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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT01230502
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, ages 18 years and older who have received a primary liver transplant from a deceased donor for end stage liver disease \*(ESLD).
* Women of child-bearing potential must have a negative serum pregnancy test at the time of screening and agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of study treatment.
Exclusion Criteria:
* Recipients of multi-organ transplants.
* Recipients with positive crossmatch with their donor (current or previously).
* Subjects with a screening white blood cell count ≤ 2,000 mm3 or absolute neutrophil count (ANC) ≤ 1000, platelet count ≤ 100,000 mm3.
* Recipients with a hematocrit \< 32.
* History of malignancy within 5 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
* Subjects who are positive for hepatitis C, hepatitis B surface antigen, or HIV.
* Subjects with previous intolerance to full dose MPA agent.
* Subjects with a history of acute rejection within 6 months prior to study enrollment.
* Subjects who have had chronic ductopenic rejection.
* Subjects who had rejection in the first-year post-transplant and are less than 3 years post-transplant.
* Subjects who had rejection requiring treatment with thymoglobulin or Orthoclone-OKT3 (OKT3) at anytime post-transplant.
* Original cause of ESLD related to autoimmune diseases such as autoimmune hepatitis, primary biliary cirrhosis, and primary sclerosing cholangitis.
* Subjects who have received an investigational drug within 4 weeks of study entry.
* Subjects with a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Female subjects who are pregnant or nursing or females who are unwilling to use contraception during the study.
* Subjects who are currently receiving any therapy for immunosuppression other than a MPA agent and tacrolimus.
* Subjects with a history of hepatocellular carcinoma (T2 \>).
* Subjects with severe coexisting disease or presenting with any unstable medical condition which could affect study objectives.
* Subjects who have a known hypersensitivity to tacrolimus or mycophenolate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01230502
Study Brief:
Protocol Section:
NCT01230502