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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03828058
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 years or older
4. Recipients of a first-time liver transplant
5. Serum Creatinine level less than 2.0 on Post-Operative Day 3-7
6. Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen
7. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Exclusion Criteria:
1. Any prior use of tacrolimus or cyclosporine
2. Recipients of prior organ transplant
3. Need for hemodialysis in the week preceding or following liver transplantation
4. Recipients of living donor liver or split deceased donor liver allografts
5. Recipients of combined liver/kidney transplants
6. Pregnancy or lactation
7. Recipients of ABO incompatible liver allografts
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03828058
Study Brief:
Protocol Section:
NCT03828058