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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT02455167
Eligibility Criteria:
Inclusion Criteria:
1. HCV genotype 1 infection (all subtypes and Q80K a type of mutation are allowed), and have been approved by a third party payer for the FDA-approved combination of sofosbuvir (SOF) plus ribavirin. The study drug, simeprevir (SMV)
2. Biopsy proven cirrhosis, or clinical cirrhosis with APRI (AST to Platelet Ratio Index to determine clinical cirrhosis)\> 2, Fibrotest \> 0.75, or Fibroscan \> 12.5 Results Stiffness (kPa).
3. MELD 10 or less
4. Expected survival without liver transplantation of \>1 year
5. Patients with Hepatocellular carcinoma (HCC) are included as long as disease MELD is 10 or less, and anticipated time to transplant is \>1 year. An example, might be a patient with a subcentimeter HCC who is undergoing serial imaging to document tumor growth to tumor diameter \>2 cm prior to listing for transplantation (in order to secure MELD exception). In this case, there could be a time lapse of 3 months or more while monitoring tumor growth, and a further time lapse of 9 months or more until the time of transplantation.
6. Patients with TIPS or Portal Vein Thrombosis may be included. -
Exclusion Criteria:
1. Inability to provide informed consent
2. Known hypersensitivity or serious adverse reaction to any of the study drugs
3. Age \<18 or \>80 years
4. Pregnancy as determined by subject reporting and urine dipstick testing at screening.
5. Other underlying chronic liver disease - examples that would exclude a patient from participating include but are not limited to nonalcoholic liver disease, alcoholic liver disease, hepatitis B, hemochromatosis, and autoimmune liver disease.
6. Serious other underlying medical condition - examples include but are not limited to unstable cardiovascular, coronary, or pulmonary disease including right and left sided heart failure, active malignancy other than HCC, or serious infection.
7. Estimated creatinine clearance \< 30 mL min-1 1.73 m2 surface area (BSA)
8. Hemoglobin \<10 g/dL
9. Neutrophils \<500 /μL
10. Platelets \<50,000 /μL
11. Bilirubin \>4 mg/dL
12. Albumin \< 2.8 g/dL
13. Blood Clotting: International Normalised Ratio (INR) \> 2
14. MELD \>10
15. Child-Turcotte-Pugh class B or C; or, CTP score \>7
16. Conditions that would affect the absorption of orally administered cholate used in the HepQuant® test - such as, extensive intestinal resection, diabetic gastroparesis, and ileal disease or resection.
17. Concomitant use of both beta-blocker and ACE inhibitor
18. Subjects taking any other medications with significant drug drug interactions related to the study medications (sofosbuvir, simeprevir, or ribavirin) who cannot discontinue or substitute that medication, will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02455167
Study Brief:
Protocol Section:
NCT02455167