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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02902120
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age at the time of screening
* Have stable renal function for one month (30 days) prior to enrollment
* Have Chronic HCV infection prior to transplantation with documented HCV viremia ≥ 1,000 IU/ml at screening and either documented HCV Ab positivity or HCV viremia ≥ 1,000 IU/ml at least 6 months prior to enrollment.
* Documented genotype 1 HCV infection prior to enrollment and after their transplant in the post-transplantation cohort
* HCV disease staging within 12 months prior to enrollment by liver biopsy, transient elastography, or biochemical testing
* Be able to give informed consent and comply with study guidelines
* Women of childbearing age will be required to have a negative pregnancy test at enrollment and use birth control throughout the duration of treatment.
Inclusion Criteria Specific to the Pre-transplant Arm
Patients will either be:
* On the transplant waiting list followed by the University of Maryland's nephrology clinic or the Baltimore VA's nephrology clinic
* On chronic hemodialysis not yet on the transplant list and followed in the University's hemodialysis center or in the University's nephrology clinic
* Have chronic kidney disease with GFR \<50
Inclusion Criteria Specific to the Post-transplant Arm
• Patients will have undergone renal transplantation no greater than five years prior to enrollment and will be followed in our University's nephrology and infectious disease clinic. They will all have stable renal function at the time of enrollment.
Exclusion Criteria:
* Documented positive hepatitis B (HBV) surface antigen, and/or HBV DNA prior to enrollment
* Any prior exposure to HCV protease inhibitor therapy
* HIV co-infection if on a protease inhibitor based regimen
* Increase in creatinine of 15% or greater within one month (30 days) of the screening visit
* Evidence of hepatocellular carcinoma at the time of enrollment
* Liver disease caused by an etiology other than HCV
* F4 or decompensated cirrhotic patients
* Child Pugh class B or C
* AST or ALT \>350 within 6 months prior to enrollment
* Albumin \< 3g/dL at the time of enrollment
* Platelet count \< 75 at the time of enrollment
* History of clinically significant allergy or adverse event with protease inhibitors
* Evidence of the acquisition of HCV at the time of or after transplantation
* Pregnant or breastfeeding women
* Cyclosporine; St. John's Wort; Efavirenz; Phenytoin; Carbamazepine; Bosentan; HIV protease inhibitors; modafinil; ketoconazole; or rifampin use within 7 days of enrollment
* Coadministration of more than 20 mg atorvastatin; 10 mg rosuvastatin; 20 mg of fluvastatin, lovastatin or simvastatin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02902120
Study Brief:
Protocol Section:
NCT02902120