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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01011205
Eligibility Criteria:
Inclusion Criteria:
* Undergoing orthotopic liver or split liver allograft transplantation
* Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study
Exclusion Criteria:
* Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)
* Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
* Receiving ABO incompatible graft or a graft from a non heart beating donor
* Ongoing dosing with systemic corticosteroids
* Subjects with systemic infection requiring treatment except viral hepatitis
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:
* \< 3 nodes
* no node larger than 5 cm
* no metastases
* no vascular tumoral invasion
* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Subject or donor known to be HIV positive
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients
* Pregnant woman or breast-feeding mother
* Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
* Unlikely to comply with the Visits scheduled in the protocol
* Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator
* Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment
* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01011205
Study Brief:
Protocol Section:
NCT01011205