Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT00249860
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00249860
Study Brief:
Protocol Section:
NCT00249860