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Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

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ClinicalTrials.gov Identifier: NCT01016912
Recruitment Status : Completed
First Posted : November 20, 2009
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hepatitis C Infection
Interventions Drug: BMS-790052
Drug: Placebo
Drug: Peginterferon alfa-2b
Drug: Ribavirin
Enrollment 51
Recruitment Details The study was conducted at 6 sites in Japan.
Pre-assignment Details A total of 51 participants were enrolled, of which 45 were randomized to receive treatment and 6 were discontinued for no longer meeting study criteria.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)
Hide Arm/Group Description Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Period Title: End of Treatment Period
Started 8 9 10 9 9
Received Treatment 8 9 10 9 9
Completed 8 6 9 5 5
Not Completed 0 3 1 4 4
Reason Not Completed
Lack of Efficacy             0             1             0             4             4
Adverse Event             0             1             1             0             0
Completed double-blind period only             0             1             0             0             0
Period Title: Follow-up Period
Started 8 9 [1] 10 [1] 9 [1] 9 [1]
Completed 8 9 9 8 9
Not Completed 0 0 1 1 0
Reason Not Completed
Other reason             0             0             1             1             0
[1]
Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders) Total
Hide Arm/Group Description Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin. Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin. Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin. Total of all reporting groups
Overall Number of Baseline Participants 8 9 10 9 9 45
Hide Baseline Analysis Population Description
All treated participants who received at least 1 dose of study therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 10 participants 9 participants 9 participants 45 participants
52.6  (8.78) 49.1  (15.09) 53.2  (9.96) 57.4  (6.11) 58.8  (9.46) 54.2  (10.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 10 participants 9 participants 9 participants 45 participants
Female
4
  50.0%
7
  77.8%
4
  40.0%
6
  66.7%
6
  66.7%
27
  60.0%
Male
4
  50.0%
2
  22.2%
6
  60.0%
3
  33.3%
3
  33.3%
18
  40.0%
1.Primary Outcome
Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Hide Description eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.
Time Frame At Weeks 4 and 12 on treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment Naive) Daclatasvir 10­ mg + pegINFα + Ribavirin (Nonresponders) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 25.0)
66.7
(40.1 to 87.1)
80.0
(55.0 to 94.5)
55.6
(30.1 to 79.0)
22.2
(6.1 to 49.0)
2.Secondary Outcome
Title Percentage of Participants With Rapid Virologic Response (RVR)
Hide Description RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Time Frame At Week 4 on treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 25.0)
77.8
(51.0 to 93.9)
80.0
(55.0 to 94.5)
55.6
(30.1 to 79.0)
33.3
(12.9 to 59.9)
3.Secondary Outcome
Title Percentage of Participants With Complete Early Virologic Response (cEVR)
Hide Description cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Time Frame At Week 12 on treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders) Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
62.5
(34.5 to 85.3)
77.8
(51.0 to 93.9)
100.0
(79.4 to 100.0)
55.6
(30.1 to 79.0)
55.6
(30.1 to 79.0)
4.Secondary Outcome
Title Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24
Hide Description SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA <15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Time Frame Follow-up Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
SVR4: Follow-up Week 4
75.0
(46.2 to 93.1)
66.7
(40.1 to 87.1)
90.0
(66.3 to 99.0)
22.2
(6.1 to 49.0)
33.3
(12.9 to 59.9)
SVR12: Follow-up Week 12
62.5
(34.5 to 85.3)
66.7
(40.1 to 87.1)
90.0
(66.3 to 99.0)
22.2
(6.1 to 49.0)
33.3
(12.9 to 59.9)
SVR24: Follow-up Week 24
62.5
(34.5 to 85.3)
66.7
(40.1 to 87.1)
90.0
(66.3 to 99.0)
22.2
(6.1 to 49.0)
33.3
(12.9 to 59.9)
5.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as <2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.
