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

NCT00249860 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2013-08-06

No results posted yet for this study

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).

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 & Collaborators

  • Merck Pte. Ltd., Singapore

    collaborator INDUSTRY

  • EMD Serono

    lead INDUSTRY

Principal Investigators

  • Theodor Wee, M.D. · Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2005-08-31
Completion
2005-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00249860 on ClinicalTrials.gov