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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394277

NV18210

Details and patient eligibility

About

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.

Enrollment: 1,175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,175 participants in 4 patient groups

PEG-IFN 180 µg + Ribavirin 1200 mg

Experimental group

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a

Drug: peginterferon alfa-2a

Drug: Ribavirin

PEG-IFN 180 µg + Ribavirin 1400/1600 mg

Experimental group

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a

Drug: peginterferon alfa-2a

Drug: Ribavirin

PEG-IFN 360/180 µg + Ribavirin 1200 mg

Experimental group

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a

Drug: peginterferon alfa-2a

Drug: Ribavirin

PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg

Experimental group

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a

Drug: peginterferon alfa-2a

Drug: Ribavirin