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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT01429792
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
* Documented pre-treatment HCV RNA quantitative result
* Compensated liver disease (Child-Pugh Grade A)
* Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
Exclusion Criteria:
* Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
* Co-infection with active hepatitis A and/or hepatitis B
* History or evidence of a medical condition associated with liver disease other than HCV
* Signs and symptoms of hepatocellular carcinoma
* History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
* Therapy with antineoplastic treatment \</= 6 months prior to study day
* Diabetes mellitus in subjects receiving an insulin therapy
* Evidence of severe retinopathy
* Pregnant or breast-feeding women, and male partners of women who are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01429792
Study Brief:
Protocol Section:
NCT01429792