Trial | NCT00249860  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    257
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 Started
Sep 30
2002
Primary Completion
Aug 31
2005
Study Completion
Aug 31
2005
Last Update
Aug 06
2013
Estimate

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

Interferon-beta-1a Experimental

Ribavarin plus interferon-beta-1a Active Comparator

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
Other protocol defined inclusion criteria may apply

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)
Other protocol defined exclusion criteria may apply
No Results Posted