Overview

A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
Participant gender:
Summary
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic Hepatitis C with better efficacy and safety profiles in monotherapy or combination therapy. This will be a multicenter, randomized, double-blind, placebo-controlled study with a placebo to be crossed-over to a combination of interferon-beta-1a and ribavirin or no treatment during an open-label extension phase. The duration of the trial will be 48 weeks, with a double-blind period of 12 weeks. The study will recruit 257 eligible subjects of either sex. It will be conducted by approximately 16 Investigators / investigational centers in 3 countries (China, Hong Kong and Singapore).
Phase:
Phase 3
Details
Lead Sponsor:
EMD Serono
Collaborator:
Merck Pte. Ltd., Singapore
Treatments:
Interferon beta-1a
Interferon-beta
Interferons
Ribavirin