A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C

Phase 4

Completed

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

• Registration Number: NCT00940420
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2695

Inclusion Criteria

• adult patients >/= 18 years of age
• serologic evidence of chronic hepatitis C infection
• compensated liver disease
• negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment

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Exclusion Criteria

• history or other evidence of a medical condition associated with chronic liver disease other than HCV
• hepatitis A, hepatitis B or HIV infection
• hepatocellular carcinoma
• severe concomitant disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	peginterferon alfa-2a [Pegasys]	-
B	peginterferon alfa-2a [Pegasys]	-
A	Copegus (ribavirin)	-
B	Copegus (ribavirin)	-

Primary Outcome Measures

Name	Time	Method
safety and tolerability with regard to clinical AEs and laboratory parameters	assessed every 2 weeks throughout study and after 8 weeks follow-up

Secondary Outcome Measures

Name	Time	Method
safety with regard to hematological parameters	assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up