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 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT03987503
Eligibility Criteria:
Inclusion Criteria:
* ≥18 years of age
* anti-HCV and HCV RNA positive,
* Lifetime injection drug use or blood transfusion before 1991
* interested in starting HCV treatment at the time of diagnosis
* Women of childbearing potential engaged in sexual activity that could lead to pregnancy
* must consent to use contraception and agree to pregnancy testing during treatment
* If currently not enrolled in insurance, agree to assistance to enroll in insurance
Exclusion Criteria:
* HBsAg positive from pre-screening visit and no medically controlled hepatitis B virus (HBV) condition
* History of hepatic decompensation (ascites, hepatic encephalopathy, or variceal hemorrhage).
* Current use of medications that is not compatible with SOF/VEL use, according to current prescribing guidelines, including amiodarone or a proton pump inhibitor exceeding 20 mg of omeprazole equivalent.
* Prior treatment with an NS5a based HCV treatment regimen with subsequent viral rebound. Participants who have clear HCV reinfection as defined by an HCV GT that is different from the original genotype may enroll. If genotype results are not available from the initial and subsequent HCV infection, the individual will not be enrolled unless participant can provide SVR-12 record confirming HCV cure.
* Pregnancy or breastfeeding.
* Life expectancy of \< 12 months as assessed by study clinical health provider.
* Late exclusion criteria: Participants with the following lab values at week 0 will be evaluated on a case by case basis for continuation of SOF/VEL at the week 2 visit
* Albumin \< 3.0
* Hemoglobin \< 8.0 (women) and \< 9.0 g/dl ( men)
* Platelet count \< 50,000
* creatinine (Cr) clearance (estimated by Cockcroft-Gault) \< 30 ml/min
* aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 10 x ULN
* Total bilirubin \> 1.5x ULN (for participants on atazanavir, \> 3 x ULN), international normalized ratio (INR) \> 1. 5 x ULN
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03987503
Study Brief:
Protocol Section:
NCT03987503