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

Phase 3

Withdrawn

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

• Registration Number: NCT01296971
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-16
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	ribavirin [Copegus]	genotype 2 and 3, treatment-naive
A	peginterferon alfa-2a [Pegasys]	genotype 1, treatment-naive
A	ribavirin [Copegus]	genotype 1, treatment-naive
C	peginterferon alfa-2a [Pegasys]	all genotypes, non-responders or relapses
C	ribavirin [Copegus]	all genotypes, non-responders or relapses
B	peginterferon alfa-2a [Pegasys]	genotype 2 and 3, treatment-naive

Primary Outcome Measures

Name	Time	Method
Safety of individualized Copegus treatment in combination with Pegasys: Adverse events	up to 96 weeks
Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)	up to 96 weeks

Secondary Outcome Measures

Name	Time	Method
Virological response/sustained virological response (serum HCV RNA levels)	24 weeks after treatment completion