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Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

NCT01448044•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants chronically infected with HCV Genotype 4
•HCV RNA viral load of ≥ 10,000 IU/mL
•No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
•Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

Exclusion Criteria

•Evidence of decompensated liver disease
•Documented or suspected Hepatocellular carcinoma (HCC)
•Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Locations (26)

Scti Research Foundation

San Clemente, California, United States

Umass Memorial Medical Center

Worcester, Massachusetts, United States

University Gastroenterology

Providence, Rhode Island, United States

Metropolitan Research

Annandale, Virginia, United States

Local Institution

Bondy, France

Local Institution

Créteil, France

Local Institution

La Roche-sur-Yon, France

Local Institution

Marseille, France

Local Institution

Nice, France

Local Institution

Orléans, France

Key Dates

Start Date

December 1, 2011

Primary Completion Date

October 1, 2013

Completion Date

January 1, 2014

Last Updated

October 12, 2015

Enrollment

152

ACTUAL participants

Conditions

Hepatitis C

Interventions

BMS-790052 (NS5A Replication Complex Inhibitor)

DRUG

Placebo matching BMS-790052

DRUG

Pegylated-interferon alfa 2a

DRUG

Ribavirin

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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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

Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

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