Status:
TERMINATED
Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Liver Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To determine whether long-term maintenance therapy with a single drug (Myfortic) applied using advanced immunologic monitoring tools in selected patients can lead to superior native kidney function at...
Detailed Description
The hypothesis to be tested is that donor-microchimerism in specific cell populations promotes the development of donor-specific regulation which in turn allows for long-term maintenance therapy with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01230502
Start Date
November 1 2011
End Date
June 1 2012
Last Update
May 7 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin- Madison
Madison, