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 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT00336895
Eligibility Criteria:
Inclusion Criteria:
* ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age
* Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen
* Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia)
* Patients must be more than 30 days post-transplant to be eligible
* Females of childbearing potential must have a negative serum pregnancy test prior to the inclusion period
Exclusion Criteria:
* Multi-organ transplant patients
* HIV positive patients.
* Living-related liver transplant recipients
* Pregnant patients
* Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
* Patients with thrombocytopenia (\<50,000/mm3), with an absolute neutrophil count of \<1,000/mm3 and/or leukocytopenia (\<2,000/mm3), and/or hemoglobin \<7.0 g/dL prior to enrollment
* Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease)
* Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus
* Evidence of drug and/or alcohol abuse
* Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00336895
Study Brief:
Protocol Section:
NCT00336895