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Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

NCT01012895•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female subjects ages 18 to 70 years
•HCV-Infected Genotype 1 Null responders to current standard of care
•Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Exclusion Criteria

•Evidence of a medical condition associate with chronic liver disease other than HCV
•History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
•History of Cancer within 5 years of enrollment
•History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
•History of clinically significant cardiac disease
•History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
•Documented cirrhosis within 12 months prior to dosing
•Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
•Pregnant

Locations (18)

Advanced Clinical Research Institute

Anaheim, California, United States

Southern California Liver Centers

Coronado, California, United States

San Jose Gastroenterology

San Jose, California, United States

University Of Colorado Denver & Hospital

Aurora, Colorado, United States

Mercy Medical Center

Baltimore, Maryland, United States

University Of Michigan Health System

Ann Arbor, Michigan, United States

Carolinas Center For Liver Disease

Statesville, North Carolina, United States

Texas Clinical Research Institute, Llc

Arlington, Texas, United States

Alamo Medical Research

San Antonio, Texas, United States

Metropolitan Research

Fairfax, Virginia, United States

Key Dates

Start Date

December 1, 2009

Primary Completion Date

October 1, 2012

Completion Date

February 1, 2014

Last Updated

October 9, 2015

Enrollment

215

ACTUAL participants

Conditions

Chronic Hepatitis C

Interventions

BMS-790052

DRUG

BMS-650032

DRUG

BMS-650032

DRUG

BMS-650032

DRUG

Pegylated-interferon alfa-2a

DRUG

Ribavirin

DRUG

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

NCT00199719

Chronic Hepatitis C

View study

COMPLETEDPHASE4

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

NCT06922643

Chronic Hepatitis C

View study

COMPLETEDNA

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Inclusion Criteria

Exclusion Criteria

Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

Changes in Liver Fibrosis, Lipid Profile and Insulin Resistance in HCV Patients Who Received Antiviral Therapy

Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection