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

NCT ID: NCT01296971

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

genotype 1, treatment-naive

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly

ribavirin [Copegus]

Intervention Type DRUG

1'000/1'200 mg daily orally, 24 - 72 weeks

B

genotype 2 and 3, treatment-naive

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly

ribavirin [Copegus]

Intervention Type DRUG

800 mg daily orally, 16 - 48 weeks

C

all genotypes, non-responders or relapses

Group Type EXPERIMENTAL

peginterferon alfa-2a [Pegasys]

Intervention Type DRUG

180 mcg sc weekly

ribavirin [Copegus]

Intervention Type DRUG

1'000/1'200 mg daily orally, 24 - 72 weeks

Interventions

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peginterferon alfa-2a [Pegasys]

180 mcg sc weekly

Intervention Type DRUG

ribavirin [Copegus]

1'000/1'200 mg daily orally, 24 - 72 weeks

Intervention Type DRUG

ribavirin [Copegus]

800 mg daily orally, 16 - 48 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

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ML25246

Identifier Type: -

Identifier Source: org_study_id