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Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01170962
First received: July 16, 2010
Last updated: June 18, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and Ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and Ribavirin alone.


Condition Intervention Phase
Hepatitis C Virus
 Drug: BMS-790052
Drug: Placebo
Drug: peginterferon 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)
Primary Purpose: Treatment
Official Title: A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

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 eRVR (undetectable HCV RNA at Weeks 4 and 12) [ Time Frame: Week 12 Analysis ] [ Designated as safety issue: No ]
  • Proportion of subjects with 24-week SVR (undetectable HCV RNA at follow-up week 24) [ Time Frame: Post-treatment Week 24 Analysis ] [ Designated as safety issue: No ]
  • Safety measured by frequency of SAEs & discontinuation due to AEs [ Time Frame: Week 12 Analysis ] [ Designated as safety issue: No ]
  • Safety measured by frequency of SAEs & discontinuation due to AEs [ Time Frame: Post-treatment Week 4 Analysis ] [ Designated as safety issue: No ]
  • Safety measured by frequency of SAEs & discontinuation due to AEs [ Time Frame: Post-treatment Week 12 Analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with rapid virologic response (RVR) [ Time Frame: Week 12 Analysis ] [ Designated as safety issue: No ]
  • Proportion of subjects with complete early virologic response (cEVR) [ Time Frame: Week 12 Analysis ] [ Designated as safety issue: No ]
  • Proportion of subjects with SVR12 [ Time Frame: Post-treatment Week 12 Analysis ] [ Designated as safety issue: No ]
  • Frequency of genotypic substitutions associated with virologic failure [ Time Frame: Post-treatment Week 48 Analysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 425
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
 Drug: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Drug: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 weeks
Other Name: Pegasys®
Drug: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, once daily, 48 weeks
Other Name: Copegus®
Experimental: Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
 Drug: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily, 24 weeks
Drug: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 weeks
Other Name: Pegasys®
Drug: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, once daily, 48 weeks
Other Name: Copegus®
Experimental: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
 Drug: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Drug: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 weeks
Other Name: Pegasys®
Drug: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, once daily, 48 weeks
Other Name: Copegus®
Experimental: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
 Drug: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily, 24 weeks
Drug: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 weeks
Other Name: Pegasys®
Drug: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, once daily, 48 weeks
Other Name: Copegus®
Experimental: Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
 Drug: Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
Drug: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 weeks
Other Name: Pegasys®
Drug: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, once daily, 48 weeks
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
  • Non-responder to prior therapy with peginterferon alfa and ribavirin
  • HCV RNA viral load of ≥ 100,00 IU/mL
  • Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics will be capped at 10% of randomized study population)
  • Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
  • Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion Criteria:

  • Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
  • Evidence of medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170962

  Show 70 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  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: NCT01170962     History of Changes
Other Study ID Numbers: AI444-011, 2010-019378-34
Study First Received: July 16, 2010
Last Updated: June 18, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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: The Danish National Committee on Biomedical Research Ethics
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
Italy: Ministry of Health
Italy: National Bioethics Committee
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: Institutional Review Board
United States: Food and Drug Administration

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
 Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 17, 2012