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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01389323
First received: July 6, 2011
Last updated: March 28, 2013
Last verified: October 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 230
Study Start Date: September 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389323

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

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01389323     History of Changes
Other Study ID Numbers: AI444-038
Study First Received: July 6, 2011
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
 Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013