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 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT02739412
Eligibility Criteria:
Inclusion criteria:
1. Adult liver transplant recipients 2-4 years post transplantation
2. Male or female adult, age 18 - 65 years
3. Stable dosage of suppressant therapy for 1 month prior to study.
Exclusion criteria:
1. Recipient of multiple transplants (including solid organ, stem-cell, and bone marrow)
2. Serum liver panel (ALT, AST, Alkaline Phosphatase and Total Bilirubin) \> 2 x ULN,
3. Serum creatinine \> 1.5 x ULN,
4. eGFR of \< 40 ml/min,
5. Detectable hepatitis viral load,
6. Abnormal ECG with clinically significant findings per study physician's judgement,
7. Active infection,
8. Presence or history of autoimmunity disorders,
9. Evidence of allograft rejection,
10. Liver biopsy or fibroscan evidence of advanced stage liver fibrosis (\> Stage 2 Fibrosis),
11. Presence or history of cardiac or pulmonary disease,
12. Pregnant or nursing (lactating) women,
13. Health condition precludes participation in trial at study physician's judgment,
14. Inability to give consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02739412
Study Brief:
Protocol Section:
NCT02739412