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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01760356
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers:
* Age: 18 to 70 years.
* Ethnicity: Hispanic, African American.
* Gender: male and female.
* Condition: healthy.
* Informed consent: granted and signed informed consent at the time of inclusion and agreement to comply with all the procedures included in the protocol.
Waiting List Patients:
* Age: 18 to 70 years.
* Ethnicity: Hispanic, African American.
* Gender: male and female.
* Being active on the waiting list for liver transplantation
* Informed consent: granted and signed at the time of inclusion and agreement to comply with all the procedures included in the protocol.
Transplant Patients:
* Age: 18 to 70 years.
* Ethnicity: Hispanic, African American.
* Gender: male and female.
* Drug therapy: cyclosporine or tacrolimus, with or without mycophenolic acid derivatives and/or corticosteroids.
* Informed consent: granted and signed at the time of inclusion and agreement to comply with all the procedures included in the protocol.
Exclusion Criteria:
Healthy volunteers:
* pregnancy
* breastfeeding
* chronic drug treatment
* non healthy
Waiting List Patients:
* Patients with previous transplant.
* Patients with more of one transplanted organ.
* Patients on anticalcineurin drugs.
* Patients with impaired renal function - creatinine clearance ≤ 20 ml/min.
Transplant Patients:
* Pregnant or breastfeeding.
* Patients with prior retransplantation.
* Patients with more of one transplanted organ.
* Patients with impaired renal function - creatinine clearance ≤ 20 ml/min.
* Everolimus indication at any time during treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01760356
Study Brief:
Protocol Section:
NCT01760356