Status:
COMPLETED
A Multicenter Phase 3 Study of Interferon-beta-1a for the Treatment of Chronic Hepatitis C in Asian Subjects
Lead Sponsor:
EMD Serono
Collaborating Sponsors:
Merck Pte. Ltd., Singapore
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00249860
Start Date
September 1 2002
End Date
August 1 2005
Last Update
August 6 2013
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