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

Open-label, Multicenter, Non-Comparative Prospective Study to Assess the Safety of Individualized Combination Therapy With Ribavirin And Peginterferon Alfa-2a (40 kD) in Patients With Chronic Hepatitis C (CHC) (MASTER Study)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01296971

Enrollment

Registered

2011-02-16

Start date

2009-12-31

Completion date

2009-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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.

Interventions

DRUGpeginterferon alfa-2a [Pegasys]

180 mcg sc weekly

DRUGribavirin [Copegus]

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026