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

PHASE3CompletedINTERVENTIONAL
Enrollment

257

Participants

Timeline

Start Date

September 30, 2002

Primary Completion Date

August 31, 2005

Study Completion Date

August 31, 2005

Conditions
Hepatitis C
Interventions
DRUG

Interferon-beta-1a

Interferon-beta-1a will be administered subcutaneously at a dose of 44 microgram (mcg), three times a week up to Week 24

DRUG

Placebo

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

DRUG

Ribavirin plus Interferon-beta-1a

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

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Merck Pte. Ltd., Singapore

INDUSTRY

lead

EMD Serono

INDUSTRY

NCT00249860 - A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects | Biotech Hunter | Biotech Hunter