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Trial record 54 of 538 for:    IFNA2 AND RBV AND Hepatitis

BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C

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ClinicalTrials.gov Identifier: NCT01389323
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : September 16, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Daclatasvir
Drug: Peg-Interferon Alfa-2a
Drug: Ribavirin
Enrollment 448
Recruitment Details The study was conducted at 33 clinical sites in United States.
Pre-assignment Details A total of 448 participants were enrolled, and 246 entered treatment period. Remaining 202 did not enter treatment period (29: withdrew consent, 17: lost to follow-up, 156: no longer met study criteria). As per protocol, any participant who discontinued the treatment period was still expected to enter the post-treatment follow-up period.
Arm/Group Title Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
Period Title: Treatment Period (up to 48 Weeks)
Started 246
Completed 151
Not Completed 95
Reason Not Completed
Lack of Efficacy             41
Adverse Event             24
Participant's request to discontinue             6
Withdrawal by Subject             7
Lost to Follow-up             10
Poor/non-compliance             5
Did not meet study criteria             2
Period Title: Follow-up Period (up to 48 Weeks)
Started 221 [1]
Completed 184
Not Completed 37
Reason Not Completed
Withdrawal by Subject             10
Lost to Follow-up             22
Follow-up no longer needed per protocol             2
Other             3
[1]
Out of 246 participants who entered the treatment period, 221 continued in the follow-up period.
Arm/Group Title Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
Overall Number of Baseline Participants 246
Hide Baseline Analysis Population Description
All treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants
51.8  (9.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants
Female
69
  28.0%
Male
177
  72.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants
Hispanic or Latino
107
  43.5%
Not Hispanic or Latino
139
  56.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
128
  52.0%
White
118
  48.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 246 participants
Black/African American Latino 19
Black/African American Non-Latino 109
White Latino 88
White/Caucasian Non-Latino 30
Hepatitis C Virus RNA Levels  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 246 participants
6.21  (0.684)
Hepatitis C Virus RNA Distribution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 246 participants
<800,000 IU/mL 64
≥800,000 IU/mL 182
Hepatitis C Virus Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 246 participants
Subtype 1A 191
Subtype 1B 54
Subtype 1 1
rs12979860 Single Nucleotide Polymorphism in the Interleukin-28B Gene  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 246 participants
Wild Type (CC) 50
Heterozygous (CT) 134
Minor Homozygous (TT) 62
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)
Hide Description SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time Frame Post-treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.
Arm/Group Title Black/African American Cohort Latino Cohort White Non-Latino Cohort
Hide Arm/Group Description:
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
Overall Number of Participants Analyzed 128 107 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.8
(42.1 to 59.4)
57.0
(47.6 to 66.4)
66.7
(49.8 to 83.5)
2.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene
Hide Description SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time Frame Post-treatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.
Arm/Group Title Black/African American Cohort Latino Cohort White Non-Latino Cohort
Hide Arm/Group Description:
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
Overall Number of Participants Analyzed 128 107 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Wild Type (CC) (n=20, 24, 10)
80.0
(62.5 to 97.5)
70.8
(52.6 to 89.0)
80.0
(55.2 to 100.0)
Heterozygous (CT) (n=58, 69, 17)
53.4
(40.6 to 66.3)
50.7
(38.9 to 62.5)
58.8
(35.4 to 82.2)
Minor Homozygous (TT) (n=50, 14, 3)
36.0
(22.7 to 49.3)
64.3
(39.2 to 89.4)
66.7
(13.3 to 100.0)
3.Secondary Outcome
Title Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points
Hide Description The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time Frame Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.
Arm/Group Title Black/African American Cohort Latino Cohort White Non-Latino Cohort
Hide Arm/Group Description:
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
Overall Number of Participants Analyzed 128 107 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
32.8
(24.7 to 40.9)
44.9
(35.4 to 54.3)
33.3
(16.5 to 50.2)
Week 2
64.1
(55.8 to 72.4)
72.0
(63.5 to 80.5)
60.0
(42.5 to 77.5)
Week 4
77.3
(70.1 to 84.6)
85.0
(78.3 to 91.8)
66.7
(49.8 to 83.5)
Week 6
76.6
(69.2 to 83.9)
81.3
(73.9 to 88.7)
80.0
(65.7 to 94.3)
Week 8
76.6
(69.2 to 83.9)
81.3
(73.9 to 88.7)
76.7
(61.5 to 91.8)
Week 12
71.1
(63.2 to 78.9)
80.4
(72.8 to 87.9)
76.7
(61.5 to 91.8)
Both Weeks 4 and 12
68.0
(59.9 to 76.1)
77.6
(69.7 to 85.5)
56.7
(38.9 to 74.4)
EOT
73.4
(65.8 to 81.1)
79.4
(71.8 to 87.1)
93.3
(84.4 to 100.0)
Post-treatment Week 24
46.9
(38.2 to 55.5)
57.0
(47.6 to 66.4)
63.3
(46.1 to 80.6)
4.Secondary Outcome
Title Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points
Hide Description The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time Frame Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.
Arm/Group Title Black/African American Cohort Latino Cohort White Non-Latino Cohort
Hide Arm/Group Description:
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
Overall Number of Participants Analyzed 128 107 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
6.3
(2.1 to 10.4)
12.1
(6.0 to 18.3)
6.7
(0.0 to 15.6)
Week 2
28.1
(20.3 to 35.9)
27.1
(18.7 to 35.5)
30.0
(13.6 to 46.4)
Week 4
64.1
(55.8 to 72.4)
68.2
(59.4 to 77.0)
50.0
(32.1 to 67.9)
Week 6
68.8
(60.7 to 76.8)
75.7
(67.6 to 83.8)
66.7
(49.8 to 83.5)
Week 8
70.3
(62.4 to 78.2)
73.8
(65.5 to 82.2)
66.7
(49.8 to 83.5)
Week 12
64.1
(55.8 to 72.4)
74.8
(66.5 to 83.0)
66.7
(49.8 to 83.5)
Both Weeks 4 and 12
55.5
(46.9 to 64.1)
58.9
(49.6 to 68.2)
43.3
(25.6 to 61.1)
EOT
71.1
(63.2 to 78.9)
78.5
(70.7 to 86.3)
93.3
(84.4 to 100.0)
Post-treatment Week 12
50.8
(42.1 to 59.4)
55.1
(45.7 to 64.6)
63.3
(46.1 to 80.6)
Post-treatment Week 24
46.9
(38.2 to 55.5)
55.1
(45.7 to 64.6)
63.3
(46.1 to 80.6)
5.Secondary Outcome
Title Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died
Hide Description An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; 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. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.
Time Frame From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants for TP and all follow-up participants for FUP. Here, "n" signifies the number of participants evaluable in their respective study periods.
Arm/Group Title Black/African American Cohort White/Caucasian Cohort Latino Cohort Non-Latino Cohort Overall Population
Hide Arm/Group Description:
Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
Overall Number of Participants Analyzed 128 118 107 139 246
Measure Type: Number
Unit of Measure: participants
SAEs: TP (n=128,118,107,139,246) 12 9 5 16 21
Discontinued due to AE: TP (n=128,118,107,139,246) 9 15 6 18 24
Treatment-related AEs: TP (n=128,118,107,139,246) 111 108 93 126 219
Deaths: TP (n=128,118,107,139,246) 0 0 0 0 0
SAEs: FUP (n=117,104,96,125,221) 3 0 1 2 3
Deaths: FUP (n=117,104,96,125,221) 0 0 0 0 0
Time Frame From first dose to 7 days post last dose of study treatment
Adverse Event Reporting Description On-treatment Period
 
