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:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT00097435
Eligibility Criteria:
Major Inclusion Criteria:
* Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
* Have previously failed to respond to treatment with any interferon alfa (IFNa) product
* Have compensated liver disease with the following minimum criteria: white blood cell count \> 3,000/mm3, absolute neutrophil count (ANC) \> 2,000/mm3, platelets \> 125,000/mm3, and hemoglobin (Hb) \> 13 g/dL for males or \> 12 g/dL for females.
Major Exclusion Criteria:
* Evidence of decompensated cirrhosis or portal hypertension.
* Pregnant or lactating female.
* History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
* A current drug or alcohol addiction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00097435
Study Brief:
Protocol Section:
NCT00097435