Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

Hepatitis C Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030432
• Other study ID #: AI447-016
• Secondary ID: 2009-013652-69
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2009
• Last updated: September 23, 2015
• Start date: February 2010
• Est. completion date: October 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Ministry of HealthArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines BoardSpain: Spanish Agency of MedicinesItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
• BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
• Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
• Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
• Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
• Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
• Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
• Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
• Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Prov De Santa Fe	Santa Fe
Argentina	Local Institution	Prov. Buenos Aires	Buenos Aires
France	Local Institution	Creteil Cedex
France	Local Institution	Marseille Cedex 08
France	Local Instituition	Montpellier Cedex 5
France	Local Institution	Paris Cedex 13
France	Local Institution	Paris Cedex 14
France	Local Institution	Vandoeuvre Les Nancy
Germany	Local Institution	Frankfurt
Germany	Local Institution	Heidelberg
Germany	Local Institution	Mainz
Germany	Local Institution	Wurzburg
Ireland	Local Institution	Dublin
Italy	Local Institution	Torino
Spain	Local Institution	Alicante
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Malaga
Spain	Local Institution	Valencia
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United States	Mercy Medical Center	Baltimore	Maryland
United States	University Of Alabama At Birmingham	Birmingham	Alabama
United States	James J Peters Vamc	Bronx	New York
United States	University Of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Metropolitan Research	Fairfax	Virginia
United States	Gastro One	Germantown	Tennessee
United States	Dean Clinic	Madison	Wisconsin
United States	Alabama Liver & Digestive Specialists (Alds)	Montgomery	Alabama
United States	Florida Hospital Transplant Center	Orlando	Florida
United States	Hospital Of The University Of Pennsylvania	Philadelphia	Pennsylvania
United States	Oregon Health Science Univ	Portland	Oregon
United States	The Research Institute	Springfield	Massachusetts
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Umass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  France,  Germany,  Ireland,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs		12 weeks after first dose	Yes
Primary	Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA		Week 4	Yes
Primary	Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA		Week 12	Yes
Primary	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		at follow-up Week 24	Yes
Secondary	Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4		Week 4	No
Secondary	Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only)		at Week 12 (Stage 2 only)	No
Secondary	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)		Week 12 (Stage 1 only)	No
Secondary	Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12		follow-up Week 12	No
Secondary	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)		follow-up Week 24 (Stage 1 only)	No
Secondary	Resistant variants associated with virologic failure		48 weeks after last dose	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form