Arm/Group Title Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Hide Arm/Group Description Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
All-Cause Mortality
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Affected / at Risk (%)
Total   21/246 (8.54%) 
Blood and lymphatic system disorders   
Anaemia  1  3/246 (1.22%) 
Cardiac disorders   
Acute coronary syndrome  1  1/246 (0.41%) 
Gastrointestinal disorders   
Colitis  1  1/246 (0.41%) 
Lower gastrointestinal haemorrhage  1  1/246 (0.41%) 
Melaena  1  1/246 (0.41%) 
Gastric ulcer  1  1/246 (0.41%) 
General disorders   
Chest pain  1  5/246 (2.03%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/246 (0.41%) 
Infections and infestations   
Gangrene  1  1/246 (0.41%) 
Pneumonia  1  1/246 (0.41%) 
Osteomyelitis  1  1/246 (0.41%) 
Gastroenteritis  1  1/246 (0.41%) 
Cellulitis  1  1/246 (0.41%) 
Injury, poisoning and procedural complications   
Animal bite  1  1/246 (0.41%) 
Overdose  1  1/246 (0.41%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1  1/246 (0.41%) 
Nervous system disorders   
Cerebrovascular accident  1  1/246 (0.41%) 
Intracranial aneurysm  1  1/246 (0.41%) 
Syncope  1  2/246 (0.81%) 
Headache  1  1/246 (0.41%) 
Paraesthesia  1  1/246 (0.41%) 
Psychiatric disorders   
Drug abuse  1  1/246 (0.41%) 
Substance abuse  1  1/246 (0.41%) 
Renal and urinary disorders   
Renal failure acute  1  1/246 (0.41%) 
Reproductive system and breast disorders   
Ovarian cyst  1  1/246 (0.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin
Affected / at Risk (%)
Total   227/246 (92.28%) 
Blood and lymphatic system disorders   
Neutropenia  1  57/246 (23.17%) 
Thrombocytopenia  1  17/246 (6.91%) 
Anaemia  1  73/246 (29.67%) 
Gastrointestinal disorders   
Vomiting  1  15/246 (6.10%) 
Nausea  1  61/246 (24.80%) 
Diarrhoea  1  30/246 (12.20%) 
General disorders   
Influenza like illness  1  47/246 (19.11%) 
Injection site reaction  1  13/246 (5.28%) 
Chills  1  35/246 (14.23%) 
Fatigue  1  107/246 (43.50%) 
Pain  1  21/246 (8.54%) 
Pyrexia  1  23/246 (9.35%) 
Investigations   
Weight decreased  1  15/246 (6.10%) 
Metabolism and nutrition disorders   
Decreased appetite  1  34/246 (13.82%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  16/246 (6.50%) 
Myalgia  1  18/246 (7.32%) 
Arthralgia  1  24/246 (9.76%) 
Nervous system disorders   
Dizziness  1  25/246 (10.16%) 
Headache  1  77/246 (31.30%) 
Psychiatric disorders   
Anxiety  1  13/246 (5.28%) 
Insomnia  1  46/246 (18.70%) 
Depression  1  24/246 (9.76%) 
Irritability  1  26/246 (10.57%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  23/246 (9.35%) 
Cough  1  19/246 (7.72%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  31/246 (12.60%) 
Pruritus  1  43/246 (17.48%) 
Alopecia  1  28/246 (11.38%) 
Rash  1  58/246 (23.58%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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: BristolMyers Squibb Study Director
Organization: BristolMyers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01389323     History of Changes
Other Study ID Numbers: AI444-038
First Submitted: July 6, 2011
First Posted: July 8, 2011
Results First Submitted: August 17, 2015
Results First Posted: September 16, 2015
Last Update Posted: October 12, 2015