REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2003
End Date:May 2008

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A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

This 4 arm study is designed for patients with CHC who have not responded to peginterferon
alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening
the duration of treatment, as well as including an initial 12-week period of high-dose
PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS
(180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment
is 1-2 years and the target sample size is 500+ individuals.


Inclusion Criteria:

- adult patients >=18 years of age;

- CHC infection;

- 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;

- Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin
combination therapy given for >=12 weeks.

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.
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