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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT01360268
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 y/o or older
2. Positive for the HCV antibody and HCV RNA detected
3. Patients with abnormal liver function OR a liver biopsy specimen taken in the 6 months prior to study entry showing chronic hepatitis, or liver fibrosis, or liver cihhrosis
4. Have not been previously treated with pegylated-interferon and ribavirin for HCV
5. Genotype 1 or Genotype 2
Exclusion Criteria:
1. Subjects with decompensated liver disease
2. With human immunodeficiency virus
3. With hepatitis B infection
4. With hemochromatosis defined by a pre-existing diagnosis of hemochromatosis or a positive HFE gene mutation or recipients of solid organ transplants
5. With clinically significant cardiac or cardiovascular abnormalities, organ grafts, systemic infections, clinically significant bleeding disorders, evidence of malignant neoplastic diseases
6. Subjects who are on lipid-lowering medications
7. Poorly controlled Diabetes (A1C \> 9%) -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01360268
Study Brief:
Protocol Section:
NCT01360268