Time Frame From on-treatment Week 1 to Follow-up Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive) Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders) Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Unit of Measure: percentage of participants
Virologic failure 37.5 33.3 10.0 77.8 66.7
Virologic breakthrough 12.5 11.1 0.0 44.4 44.4
Relapse 25.0 11.1 10.0 33.3 22.2
6.Other Pre-specified Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Death as Outcome
Hide Description AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Time Frame From baseline to 30 days after last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive) Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg+ pegIFNα + Ribavirin (Nonresponders) Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Unit of Measure: participants
SAEs 0 0 0 1 0
Discontinuation due to AEs 0 1 1 0 0
Treatment-related AEs 8 9 10 9 9
Death 0 0 0 0 0
7.Other Pre-specified Outcome
Title Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Hide Description Clinically significant marked abnormalities in laboratory test results graded by the Division of AIDS grading table, 2004. Hemoglobin: Grade 3= <7.0 to 8.9 g/dL, Grade 4= <7.0 g/dL. Lymphocytes: Grade 3= 350-499 cells/mm^3, Grade 4= <350 cells/mm^3. Neutrophils: Grade 3= 500-999 cells/mm^3, Grade 4= <500 cells/mm^3. White blood cells (WBC): Grade 3= 1000-1499 cells/mm^3, Grade 4= <1000 cells/mm^3. Alanine aminotransferase (ALT): Grade 3= 5.1-10*upper limit of normal (ULN), Grade 4= >10.0*ULN. Aspartate aminotransferase (AST): Grade 3= 5.1-10*ULN, Grade 4= >10.0*ULN. Total bilirubin: Grade 3= 2.6-5*ULN, Grade 4= >5.0*ULN.
Time Frame From baseline to 30 days after last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of study therapy.
Arm/Group Title Placebo + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive) Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Treatment-naive) Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders) Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)
Hide Arm/Group Description:
Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
Overall Number of Participants Analyzed 8 9 10 9 9
Measure Type: Number
Unit of Measure: participants
Hemoglobin 1 0 1 3 0
Lymphocytes 2 2 3 3 2
Neutrophils 2 4 2 2 0
WBC 1 1 0 2 0
ALT 0 1 0 0 1
AST 0 1 0 0 1
Total bilirubin 0 1 0 0 0
Time Frame From baseline up to 30 days after last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo+pegIFNα +Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)
Hide Arm/Group Description Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin. Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin. Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin. Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin. Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
All-Cause Mortality
Placebo+pegIFNα +Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo+pegIFNα +Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%)   0/10 (0.00%)   1/9 (11.11%)   0/9 (0.00%) 
Infections and infestations           
Gastroenteritis  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo+pegIFNα +Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive) Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders) Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   9/9 (100.00%)   10/10 (100.00%)   9/9 (100.00%)   9/9 (100.00%) 
Blood and lymphatic system disorders           
Neutropenia  1  2/8 (25.00%)  4/9 (44.44%)  2/10 (20.00%)  2/9 (22.22%)  0/9 (0.00%) 
Lymphopenia  1  2/8 (25.00%)  2/9 (22.22%)  3/10 (30.00%)  3/9 (33.33%)  2/9 (22.22%) 
Anaemia  1  5/8 (62.50%)  2/9 (22.22%)  2/10 (20.00%)  5/9 (55.56%)  1/9 (11.11%) 
Leukopenia  1  1/8 (12.50%)  1/9 (11.11%)  0/10 (0.00%)  2/9 (22.22%)  0/9 (0.00%) 
Thrombocytopenia  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Cardiac disorders           
Ventricular extrasystoles  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Tachycardia  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Ear and labyrinth disorders           
Vertigo  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Ear pain  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Inner ear disorder  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Tinnitus  1  0/8 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  0/9 (0.00%)  1/9 (11.11%) 
Endocrine disorders           
Hypothyroidism  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  1/9 (11.11%) 
Basedow's disease  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Eye disorders           
Eye pain  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Retinal tear  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Retinopathy  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Blepharitis  1  0/8 (0.00%)  1/9 (11.11%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Conjunctivitis  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Retinal disorder  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Phosphenes  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Retinal haemorrhage  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Dry eye  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Retinal exudates  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Gastrointestinal disorders           
