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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00451932
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients at least 18 years of age and not older than 65 years.
* Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
* Male patients must agree to practice effective birth control methods during the study.
* Patient is a recipient of a primary whole cadaveric liver transplant
Exclusion Criteria:
* Patient has previously received or is receiving an organ transplant other than a liver.
* Patient has received an ABO incompatible donor liver.
* Patient or donor is known to be HIV positive.
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
* Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one \> 3.0 cm.
* Patient has a serum creatinine \>175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
* Patient who is receiving or may require warfarin or fluvastatin during the study.
* Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00451932
Study Brief:
Protocol Section:
NCT00451932