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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00984620
Eligibility Criteria:
Inclusion criteria:
1. Chronic hepatitis C infection of genotype 1
2. Therapy-naïve to interferon, pegylated interferon, and ribavirin
3. HCV viral load \> 100.000 IU/ml at screening
4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
5. Normal retinal finding on fundoscopy within 6 months prior to Day 1
6. Age 18 to 70 years
Exclusion criteria:
1. HCV of mixed genotype (1/2, 1/3, and 1/4) .
2. Patients who have been previously treated with at least one dose of any protease inhibitor
3. Evidence of liver disease due to causes other than chronic HCV infection
4. Positive for HIV-1 or HIV-2 antibodies
5. Hepatitis B virus (HBV) infection
6. Decompensated liver disease, or history of decompensated liver disease
7. Active malignancy or history of malignancy within the last 5 years
8. History of alcohol or drug abuse (except cannabis) within the past 12 months.
9. Body Mass Index \< 18 or \> 35 kg/m2.
10. Usage of any investigational drugs within 30 days prior to enrolment
11. Alpha fetoprotein value \>100ng/mL at screening;
12. Total bilirubin \> 1.5 x ULN with ratio of direct/indirect \> 1.
13. ALT or AST level \> 10 x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00984620
Study Brief:
Protocol Section:
NCT00984620