Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

Completed · Phase 3

Conditions studied: Hepatitis C Virus

In brief

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Key facts

Study ID

NCT01598090

Run by

Bristol-Myers Squibb

People needed

881

Starts

2012-06-14

Expected to finish

2015-05-15

Last updated by the study team

2019-07-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
• Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
• Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%
• HCV RNA ≥ 100,000 IU/mL
• Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
• Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
• Men or women, 18-70 years of age

You may not qualify if…

• Chronic liver disease due to causes other than chronic HCV
• Current or past evidence of decompensation
• Conditions that preclude the use of Alfa/RBV/TVR per respective labels
• Diagnosed or suspected hepatocellular carcinoma

Where it is running

• The Kirklin Clinic — Birmingham, Alabama, United States
• The University Of Alabama Of Birmingham — Birmingham, Alabama, United States
• Anaheim Clinical Trials Llc — Anaheim, California, United States
• Sc Clinical Research, Inc. — Garden Grove, California, United States
• Va Long Beach Healthcare System — Long Beach, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Va Greater Los Angeles Healthcare System — Los Angeles, California, United States
• University Of California, San Francisco/Sf General Hospital — San Francisco, California, United States
• South Bay Ge Medical Group — Torrance, California, United States
• Orlando Va Medical Center — Orlando, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Infectious Disease Research Institute, Inc. — Tampa, Florida, United States
• Gastrointestinal Specialists Of Georgia Pc — Marietta, Georgia, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Saint Luke'S Transplant Specialists — Kansas City, Missouri, United States
• Saint Louis University — St Louis, Missouri, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Options Health Research, Llc — Tulsa, Oklahoma, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• Gastro One — Germantown, Tennessee, United States
• Texas Clinical Research Institute — Arlington, Texas, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Clinical Research Centers Of America — Murray, Utah, United States
• Birmingham Gastroenterology Associates, P.C. — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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