Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects (HEPCAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01125189
First received: May 17, 2010
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

At least 1 dose of BMS-790052 combined with Standard of Care (pegylated interferon and ribavirin) can be identified which is safe, well tolerated, and demonstrates extended rapid virologic response rates at least 35% greater than placebo.


Condition Intervention Phase
Hepatitis C Virus
Drug: BMS-790052
Drug: Placebo
Drug: peg-interferon alfa-2a
Drug: ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b Study of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with extended rapid virologic response, defined as undetectable HCV RNA [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
  • Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response, defined as undetectable HCV RNA [ Time Frame: Follow up Week 24 ] [ Designated as safety issue: No ]
  • Safety, as measured by the frequency of Serious Adverse Events and discontinuations due to Adverse Events [ Time Frame: Week 12, Week 24, and follow-up Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the proportion of HCV genotype 1 subjects with rapid virologic response, ie, undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • To assess the proportion of HCV genotype 1 subjects with complete early virologic response, ie, undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • To assess the proportion of HCV genotype 1 subjects with 12-week sustained virologic response, ie, undetectable HCV RNA [ Time Frame: follow-up Week 12 ] [ Designated as safety issue: No ]
  • To describe resistant variants associated with virologic failure [ Time Frame: follow-up Week 48 ] [ Designated as safety issue: No ]

Enrollment: 395
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-790052 plus peg-interferon alfa-2a and ribavirin (20 mg) Drug: BMS-790052
Tablets, Oral, 20 mg, Once daily, 12-24 weeks, depending on response
Drug: peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys
Drug: ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response
Other Name: Copegus
Experimental: BMS-790052 plus peg-interferon alfa-2a and ribavirin (60 mg) Drug: BMS-790052
Tablets, Oral, 60 mg, Once daily, 12-24 weeks, depending on response
Drug: peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys
Drug: ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response
Other Name: Copegus
Placebo Comparator: Placebo plus peg-interferon alfa-2a and ribavirin Drug: Placebo
Tablets, Oral, 0 mg, Once daily, 24 weeks
Drug: peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response
Other Name: Pegasys
Drug: ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response
Other Name: Copegus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1 or 4
  • HCV RNA viral load of ≥ 100,000 IU/mL
  • No previous exposure to interferon, pegIFNα, or RBV
  • Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. Compensated cirrhotics with HCV genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
  • Ultrasound, CT scan, or MRI results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
  • Body Mass Index (BMI) of 18 to 35 kg/m²

Exclusion Criteria:

  • Positive for Hepatitis B or HIV-1/HIV-2 antibody at screening
  • Evidence of a medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125189

  Show 64 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01125189     History of Changes
Other Study ID Numbers: AI444-010, 2010-018295-24
Study First Received: May 17, 2010
Last Updated: May 31, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: National Health and Medical Research Council
Canada: Health Canada
Canada: Regulatory Affairs Division Office of Clinical Trials Therapeutic Products Directorate
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Danish National Committee on Biomedical Research Ethics
Egypt: National Ethic Committee
Egypt: Ministry of Health, Drug Policy and Planning Center
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Sanitary Risks Protection
Sweden: Medical Products Agency
Sweden: The National Board of Health and Welfare
Sweden: The Swedish Data Inspection Board
Sweden: Central Ethics Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014