Diarrhoea  1  1/8 (12.50%)  3/9 (33.33%)  4/10 (40.00%)  3/9 (33.33%)  1/9 (11.11%) 
Dry mouth  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  1/9 (11.11%)  0/9 (0.00%) 
Epigastric discomfort  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Abdominal pain  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Dyspepsia  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Abdominal distension  1  1/8 (12.50%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Cheilitis  1  0/8 (0.00%)  2/9 (22.22%)  3/10 (30.00%)  0/9 (0.00%)  0/9 (0.00%) 
Vomiting  1  0/8 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  2/9 (22.22%)  2/9 (22.22%) 
Constipation  1  3/8 (37.50%)  1/9 (11.11%)  1/10 (10.00%)  1/9 (11.11%)  2/9 (22.22%) 
Dental caries  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Nausea  1  3/8 (37.50%)  1/9 (11.11%)  1/10 (10.00%)  2/9 (22.22%)  0/9 (0.00%) 
Abdominal discomfort  1  1/8 (12.50%)  2/9 (22.22%)  3/10 (30.00%)  1/9 (11.11%)  1/9 (11.11%) 
Abdominal pain upper  1  0/8 (0.00%)  2/9 (22.22%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Enterocolitis  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Lip dry  1  1/8 (12.50%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Periodontitis  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Stomatitis  1  1/8 (12.50%)  3/9 (33.33%)  3/10 (30.00%)  1/9 (11.11%)  1/9 (11.11%) 
Gingivitis  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
General disorders           
Fatigue  1  3/8 (37.50%)  0/9 (0.00%)  3/10 (30.00%)  3/9 (33.33%)  1/9 (11.11%) 
Feeling abnormal  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Injection site rash  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Vessel puncture site pain  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Injection site reaction  1  1/8 (12.50%)  1/9 (11.11%)  2/10 (20.00%)  2/9 (22.22%)  1/9 (11.11%) 
Chills  1  0/8 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  1/9 (11.11%)  0/9 (0.00%) 
Influenza like illness  1  0/8 (0.00%)  1/9 (11.11%)  1/10 (10.00%)  2/9 (22.22%)  1/9 (11.11%) 
Vessel puncture site reaction  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Chest pain  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Injection site injury  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Pyrexia  1  5/8 (62.50%)  8/9 (88.89%)  9/10 (90.00%)  6/9 (66.67%)  8/9 (88.89%) 
Injection site erythema  1  1/8 (12.50%)  2/9 (22.22%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Injection site pruritus  1  2/8 (25.00%)  3/9 (33.33%)  3/10 (30.00%)  2/9 (22.22%)  1/9 (11.11%) 
Malaise  1  2/8 (25.00%)  7/9 (77.78%)  2/10 (20.00%)  2/9 (22.22%)  1/9 (11.11%) 
Vessel puncture site pruritus  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Infections and infestations           
Gastroenteritis  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Folliculitis  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Nasopharyngitis  1  2/8 (25.00%)  5/9 (55.56%)  3/10 (30.00%)  0/9 (0.00%)  2/9 (22.22%) 
Bronchitis  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Cystitis  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  2/9 (22.22%)  2/9 (22.22%) 
Otitis externa  1  0/8 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  0/9 (0.00%)  0/9 (0.00%) 
Pharyngitis  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Atypical mycobacterial infection  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Otitis media  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Oral herpes  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Injury, poisoning and procedural complications           
Fall  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Thermal burn  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Arthropod sting  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Contusion  1  2/8 (25.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Investigations           
Blood thyroid stimulating hormone increased  1  2/8 (25.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Blood bilirubin increased  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Gamma-glutamyltransferase increased  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Weight decreased  1  3/8 (37.50%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  1/9 (11.11%) 
