A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

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

NCT00087568

ML16965

Details and patient eligibility

About

This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients at least 18 years of age
• CHC infection, genotype 1
• unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
• use of 2 forms of contraception during the study in both men and women

Exclusion criteria

• women who are pregnant or breast-feeding
• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
• patients with decompensated cirrhosis
• patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Non-Responders

Experimental group

Description:

Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks.

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Non-Tolerators

Experimental group

Description:

Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (\< or \>=75 kg body weight, respectively) orally in divided doses for 36 weeks.

Treatment:

Drug: Ribavirin

Drug: peginterferon alfa-2a [Pegasys]