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Trial record 12 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

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ClinicalTrials.gov Identifier: NCT01257204
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : December 14, 2015
Last Update Posted : December 14, 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: Placebo
Drug: Daclatasvir
Drug: Pegylated interferon alfa-2a
Drug: Ribavirin
Enrollment 196
Recruitment Details  
Pre-assignment Details A total of 196 participants were enrolled, of which 152 participants were randomized; remaining 44 participants did not meet study criteria. Of randomized participants:151 were treated; 1 participant withdrew consent.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα­2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks. Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks. Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
Period Title: Treatment Period (up to Week 24)
Started 50 50 51
Completed 45 44 42
Not Completed 5 6 9
Reason Not Completed
Lack of Efficacy             0             1             3
Adverse Event             3             1             2
Withdrawal by Subject             1             0             1
Lost to Follow-up             0             2             0
Poor compliance/noncompliance             0             0             1
Participant's request to discontinue             1             2             2
Period Title: Follow-up Period (up to Week 48)
Started 49 [1] 47 [1] 49 [1]
Completed 48 41 39
Not Completed 1 6 10
Reason Not Completed
Withdrawal by Subject             0             2             1
Lost to Follow-up             1             4             4
Other             0             0             5
[1]
Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.
Arm/Group Title Dacalatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo Total
Hide Arm/Group Description Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks. Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks. Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 50 50 51 151
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 51 participants 151 participants
47.5  (8.42) 47.5  (9.20) 48.8  (9.73) 47.9  (9.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 51 participants 151 participants
Female
18
  36.0%
13
  26.0%
24
  47.1%
55
  36.4%
Male
32
  64.0%
37
  74.0%
27
  52.9%
96
  63.6%
Hepatitis C Virus (HCV) RNA (IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 50 participants 50 participants 51 participants 151 participants
6.4  (0.82) 6.6  (0.62) 6.6  (0.59) 6.5  (0.69)
HCV RNA Distribution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 51 participants 151 participants
<800,000 IU/mL 12 7 6 25
≥800,000 IU/mL 38 43 45 126
Randomization Stratum  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 51 participants 151 participants
HCV Genotype 2 24 23 24 71
HCV Genotype 3 26 27 27 80
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 51 participants 151 participants
Absent 43 43 41 127
Present 7 4 8 19
Not Reported 0 3 2 5
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
Hide Description SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], 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 with hepatitis C virus genotype 2.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 24 23 24
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
83.3
(73.6 to 93.1)
82.6
(72.5 to 92.7)
62.5
(49.8 to 75.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Daclatasvir, 60 mg, 12-Week Cohort, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 20.8
Confidence Interval (2-Sided) 80%
4.9 to 36.8
Estimation Comments The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Daclatasvir, 60 mg, 16-Week Cohort, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 20.1
Confidence Interval (2-Sided) 80%
3.9 to 36.3
Estimation Comments The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
2.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
Hide Description SVR24 was defined as undetectable HCV RNA (HCV RNA <lower limit of quantitation [LLOQ], 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 with HCV genotype 3.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 26 27 27
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
69.2
(57.6 to 80.8)
66.7
(55.0 to 78.3)
59.3
(47.1 to 71.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Daclatasvir, 60 mg, 12-Week Cohort, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.0
Confidence Interval (2-Sided) 80%
-6.8 to 26.7
Estimation Comments The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Daclatasvir, 60 mg, 16-Week Cohort, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 7.4
Confidence Interval (2-Sided) 80%
-9.4 to 24.2
Estimation Comments The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.
3.Secondary Outcome
Title Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
Hide Description RVR was defined as undetectable HCV 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.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 2.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 24 23 24
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(78.8 to 96.2)
73.9
(62.2 to 85.6)
41.7
(28.8 to 54.6)
4.Secondary Outcome
Title Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
Hide Description RVR was defined as undetectable HCV 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.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 3.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 26 27 27
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
84.6
(75.5 to 93.7)
74.1
(63.3 to 84.9)
37.0
(25.1 to 48.9)
5.Secondary Outcome
Title Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
Hide Description cEVR was defined as undetectable HCV 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 2.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 24 23 24
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
91.7
(84.4 to 98.9)
82.6
(72.5 to 92.7)
75.0
(63.7 to 86.3)
6.Secondary Outcome
Title Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
Hide Description cEVR was defined as undetectable HCV 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 3.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Dacalatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 26 27 27
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
80.8
(70.9 to 90.7)
88.9
(81.1 to 96.6)
59.3
(47.1 to 71.4)
7.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
Hide Description SVR12 was defined as undetectable HCV 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.
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 2.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 24 23 24
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(78.8 to 96.2)
82.6
(72.5 to 92.7)
70.8
(58.9 to 82.7)
8.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
Hide Description SVR12 was defined as undetectable HCV 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.
Time Frame Follow-up Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 3.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 26 27 27
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
69.2
(57.6 to 80.8)
77.8
(67.5 to 88.0)
51.9
(39.5 to 64.2)
9.Secondary Outcome
Title Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
Hide Description

Virologic failure was defined as:

  1. Virologic breakthrough: confirmed >1 log10 increase in 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 or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
  5. Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, 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.

Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 2. Here, "n" signifies the number of participants evaluable for the respective category.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 24 23 24
Measure Type: Number
Unit of Measure: participants
Virologic breakthrough (n=24,23,24) 0 1 1
<1 log10 decrease in HCV RNA at Week4 (n=24,23,24) 0 1 0
HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=24,23,24) 1 2 1
Relapse (n=23,21,22) 1 0 2
10.Secondary Outcome
Title Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
Hide Description

Virologic failure was defined as:

  1. Virologic breakthrough: confirmed >1 log10 increase in 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 or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)
  5. Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, 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.

Time Frame Baseline up to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants with HCV genotype 3. Here, "n" signifies the number of participants evaluable for the respective category.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 26 27 27
Measure Type: Number
Unit of Measure: participants
Virologic breakthrough (n=26,27,27) 0 0 1
<1 log10 decrease in HCV RNA at Week4 (n=26,27,27) 0 1 3
HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=26,27,27) 1 2 3
Relapse (n=25,24,21) 6 6 3
11.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
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. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.
Time Frame Baseline (Day 1) up to 24 weeks (treatment period)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
Overall Number of Participants Analyzed 50 50 51
Measure Type: Number
Unit of Measure: participants
AEs 49 49 50
SAEs 4 0 3
Discontinuations due to AEs 4 3 2
Grade 2-4 Treatment-related AEs 27 22 30
Deaths 0 0 0
12.Secondary Outcome
Title Number of Participants With Adverse Events (AEs), 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 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.
Time Frame From end of treatment period up to Week 48 (follow-up period)
Hide Outcome Measure Data
Hide Analysis Population Description
All follow-up participants.
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort: Follow-up Daclatasvir, 60 mg, 16-Week Cohort: Follow-up Placebo: Follow-up
Hide Arm/Group Description:
Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.
Overall Number of Participants Analyzed 49 47 49
Measure Type: Number
Unit of Measure: participants
AEs 16 12 11
SAEs 2 0 0
Deaths 0 0 0
Time Frame Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo Daclatasvir, 60 mg, 12-Week Cohort: Follow-up Daclatasvir, 60 mg, 16-Week Cohort: Follow-up Placebo: Follow-up
Hide Arm/Group Description Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks. Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks. Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks. Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period. Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period. Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
All-Cause Mortality
Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo Daclatasvir, 60 mg, 12-Week Cohort: Follow-up Daclatasvir, 60 mg, 16-Week Cohort: Follow-up Placebo: Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo Daclatasvir, 60 mg, 12-Week Cohort: Follow-up Daclatasvir, 60 mg, 16-Week Cohort: Follow-up Placebo: Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/50 (8.00%)   0/50 (0.00%)   3/51 (5.88%)   2/49 (4.08%)   0/47 (0.00%)   0/49 (0.00%) 
Gastrointestinal disorders             
Abdominal pain upper  1  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Rectal ulcer haemorrhage  1  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Gastrointestinal inflammation  1  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
General disorders             
Adhesion  1  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/49 (2.04%)  0/47 (0.00%)  0/49 (0.00%) 
Hepatobiliary disorders             
Biliary colic  1  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Hyperbilirubinaemia  1  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Infections and infestations             
Appendiceal Abscess  1  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/49 (2.04%)  0/47 (0.00%)  0/49 (0.00%) 
Injury, poisoning and procedural complications             
Epicondylitis  1  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Hepatic neoplasm malignant  1  1/50 (2.00%)  0/50 (0.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Tonsil Cancer  1  0/50 (0.00%)  0/50 (0.00%)  0/51 (0.00%)  1/49 (2.04%)  0/47 (0.00%)  0/49 (0.00%) 
Psychiatric disorders             
Conversion disorder  1  0/50 (0.00%)  0/50 (0.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir, 60 mg, 12-Week Cohort Daclatasvir, 60 mg, 16-Week Cohort Placebo Daclatasvir, 60 mg, 12-Week Cohort: Follow-up Daclatasvir, 60 mg, 16-Week Cohort: Follow-up Placebo: Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   49/50 (98.00%)   49/50 (98.00%)   48/51 (94.12%)   0/49 (0.00%)   0/47 (0.00%)   0/49 (0.00%) 
Blood and lymphatic system disorders             
