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Ph IIA Study (SOC +/- NS5B) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Ph IIA Study (SOC +/- NS5B)

A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

NCT01193361•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
•HCV RNA ≥ 10\*5\* IU/mL at Screening
•Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
•Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
•Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² at Screening

Exclusion Criteria

•Liver transplant recipients
•Documented or suspected HCC by imaging or liver biopsy
•Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
•History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
•Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

Locations (10)

Advanced Clinical Research Institute

Anaheim, California, United States

Loyola University Medical Center

Maywood, Illinois, United States

Mercy Medical Center

Baltimore, Maryland, United States

Digestive Disease Associates, P.A.

Baltimore, Maryland, United States

Claudia T. Martorell, Md, Llc

Springfield, Massachusetts, United States

Charlotte Gastroenterology & Hepatology, Pllc

Charlotte, North Carolina, United States

Options Health Research, Llc

Tulsa, Oklahoma, United States

The North Texas Research Institute

Arlington, Texas, United States

Alamo Medical Research

San Antonio, Texas, United States

Metropolitan Research

Fairfax, Virginia, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

June 1, 2011

Completion Date

November 1, 2012

Last Updated

October 9, 2015

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus

Interventions

BMS-791325

DRUG

BMS-791325

DRUG

Placebo

DRUG

Peg-interferon 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

View study

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

View study

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.

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Ph IIA Study (SOC +/- NS5B)

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