCT01125189     History of Changes
Other Study ID Numbers: AI444-010
2010-018295-24 ( EudraCT Number )
First Submitted: May 17, 2010
First Posted: May 18, 2010
Results First Submitted: August 13, 2015
Results First Posted: October 23, 2015
Last Update Posted: October 23, 2015