Clinical trial NCT01030432: Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
Official title: A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 285
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 identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Eligibility criteria: Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
* Subjects chronically infected with HCV genotype 4 (Phase 2b only)
* HCV RNA viral load of ≥ 10\*5\* IU/mL at screening
* BMI of 18 - 35 kg/m² at screening

Exclusion Criteria:

* Cirrhosis (Phase 2a only)
* Decompensated cirrhosis (Phase 2b)
* Co-infection with HBV or HIV
* Hepatocellular carcinoma
* Prior treatment with anti-HCV drugs

Primary outcomes:
measure: Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs
timeFrame: 12 weeks after first dose
measure: Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
timeFrame: Week 4
measure: Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
timeFrame: Week 12
measure: Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA
timeFrame: at follow-up Week 24
Secondary outcomes:
measure: Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4
timeFrame: Week 4
measure: Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)
timeFrame: at Week 12 (Stage 2 only)
measure: Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only)
timeFrame: Week 12 (Stage 1 only)
measure: Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12
timeFrame: follow-up Week 12
measure: Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only)
timeFrame: follow-up Week 24 (Stage 1 only)
measure: Resistant variants associated with virologic failure
timeFrame: 48 weeks after last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham
state: Alabama
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: Orlando
country: United States
facility: Florida Hospital Transplant Center
state: Florida
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: James J Peters Vamc
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina, Chapel Hill
state: North Carolina
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health Science Univ
state: Oregon
city: Philadelphia
country: United States
facility: Hospital Of The University Of Pennsylvania
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
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: Prov. Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: Marseille Cedex 08
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Instituition
city: Paris Cedex 13
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Wurzburg
country: Germany
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Alicante
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.