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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT00456235
Eligibility Criteria:
Inclusion Criteria:
* Patient with first liver transplantion or retransplantation since more than 6 months: with a post-transplant lapse of time of 2 to 10 years and showing one of the following adverse effects of ICN:
* Renal insufficiency defined by a creatinine clearance \<50ml/mn (calculated or estimated according to the Cockcroft formula)
* Arterial hypertension not controlled by an anti-hypertensive bitherapy
* Diabetes mellitus (fasting glycaemia \>7.0mmol/l), whether treated or not
* Neuromuscular toxicity
* Immunosuppression by cyclosporine or tacrolimus and MMF
* Hepatic biopsy performed within the 6 months preceding the inclusion for the patients with a post-transplant period of \<5 years and in the 12 months preceding the inclusion for patients with a post transplant period of \>5 years.
Exclusion Criteria:
* Acute rejection within the 6 months preceding the screening
* Previous history of cortico-resistant rejection
* Chronic rejection
* Significant ductopenia (absence of inter-lobule biliary canals in more than 30% of the portal tracts) on the pre-screening biopsy.
* Existence of a pre-transplantation diabetes mellitus.
* Liver transplantation for auto-immune hepatitis or primary sclerosing cholangitis
* Patients transplanted for viral C cirrhosis with reinfection lesions of the transplanted organ, rendering treatment by ribarivine + interferon conceivable in the year following inclusion.
* Counter-indications to MMF (anaemia, leucopenia)
* Immunosuppression by sirolimus, everolimus, azathioprine or corticoids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00456235
Study Brief:
Protocol Section:
NCT00456235