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Phase 3 Study of Sofosbuvir and Ribavirin | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Phase 3 Study of Sofosbuvir and Ribavirin

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection

NCT01497366•Gilead Sciences

View on ClinicalTrials.gov

Summary

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Chronic Genotype 2 or 3 HCV-infection
•Naive to all HCV antiviral treatment(s)

Exclusion Criteria

•Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
•History of any other clinically significant chronic liver disease
•A history consistent with decompensated liver disease
•History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
•Participation in a clinical study within 3 months prior to first dose

Locations (97)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Alabama Liver & Digestive Specialist

Montgomery, Alabama, United States

Franco Felizarta, MD

Bakersfield, California, United States

California Liver Institute

Beverly Hills, California, United States

Arrowhead Regional Medical Center

Colton, California, United States

SCTI Research Foundation

Coronado, California, United States

eStudy Site

La Mesa, California, United States

Peter J. Ruane, M.D. Inc.

Los Angeles, California, United States

eStudySite

Oceanside, California, United States

University of California, Davis - Health System

Sacramento, California, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

January 1, 2013

Completion Date

April 1, 2013

Last Updated

April 2, 2014

Enrollment

527

ACTUAL participants

Conditions

Hepatitis C

Interventions

Sofosbuvir

DRUG

PEG

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: April 2, 2014Data 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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Phase 3 Study of Sofosbuvir and Ribavirin

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

Persuasive Health Communication Intervention for HIV/HCV

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