A Multicentre Phase III Study of Interferon-Beta-1a for the Treatment of Chronic Hepatitis C in Asian Patients
The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic hepatitis C with better efficacy & safety profiles in monotherapy or combination therapy.
This will be a multicentre, randomised, double-blind, placebo-controlled study with a placebo cross-over to 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 250 eligible patients of either sex. It will be conducted by approximately 16 Investigators / investigational centres in 3 countries (China, Hong Kong and Singapore).
Drug: Recombinant human interferon-beta-1a (interferon-beta-1a; IFN-beta-1a), delivered in pre-filled syringes for subcutaneous injection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment