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

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 3

Conditions

Hepatitis C

Treatments

Drug: Placebo

Drug: Interferon-beta-1a

Drug: Ribavirin plus Interferon-beta-1a

Study type

Interventional

Funder types

Industry

Identifiers

NCT00249860

23744

Details and patient eligibility

About

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).

Enrollment

257 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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