Alanine aminotransferase increased  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Aspartate aminotransferase increased  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Blood triglycerides increased  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Blood phosphorus decreased  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Blood pressure increased  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Lipase increased  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Metabolism and nutrition disorders           
Decreased appetite  1  1/8 (12.50%)  3/9 (33.33%)  3/10 (30.00%)  5/9 (55.56%)  2/9 (22.22%) 
Musculoskeletal and connective tissue disorders           
Intervertebral disc protrusion  1  0/8 (0.00%)  1/9 (11.11%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Temporomandibular joint syndrome  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Neck mass  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Arthralgia  1  3/8 (37.50%)  2/9 (22.22%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Muscle spasms  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Musculoskeletal stiffness  1  1/8 (12.50%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  1/9 (11.11%) 
Musculoskeletal pain  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Back pain  1  1/8 (12.50%)  0/9 (0.00%)  3/10 (30.00%)  5/9 (55.56%)  0/9 (0.00%) 
Myalgia  1  2/8 (25.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Pain in extremity  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Nervous system disorders           
Dizziness  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  2/9 (22.22%)  1/9 (11.11%) 
Dysgeusia  1  0/8 (0.00%)  0/9 (0.00%)  3/10 (30.00%)  3/9 (33.33%)  0/9 (0.00%) 
Neuropathy peripheral  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Carpal tunnel syndrome  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Migraine  1  0/8 (0.00%)  0/9 (0.00%)  2/10 (20.00%)  0/9 (0.00%)  0/9 (0.00%) 
Poor quality sleep  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Dizziness postural  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Syncope  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Headache  1  5/8 (62.50%)  6/9 (66.67%)  4/10 (40.00%)  5/9 (55.56%)  3/9 (33.33%) 
Psychiatric disorders           
Anxiety disorder  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Depressed mood  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Depression  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Insomnia  1  2/8 (25.00%)  2/9 (22.22%)  3/10 (30.00%)  0/9 (0.00%)  0/9 (0.00%) 
Renal and urinary disorders           
Nephrolithiasis  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Reproductive system and breast disorders           
Amenorrhoea  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Laryngeal inflammation  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Nasal congestion  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Dyspnoea exertional  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Oropharyngeal discomfort  1  1/8 (12.50%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Rhinitis allergic  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Dyspnoea  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Oropharyngeal pain  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Upper respiratory tract inflammation  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Cough  1  1/8 (12.50%)  0/9 (0.00%)  2/10 (20.00%)  0/9 (0.00%)  1/9 (11.11%) 
Sputum retention  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis acneiform  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Dermatitis atopic  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Erythema  1  0/8 (0.00%)  1/9 (11.11%)  0/10 (0.00%)  0/9 (0.00%)  0/9 (0.00%) 
Nail disorder  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Prurigo  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Rash  1  3/8 (37.50%)  2/9 (22.22%)  5/10 (50.00%)  0/9 (0.00%)  1/9 (11.11%) 
Pruritus  1  3/8 (37.50%)  3/9 (33.33%)  2/10 (20.00%)  1/9 (11.11%)  5/9 (55.56%) 
Pruritus generalised  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  2/9 (22.22%)  0/9 (0.00%) 
Urticaria  1  1/8 (12.50%)  0/9 (0.00%)  0/10 (0.00%)  0/9 (0.00%)  1/9 (11.11%) 
Dry skin  1  1/8 (12.50%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Eczema asteatotic  1  0/8 (0.00%)  0/9 (0.00%)  1/10 (10.00%)  0/9 (0.00%)  0/9 (0.00%) 
Alopecia  1  3/8 (37.50%)  3/9 (33.33%)  7/10 (70.00%)  3/9 (33.33%)  3/9 (33.33%) 
Drug eruption  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Eczema  1  1/8 (12.50%)  1/9 (11.11%)  2/10 (20.00%)  2/9 (22.22%)  0/9 (0.00%) 
Heat rash  1  0/8 (0.00%)  0/9 (0.00%)  0/10 (0.00%)  1/9 (11.11%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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
Name/Title: BristolMyers Squibb Study Director
Organization: Bristol­Myers Squibb International Corporation
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01016912     History of Changes
Other Study ID Numbers: AI444-021
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: August 17, 2015
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015