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

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