Eligibility Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT03155906
Eligibility Criteria: Inclusion Criteria: * Receiving OST from included outpatient clinic * Chronically infected with HCV (HCV RNA positive and also HCV RNA positive or anti-HCV at least 6 months before inclusion) * Eligible for treatment according to national guidelines (criteria specified below) * Obtaining informed consent At the time of study initiation , eligibility for treatment according to national guidelines was defined as follows: * Genotype 1 and 4 independent of degree of fibrosis * Genotype 2 and 3, dependent on significant fibrosis. Significant fibrosis will be assessed with FibroScan indicating elastography of above 7 kPa. Where elastography cannot be obtained, significant fibrosis will be assessed with AST to platelet ratio index (APRI score) of \> 0.7 (http://www.hepatitisc.uw.edu/page/clinical-calculators/apri), i.e. APRI = ASAT levels (in IU/L) / 40 (upper normal levels of ASAT in IU/L) / platelet count (109/L). An APRI score greater than 0.7 had a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis. Exclusion Criteria: * Co-infection with HIV * Severe extrahepatic HCV associated diseases (e.g. cerebral vasculitis, cryoglobulinemia/membranoprolifereative glomerulonephritis (MPGN), renal failure (eGFR \<30), polyarthritis) * Decompensated liver failure assessed with Child-Pugh (CP) score (\>6 points, class B and C) * Currently receiving treatment for HCV
Healthy Volunteers: False
Sex: ALL
Study: NCT03155906
Study Brief:
Protocol Section: NCT03155906