Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection

Completed · Phase 3

Conditions studied: Chronic Hepatitis C

In brief

This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Key facts

Study ID

NCT01641640

Run by

Gilead Sciences

People needed

328

Starts

2012-06-01

Expected to finish

2013-04-01

Last updated by the study team

2014-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infection with HCV genotype 1, 4, 5, or 6
• Cirrhosis determination
• Subject met the following classifications:
• Treatment-naive
• Screening laboratory values within defined thresholds
• Not treated with any investigational drug or device within 30 days of screening
• Use of highly effective contraception methods if female of childbearing potential or sexually active male

You may not qualify if…

• Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
• Pregnant or nursing female, or male with pregnant female partner
• Current or prior history of clinical hepatic decompensation
• History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
• Excessive alcohol ingestion or significant drug abuse

Where it is running

• SCTI Research Foundation — Coronado, California, United States
• Kaiser Permanente — Los Angeles, California, United States
• Peter J. Ruane, MD, Inc. — Los Angeles, California, United States
• Anthony Mills MD, Inc. — Los Angeles, California, United States
• University of California San Diego — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Kaiser Permanente — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• South Denver Gastroenterology, PC — Englewood, Colorado, United States
• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• Capital Medical Associates — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Borland-Groover Clinic Baptist — Jacksonville, Florida, United States
• University of Miami Center for Liver Diseases — Miami, Florida, United States
• Advanced Research Institute — New Port Richey, Florida, United States
• Orlando Immunology Center (ACH) — Orlando, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• South Florida Center of Gastroenterology, P.A. — Wellington, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Infectious Disease Specialist of Atlanta — Decatur, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Indianapolis Gastroenterology Research Foundation — Indianapolis, Indiana, United States
• Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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