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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01824368
Eligibility Criteria:
Inclusion Criteria:
* Have been receiving liver transplant two years ago.
* Be 18 years or older.
* Treatment with immunosuppression including cyclosporine or tacrolimus.
* Having a normal liver function in the last year
* Not have suffered acute rejection in the last year and have no chronic rejection
* Submit any significant side effects from medication immunosuppressive (hypertension, creatinine greater than 1.7 mgDl, diabetes, morbid obesity, osteoporosis, hyperlipidemia, severe hirsutism, neurotoxicity novo malignancy, etc.)
* Etiology of underlying disease: alcoholic cirrhosis with or without hepatocarcinoma, metabolic diseases, amyloidotic polyneuropathy family, biliary atresia, fulminant hepatitis non-A, non-B, non-C, cirrhosis cryptogenic and generally causes no viral or autoimmune.
* Patients offering sufficient guarantees of adherence to protocol
* Patients who give written informed consent for participate in the study.
* It is necessary that the patient meets all inclusion criteria.
Exclusion Criteria:
* Underlying disease of the autoimmune (primary sclerosing cholangitis, autoimmune cirrhosis, primary biliary cirrhosis) or epatocarcinoma about cirrhosis of viral or autoimmune.
* Patients with chronic rejection, or acute rejection in the last year.
* Patients with liver retransplantation.
* patients with history of hypersensitivity or idiosyncratic reactions to methoxsalen, psoralen the compounds or any of the excipients.
* patients with melanoma, cutaneous basal cell carcinoma or squamous cell coexistent.
* Patients with aphakia.
* Patients taking Oxoralen.
* Pregnant women or nursing mothers, or adults of childbearing age not using effective contraception.
* Participation in another clinical trial.
* Inability to understand informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01824368
Study Brief:
Protocol Section:
NCT01824368