Neutropenia  1  4/50 (8.00%)  3/50 (6.00%)  8/51 (15.69%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Thrombocytopenia  1  1/50 (2.00%)  1/50 (2.00%)  4/51 (7.84%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Anaemia  1  4/50 (8.00%)  3/50 (6.00%)  5/51 (9.80%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Eye disorders             
Vision blurred  1  3/50 (6.00%)  1/50 (2.00%)  2/51 (3.92%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  7/50 (14.00%)  1/50 (2.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Gastrooesophageal reflux disease  1  2/50 (4.00%)  1/50 (2.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dry mouth  1  3/50 (6.00%)  0/50 (0.00%)  2/51 (3.92%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dyspepsia  1  1/50 (2.00%)  1/50 (2.00%)  4/51 (7.84%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Vomiting  1  2/50 (4.00%)  2/50 (4.00%)  4/51 (7.84%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Diarrhoea  1  5/50 (10.00%)  5/50 (10.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Nausea  1  10/50 (20.00%)  12/50 (24.00%)  8/51 (15.69%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
General disorders             
Influenza like illness  1  10/50 (20.00%)  9/50 (18.00%)  7/51 (13.73%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Injection site reaction  1  3/50 (6.00%)  2/50 (4.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Asthenia  1  6/50 (12.00%)  7/50 (14.00%)  7/51 (13.73%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Fatigue  1  23/50 (46.00%)  12/50 (24.00%)  19/51 (37.25%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Injection site erythema  1  5/50 (10.00%)  5/50 (10.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Chills  1  3/50 (6.00%)  1/50 (2.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Irritability  1  8/50 (16.00%)  9/50 (18.00%)  6/51 (11.76%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Pyrexia  1  5/50 (10.00%)  2/50 (4.00%)  2/51 (3.92%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Infections and infestations             
Nasopharyngitis  1  0/50 (0.00%)  1/50 (2.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Oral herpes  1  0/50 (0.00%)  3/50 (6.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  4/50 (8.00%)  8/50 (16.00%)  8/51 (15.69%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Musculoskeletal and connective tissue disorders             
Myalgia  1  9/50 (18.00%)  5/50 (10.00%)  11/51 (21.57%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Arthralgia  1  5/50 (10.00%)  6/50 (12.00%)  9/51 (17.65%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Back pain  1  5/50 (10.00%)  2/50 (4.00%)  6/51 (11.76%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Nervous system disorders             
Disturbance in attention  1  1/50 (2.00%)  3/50 (6.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dysgeusia  1  0/50 (0.00%)  5/50 (10.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dizziness  1  2/50 (4.00%)  4/50 (8.00%)  6/51 (11.76%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Memory impairment  1  2/50 (4.00%)  1/50 (2.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Headache  1  15/50 (30.00%)  15/50 (30.00%)  9/51 (17.65%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Psychiatric disorders             
Sleep disorder  1  3/50 (6.00%)  3/50 (6.00%)  2/51 (3.92%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Depression  1  4/50 (8.00%)  7/50 (14.00%)  9/51 (17.65%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Insomnia  1  11/50 (22.00%)  8/50 (16.00%)  17/51 (33.33%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Anxiety  1  2/50 (4.00%)  0/50 (0.00%)  4/51 (7.84%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Mood swings  1  3/50 (6.00%)  1/50 (2.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  5/50 (10.00%)  3/50 (6.00%)  8/51 (15.69%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dyspnoea  1  5/50 (10.00%)  7/50 (14.00%)  6/51 (11.76%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dyspnoea exertional  1  2/50 (4.00%)  3/50 (6.00%)  2/51 (3.92%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Oropharyngeal pain  1  1/50 (2.00%)  2/50 (4.00%)  3/51 (5.88%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Epistaxis  1  1/50 (2.00%)  3/50 (6.00%)  0/51 (0.00%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Skin and subcutaneous tissue disorders             
Pruritus  1  14/50 (28.00%)  13/50 (26.00%)  14/51 (27.45%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Alopecia  1  7/50 (14.00%)  5/50 (10.00%)  5/51 (9.80%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Erythema  1  1/50 (2.00%)  4/50 (8.00%)  1/51 (1.96%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Dry skin  1  2/50 (4.00%)  11/50 (22.00%)  6/51 (11.76%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Rash  1  13/50 (26.00%)  12/50 (24.00%)  12/51 (23.53%)  0/49 (0.00%)  0/47 (0.00%)  0/49 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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
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: NCT01257204     History of Changes
Other Study ID Numbers: AI444-031
2010-022408-28 ( EudraCT Number )
First Submitted: December 1, 2010
First Posted: December 9, 2010
Results First Submitted: August 5, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015