A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• adult patients >=18 years of age;

• body weight >85kg (187lbs);

• CHC (genotype 1);

• liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;

• use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

• women who are pregnant or breastfeeding;

• male partners of women who are pregnant;

• conditions associated with decompensated liver disease;

• other forms of liver disease, including liver cancer;

• human immunodeficiency virus infection;

• previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.