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Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

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

NCT01170962•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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

Locations (72)

Alabama Liver & Digestive Specialists (Alds)

Montgomery, Alabama, United States

Scripps Clinic

La Jolla, California, United States

CLI

Los Angeles, California, United States

Desta Digestive Disease Medical Center

San Diego, California, United States

University Of California At San Francisco

San Francisco, California, United States

California Pacific Medical Center

San Francisco, California, United States

Kaiser Permanente Medical Center

San Francisco, California, United States

Transplant Center And Hepatology Clinic, B-154

Aurora, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

University Of Florida Hepatology

Gainesville, Florida, United States

Key Dates

Start Date

August 1, 2010

Primary Completion Date

June 1, 2012

Completion Date

December 1, 2012

Last Updated

October 12, 2015

Enrollment

512

ACTUAL participants

Conditions

Hepatitis C Virus

Interventions

BMS-790052

DRUG

BMS-790052

DRUG

Placebo

DRUG

peginterferon alfa-2a

DRUG

ribavirin

DRUG

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

NCT05361603

Hepatitis CTransmission, Intravenous Drug Abuser+3 more

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ACTIVE_NOT_RECRUITINGPHASE3

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

NCT06868264

HEPATITIS C VIRUS CHRONIC INFECTION

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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 12, 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 of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

Inclusion Criteria

Exclusion Criteria

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo

Relinking Diagnosed But Untreated HCV Patients Back Into Care.

Screening, Treatment, and Eradication of Hep C

Trends in Risk Factors for Mother-to-Child Transmission of Hepatitis C Among a Southern European Population