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 @ 10:04 PM
Ignite Modification Date:
2025-12-24 @ 10:04 PM
NCT ID:
NCT01128335
Eligibility Criteria:
Inclusion criteria:
* Recipients of any race, 18 years or older
* Recipients of primary de novo orthotopic liver transplant from a deceased donor
* Recipients of a kidney with a cold ischemia time \< 30 hours
* HCV-negative recipients
Exclusion criteria:
* Prior organ/cellular transplant or multiple organ transplant
* MELD-score \> 35
* HCC \> Milan criteria
* Donor age \< 12 years
* Cold ischemia \> 15 hours
* Patients who are treated with drugs that are strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) or drugs with QT-prolonging properties
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01128335
Study Brief:
Protocol Section:
NCT01128335