Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C Virus (HCV)

In brief

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Key facts

Study ID

NCT01616524

Run by

Bristol-Myers Squibb

People needed

880

Starts

2012-07-01

Expected to finish

2014-09-01

Last updated by the study team

2015-10-09

Who can join

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

You may qualify if…

• Chronic hepatitis C, Genotype 2 or 3
• Naïve to prior anti-HCV therapy

You may not qualify if…

• Infected with HCV other than Genotype 2 or 3
• Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
• Evidence of liver disease other than HCV
• Active substance abuse
• Evidence of decompensated cirrhosis

Where it is running

• Precision Research Institute, Llc — San Diego, California, United States
• Medical Associates Research Group — San Diego, California, United States
• University Of California, San Francisco/Sf General Hospital — San Francisco, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Orlando Infectious Disease Center — Orlando, Florida, United States
• Gastrointestinal Specialists Of Georgia — Marietta, Georgia, United States
• The Queen'S Liver Center — Honolulu, Hawaii, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Consultants For Clinical Research — Cincinnati, Ohio, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• University Of Pittsburgh Medical Center, Ctr For Liver Diseases — Pittsburgh, Pennsylvania, United States
• Texas Clinical Research Institute, Llc — Arlington, Texas, United States
• St. Luke'S Episcopal Hospital - Baylor College Of Medicine — Houston, Texas, United States
• Clinical Research Centers Of America — Murray, Utah, United States
• Local Institution — Autonoma, Buenos Aires, Argentina
• Local Institution — Buenos Aires, Buenos Aires, Argentina
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Ciudad de Buenos Aires, Buenos Aires, Argentina
• Local Institution — Mar del Plata, Buenos Aires, Argentina
• Local Institution — Quilmes, Buenos Aires, Argentina
• Local Institution — Córdoba, Córdoba Province, Argentina
• Mayo Clinic Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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