A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: PEG-IFN alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00192647

ML17908

Details and patient eligibility

About

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.

Enrollment: 896 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic CHC, genotype 1
• Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
• Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
• Compensated liver disease
• Naive to interferon-based therapy for CHC infection

Exclusion criteria

• Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
• Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
• Chronic liver disease other than CHC infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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896 participants in 2 patient groups

PEG-IFN alfa-2a+Ribavirin - Induction Treatment

Experimental group

Description:

Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.

Treatment:

Drug: Ribavirin

Drug: PEG-IFN alfa-2a

PEG-IFN alfa-2a+Ribavirin - Standard Treatment

Experimental group

Description:

Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.

Treatment:

Drug: Ribavirin

Drug: PEG-IFN alfa-2a