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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT02732405
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent form signed,
2. Age \> 18 years,
3. Chronic infection with Hepatitis C virus genotype 1b,
4. HCV RNA \> 100 IU/mL,
5. HCV patients previously treated by PR with no response or previously treated with first generation PIs (boceprevir, telaprevir, simeprevir) and failing therapy,
6. Subjects with compensated cirrhosis with Child-Pugh score ranging between A5 to A6. Cirrhosis defined by liver biopsy (METAVIR F4) or non-invasive methods (transient elastography (FibroScan) \> 12.5 KPa; or FibroTest or FibroSure \> 0.75 with APRI \>2),
7. Hepatic Venous Pressure Gradient (HVPG) \> 6 mmHg (only in selected sites),
8. Albumin level ≥ 3.0 g/dl,
9. Platelet count ≥ 75 x 103/μL.
Exclusion Criteria:
1. Child-Pugh score greater than CP-A6,
2. Patients with HCV genotype 1a, 2, 3, 4, 5, 6,
3. Have any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance,
4. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive),
5. Decompensated cirrhosis/previous decompensation,
6. Pregnancy,
7. Breast-feeding,
8. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components,
9. Albumin level \< 3.0 g/dl,
10. Platelet count \< 75 x 103/μl,
11. Concomitant participation in any clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02732405
Study Brief:
Protocol Section:
NCT02732405