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

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: July 6, 2011
Last updated: March 4, 2015
Last verified: March 2015

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.

Condition Intervention Phase
Hepatitis C
Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
Drug: Peg-Interferon Alfa-2a
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Proportion of subjects with Sustained Virologic Response (SVR) 12, defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantification (LOQ) (detectable or undetectable) for each cohort [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for each cohort and overall [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with CC, CT, or TT genotype at the IL28B rs12979860 Single nucleotide polymorphism (SNP) who achieves Sustained Virologic Response (SVR) 12 [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HCV RNA < LOQ [ Time Frame: On-treatment Weeks 1, 2, 4, 6, 8, 12; at both Weeks 4 and 12; End of treatment (EOT) [up to 48 weeks], or post-treatment Week 24 (SVR24) ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: On-treatment Weeks 1, 2, 4, 6, 8, 12; at both Weeks 4 and 12; End of treatment (EOT) [up to 48 weeks], post-treatment week 12 or post-treatment Week 24 ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-790052 + Peg-Interferon Alfa-2a + Ribavirin Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
Tablet, Oral, 60 mg, once daily, 24 weeks
Other Name: Daclatasvir
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects chronically infected with HCV (Hepatitis C virus) genotype 1
  • HCV Ribonucleic acid (RNA) viral load of ≥ 10,000 IU/mL at screening
  • No previous exposure to interferon formulation, Ribavirin (RBV) 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 can be from any time prior to first treatment. Compensated cirrhotics will be capped at approximately 25%

Exclusion Criteria:

  • Evidence of decompensated liver disease
  • Documented or suspected Hepatocellular carcinoma (HCC)
  • Positive for Hepatitis B or Human immunodeficiency virus 1/Human immunodeficiency virus 2 antibody at screening
  Contacts and Locations
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Please refer to this study by its identifier: NCT01389323

  Show 36 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb Identifier: NCT01389323     History of Changes
Other Study ID Numbers: AI444-038
Study First Received: July 6, 2011
Last Updated: March 4, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on August 27, 2015