A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)

Roche

Status and phase: Withdrawn; Phase 3

Conditions: Hepatitis C, Chronic

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01296971

ML25246

Details and patient eligibility

About

This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Chronic hepatitis C
• Measurable serum HVC RNA levels
• Compensated liver disease (Child-Pugh class A)
• Treatment-naive for standard or pegylated interferons, or non-responder or relapsing

Exclusion criteria

• Concomitant hepatitis A or B
• History of chronic liver disease not caused by hepatitis C virus
• Hepatocellular carcinoma
• History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
• Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
• Pregnant or lactating women, or men whose partners are pregnant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

A

Experimental group

Description:

genotype 1, treatment-naive

Treatment:

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]

B

Experimental group

Description:

genotype 2 and 3, treatment-naive

Treatment:

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]

C

Experimental group

Description:

all genotypes, non-responders or relapses

Treatment:

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]