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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

Tracking Information
First Submitted Date  ICMJE July 6, 2011
First Posted Date  ICMJE July 8, 2011
Results First Submitted Date  ICMJE August 17, 2015
Results First Posted Date  ICMJE September 16, 2015
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE September 2011
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) [ Time Frame: Post-treatment Week 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
Proportion of subjects with Sustained Virologic Response (SVR) 24, defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantification (LOQ) (detectable or undetectable) [ Time Frame: Follow-up Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2015)
  • 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 [ Time Frame: Post-treatment Week 12 ]
    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.
  • 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 [ 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 ]
    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.
  • Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points [ 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 ]
    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.
  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died [ 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]) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2011)
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: On-treatment Weeks 1 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: On-treatment Weeks 2 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: On-treatment Weeks 4 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: On-treatment Weeks 6 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: On-treatment Weeks 8 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: On-treatment Weeks 12 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: Weeks 4 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: Weeks 12 ]
  • Proportion of subjects who achieve HCV RNA < LOQ (detectable or undetectable) [ Time Frame: End of treatment or Post-treatment Week 12 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On treatment Weeks 1 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On treatment Weeks 2 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On treatment Weeks 4 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On treatment Weeks 6 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On treatment Weeks 8 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On treatment Weeks 12 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: Weeks 4 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: Weeks 12 ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: End of treatment or Post-treatment Week 12 ]
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for each cohort and overall [ Time Frame: Up to 52 weeks ]
  • Proportion of subjects with CC, CT, or TT genotype at the IL28B rs12979860 Single nucleotide polymorphism (SNP) who achieves Sustained Virologic Response (SVR) 24 [ Time Frame: Post-treatment Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BMS-790052 (Daclatasvir) Plus Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Black/African-Americans, Latinos and White/Caucasians With Hepatitis C
Official Title  ICMJE Open-Label, Single Arm Evaluation of BMS-790052 (Daclatasvir) in Combination With Peg-Interferon Alfa-2a and Ribavirin in Black-African Americans, Latinos and White-Caucasians With Chronic Hepatitis C Genotype 1 Infection
Brief Summary The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C
Intervention  ICMJE
  • Drug: Daclatasvir
    Tablet, Oral, 60 mg, once daily, 24 weeks
    Other Name: BMS-790052
  • Drug: Peg-Interferon Alfa-2a
    Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
    Other Name: Pegasys
  • Drug: Ribavirin
    Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
    Other Name: Copegus
Study Arms  ICMJE Experimental: Arm 1: Daclatasvir + Peg-Interferon Alfa-2a + Ribavirin
Interventions:
  • Drug: Daclatasvir
  • Drug: Peg-Interferon Alfa-2a
  • Drug: Ribavirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2015)
448
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2011)
230
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants chronically infected with Hepatitis C virus (HCV) genotype 1
  • HCV RNA viral load of ≥10,000 IU/mL at screening
  • No previous exposure to interferon formulation, ribavirin or HCV direct antiviral agent
  • Self-described as Black-African American, Latino or White-Caucasian
  • Results of a liver biopsy obtained ≤36 months prior to first treatment compensated cirrhotics with HCV liver biopsy from any time prior to first treatment.

Compensated cirrhotics were capped at approximately 25%

Exclusion Criteria:

  • Evidence of decompensated liver disease
  • Documented or suspected Hepatocellular carcinoma (HCC)
  • Positive for Hepatitis B or HIV 1/HIV 2 antibody at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01389323
Other Study ID Numbers  ICMJE AI444-038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP