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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)

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug); ribavirin [Copegus] (Drug); ribavirin [Copegus] (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: 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)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety of individualized Copegus treatment in combination with Pegasys: Adverse events

Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA)

Secondary outcome: Virological response/sustained virological response (serum HCV RNA levels)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: December 2009
Last updated: August 17, 2015

Page last updated: August 23, 2015

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