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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087646

MV17150

Details and patient eligibility

About

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.

Enrollment: 948 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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948 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

2

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

3

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

4

Active Comparator group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Drug: Ribavirin