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Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis

A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV

NCT02128542•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Willing and able to provide written informed consent.
•Treatment-naive or treatment-experienced adult, U.S. Veteran
•Chronic genotype 2 (GT2) HCV infection Classified as:
•* Eligible for treatment with interferon (IFN)-based therapy
•* Ineligible for IFN treatment
•* Intolerant to IFN.
•Cirrhosis determination
•Laboratory parameters within prespecified ranges at screening:
•A negative serum pregnancy test is required for females of childbearing potential
•Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
+4 more criteria

Exclusion Criteria

•Current participation in an interventional clinical trial.
•Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
•History of any other clinically significant chronic liver disease (e.g., hemochromatosis; Wilson's disease; α1-antitrypsin deficiency), except nonalcoholic steatohepatitis (NASH).
•Decompensated liver
•History of hemoglobinopathies
•Contraindication or hypersensitivity to RBV
•History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participation for the full duration of the study, such that it is not in the best interest of the individual to participate.
•Clinically significant ECG abnormality at screening.
•History of solid organ transplantation.
•Prior treatment with an NS5B polymerase inhibitor.
+8 more criteria

Locations (17)

Long Beach, California, United States

Los Angeles, California, United States

Palo Alto, California, United States

San Diego, California, United States

San Francisco, California, United States

New Haven, Connecticut, United States

Miami, Florida, United States

Decatur, Georgia, United States

Baltimore, Maryland, United States

Kansas City, Missouri, United States

Key Dates

Start Date

June 1, 2014

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

August 3, 2016

Enrollment

ACTUAL participants

Conditions

Hepatitis C Virus Infection

Interventions

Sofosbuvir

DRUG

RBV

DRUG

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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: August 3, 2016Data 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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Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis

Inclusion Criteria

Exclusion Criteria

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

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