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

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono
• Collaborator: Merck Pte. Ltd., Singapore
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Ribavirin

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