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

  Hide Study Locations
Locations
United States, Alabama
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States, 36116
United States, California
Scripps Clinic
La Jolla, California, United States, 92037
Cli
Los Angeles, California, United States, 90048
Desta Digestive Disease Medical Center
San Diego, California, United States, 92114
California Pacific Medical Center
San Francisco, California, United States, 94115
University Of California, San Francisco/Sf General Hospital
San Francisco, California, United States, 94110
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
United States, Colorado
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
University Of Florida Hepatology
Gainesville, Florida, United States, 32610
University Of Miami
Miami, Florida, United States, 33136
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States, 21229
Johns Hopkins University
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Claudia T. Martorell, Md, Llc
Springfield, Massachusetts, United States, 01105
United States, New York
James J Peters Vamc
Bronx, New York, United States, 10468
James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York, United States, 11201
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, United States, 12701
United States, North Carolina
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, United States, 27599
Carolinas Center For Liver Disease
Statesville, North Carolina, United States, 28677
United States, Oklahoma
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
Options Health Research, Llc
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
North Texas Research Institute
Arlington, Texas, United States, 76012
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States, 77030
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
United States, Wisconsin
Dean Clinic
Madison, Wisconsin, United States, 53715
Australia, New South Wales
Local Institution
Darlinghurst, New South Wales, Australia, 2010
Local Institution
Westmead Nsw, New South Wales, Australia, 2145
Australia, Queensland
Local Institution
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Local Institution
Clayton Vic, Victoria, Australia, 3168
Australia
Local Institution
Camperdown, Australia, NSW 2050
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6Z 2K5
Local Institution
Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5T 2S8
Local institution
Toronto, Ontario, Canada, M5G 2N2
Denmark
Local Institution
Aarhus, Denmark, 8200
Local Institution
Hvidovre, Denmark, 2650
Local Institution
Odense, Denmark, 5000
Egypt
Local Institution
Shebin Elkom, Menoufiya, Egypt, 35111
Local Institution
Cairo, Egypt, 11559
France
Local Institution
Creteil, France, 94000
Local Institution
Marseille Cedex 08, France, 13285
Local Institution
Montpellier Cedex 5, France, 34295
Local Instituition
Paris Cedex 12, France, 75571
Local Institution
Paris Cedex 14, France, 75679
Germany
Local Institution
Duesseldorf, Germany, 40237
Local Institution
Essen, Germany, 45122
Local Institution
Frankfurt, Germany, 60590
Local Institution
Hamburg, Germany, 20099
Italy
Local Institution
Cisanello (pisa), Italy, 56124
Local Institution
Pavia, Italy, 27100
Mexico
Local Institution
Guadalajara, Jalisco, Mexico, 44340
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00927
Sweden
Local Institution
Gothenburg, Sweden, SE-416 85
Local Institution
Stockholm, Sweden, 141 86
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
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 July 23, 2014