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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
257
Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24
Matching placebo will be administered subcutaneously three times a week for 12 weeks. The placebo responders will continue the study off-treatment after Week 12 up to Week 24
Placebo non-responders at Week 12 will receive ribavirin at a dose of 1000 milligram (mg) or 1200 mg orally once daily in combination with Interferon-beta-1a, administered subcutaneously at a dose of 44 mcg three times a week, from Week 16 up to Week 24
Percentage of subjects achieving sustained viral response (SVR) at Week 24
Time frame: Week 24
Percentage of subjects achieving sustained viral response (SVR) at Week 48
Time frame: Week 48
Change from baseline in viral load (Hepatitis C virus ribonucleic acid [HCV RNA]) at Week 12, 24, and 48
Time frame: Baseline, Week 12, 24, and 48
Percentage of subjects with Alanine transaminase (ALT) normalization
Time frame: Week 12, 24, and 48
Percentage of subjects with viral clearance
Time frame: Week 12 and 24
Percentage of subjects with both SVR and sustained ALT normalization
Time frame: Week 48
Number of subjects with improvement in the liver necroinflammation score by at least two points
Time frame: Week 48
Number of subjects with improvement in architectural staging (liver fibrosis) by at least one point
Time frame: Week 48
Number of subjects with adverse events and serious adverse events
Time frame: Baseline up to Week 48
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