Clinical trial NCT01170962: Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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

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

Primary outcomes:
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: Week 4, Week 12
measure: Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
timeFrame: Follow-up Week 24
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
timeFrame: From first dose to last dose plus 7 days, up to 49 weeks
measure: Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
timeFrame: From day 8 post last dose of treatment up-to Week 72
Secondary outcomes:
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Percentage of Participants With Complete Early Virologic Response (cEVR)
timeFrame: Week 12
measure: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
timeFrame: Follow-up Week 12
measure: Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
timeFrame: Baseline to follow-up Week 48
measure: Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
timeFrame: Baseline to follow-up Week 48
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: CLI
state: California
city: San Diego
country: United States
facility: Desta Digestive Disease Medical Center
state: California
city: San Francisco
country: United States
facility: University Of California At San Francisco
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Aurora
country: United States
facility: Transplant Center And Hepatology Clinic, B-154
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University Of Florida Hepatology
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Lutherville
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Albany
country: United States
facility: Samuel S. Stratton Vamc
state: New York
city: Bronx
country: United States
facility: James J Peters Vamc
state: New York
city: Great Neck
country: United States
facility: James Sungsik Park, M.D. C.N.S.C.
state: New York
city: Monticello
country: United States
facility: Upper Delaware Valley Infectious Diseases, Pc
state: New York
city: Rochester
country: United States
facility: University Of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina, Chapel Hill
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center For Liver Disease
state: North Carolina
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Arlington
country: United States
facility: North Texas Research Institute
state: Texas
city: Houston
country: United States
facility: Liver Associates Of Texas
state: Texas
city: Houston
country: United States
facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Clayton
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Prahan
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Perth
country: Australia
facility: Local Institution
state: Western Australia
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Aarhus
country: Denmark
facility: Local Institution
city: Hvidovre
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: Lyon Cedex 04
country: France
facility: Local Institution
city: Nice Cedex 03
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Paris Cedex
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Ponce
country: Puerto Rico
facility: Instituto De Investigacion Cientifica Del Sur
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: