Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
HEPCAT
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
2 other identifiers
interventional
512
11 countries
72
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 28, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
October 12, 2015
CompletedOctober 12, 2015
September 1, 2015
1.8 years
July 16, 2010
August 10, 2015
September 11, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 4, Week 12
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
SVR24 was defined as undetectable RNA (Hepatitis C Virus \[HCV\] RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
From first dose to last dose plus 7 days, up to 49 weeks
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
From day 8 post last dose of treatment up-to Week 72
Secondary Outcomes (5)
Percentage of Participants With Rapid Virologic Response (RVR)
Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)
Week 12
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Follow-up Week 12
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Baseline to follow-up Week 48
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Baseline to follow-up Week 48
Study Arms (5)
Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
EXPERIMENTAL(prior null responders)
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
EXPERIMENTAL(prior null responders)
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
EXPERIMENTAL(prior partial responders)
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
EXPERIMENTAL(prior partial responders)
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
EXPERIMENTAL(prior partial responders only)
Interventions
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Eligibility Criteria
You may qualify if:
- 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 biopsy enrollment will be capped at 25% 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, 36116, United States
Scripps Clinic
La Jolla, California, 92037, United States
CLI
Los Angeles, California, 90048, United States
Desta Digestive Disease Medical Center
San Diego, California, 92114, United States
University Of California At San Francisco
San Francisco, California, 94110, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
Kaiser Permanente Medical Center
San Francisco, California, 94118, United States
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, 80045, United States
Yale University School Of Medicine
New Haven, Connecticut, 06520, United States
University Of Florida Hepatology
Gainesville, Florida, 32610-0277, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229, United States
Johns Hopkins Medical Institutions
Lutherville, Maryland, 21093, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Samuel S. Stratton Vamc
Albany, New York, 12208, United States
James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York, 11201, United States
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, 12701, United States
University Of Rochester Medical Center
Rochester, New York, 14642, United States
James J Peters Vamc
The Bronx, New York, 10468, United States
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599-7584, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, 28677, United States
Healthcare Research Consultants
Tulsa, Oklahoma, 74135, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
North Texas Research Institute
Arlington, Texas, 76012, United States
Liver Associates Of Texas
Houston, Texas, 77030, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Dean Clinic
Madison, Wisconsin, 53715, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1121ABE, Argentina
Local Institution
Ciudad de Buenos Aires, Buenos Aires, C1181ACH, Argentina
Local Institution
Prov de Santa Fe, Santa Fe Province, 2000, Argentina
Local Institution
Randwick, New South Wales, 2031, Australia
Local Institution
Clayton, Victoria, 3168, Australia
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Heidelberg, Victoria, 3084, Australia
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Prahan, Victoria, 3004, Australia
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Fremantle, Western Australia, 6160, Australia
Local Institution
Perth, Western Australia, 6001, Australia
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Edmonton, Alberta, T6G 2B7, Canada
Local Institution
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution
Victoria, British Columbia, V8V 3P9, Canada
Local Institution
Toronto, Ontario, M5G 2N2, Canada
Local Institution
Toronto, Ontario, M5T 2S8, Canada
Local Institution
Aarhus, 8200, Denmark
Local Institution
Hvidovre, 2650, Denmark
Local Institution
Odense, 5000, Denmark
Local Institution
Clichy, 92118, France
Local Institution
Créteil, 94010, France
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Lyon, 69317, France
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Nice, 06202, France
Local Institution
Paris, 75013, France
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Paris, 75679, France
Local Institution
Vandœuvre-lès-Nancy, 54511, France
Local Institution
Essen, 45122, Germany
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Frankfurt, 60590, Germany
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Hamburg, 20099, Germany
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Hanover, 30625, Germany
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Cisanello (pisa), 56124, Italy
Local Institution
Pavia, 27100, Italy
Local Institution
Guadalajara, Jalisco, 44160, Mexico
Local Institution
Cuernavaca, Morelos, 62170, Mexico
Local Institution
Monterrey, Nuevo León, 64710, Mexico
Instituto De Investigacion Cientifica Del Sur
Ponce, 00780, Puerto Rico
Local Institution
San Juan, 00927, Puerto Rico
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Gothenburg, SE-416 85, Sweden
Local Institution
Stockholm, 14186, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 28, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
October 12, 2015
Results First Posted
October 12, 2015
Record last verified: 2015-09