A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

Completed · Phase 3

Conditions studied: Hepatitis C, Chronic

In brief

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Key facts

Study ID

NCT00623428

Run by

Hoffmann-La Roche

People needed

235

Starts

2008-06-01

Expected to finish

2012-05-01

Last updated by the study team

2013-07-22

Who can join

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

You may qualify if…

• adult patients, >=18 years of age;
• serological evidence of chronic hepatitis C (CHC);
• CHC genotype 2 or 3;
• receiving PEGASYS + Copegus according to local standard of care and no rapid viral response (RVR);
• compensated liver disease.

You may not qualify if…

• pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of current therapy with PEGASYS + Copegus;
• coinfection with hepatitis A or B, or human immunodeficiency virus (HIV);
• history or other evidence of decompensated liver disease.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Lancaster, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Jacksonville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Opelousas, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Tupelo, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Egg Harbour Township, New Jersey, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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