A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Key facts

Study ID

NCT00394277

Run by

Hoffmann-La Roche

People needed

1175

Starts

2007-02-01

Expected to finish

2009-04-01

Last updated by the study team

2010-08-03

Who can join

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

You may qualify if…

• Adult patients, ≥18 years of age
• CHC infection, genotype 1
• Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
• Baseline body weight ≥85 kg
• Liver biopsy (within 24 months of first dose) with results consistent with CHC

You may not qualify if…

• Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
• Other forms of liver disease, including liver cancer
• Human immunodeficiency virus infection

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — Phoenix, Arizona, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Lancaster, 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 — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — San Marcos, California, United States
• Study site — Ventura, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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