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

NCT ID: NCT00249860

Last Updated: 2013-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2005-08-31

Brief 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

Keywords

Subjects with chronic hepatitis C who have never previously received interferon therapy.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Interferon-beta-1a

Group Type: EXPERIMENTAL

Interferon-beta-1a

Intervention Type: DRUG

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

Ribavarin plus interferon-beta-1a

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

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

Ribavirin plus Interferon-beta-1a

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• Have an elevated serum alanine aminotransferase (ALT) between 1.5 and 10 times the upper limit of normal
• Had adequate bone marrow reserve and organ function
• Are not pregnant and are willing to use contraception, if, of childbearing potential
• Are willing and able to comply with the protocol and to give written informed consent

Exclusion Criteria

• Clinical evidence of liver cirrhosis or a diagnosis of definite cirrhosis on liver biopsy
• History of liver failure, severe retinopathy, immunologically mediated disease, cancer or epilepsy with a history of inadequately controlled seizures
• Any cause for the liver disease other than chronic hepatitis C
• Evidence of chronic renal impairment, liver cancer, unstable psychiatric disorder, known or ongoing alcohol or drug abuse
• Positive test at screening for Hepatitis B surface antigen, immunoglobulin M Hepatitis B core antibody and human immunodeficiency virus antibody
• Previous systemic treatment for Hepatitis C with an interferon or ribavirin
• Presence of systemic disease that might interfere with subject safety, compliance or evaluation
• Known allergies to acetaminophen, human serum albumin or mannitol;
• Glucocorticosteroids or other immunosuppressive drugs taken within 28 days of starting treatment
• Bearing organ transplants (except cornea)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Pte. Ltd., Singapore

INDUSTRY

Sponsor Role: collaborator

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Theodor Wee, M.D.

Role: STUDY_DIRECTOR

Serono Singapore Ltd, an affiliate of Merck Serono SA, Singapore

References

Chan HL, Ren H, Chow WC, Wee T; Interferon beta-1a Hepatitis C Study Group. Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C. Hepatology. 2007 Aug;46(2):315-23. doi: 10.1002/hep.21683.

Reference Type: RESULT

PMID: 17654600 (View on PubMed)

Related Links

http://www.mslifelines.com

Full FDA approved prescribing information can be found here

Other Identifiers

23744

Identifier Type: -

Identifier Source: org_study_id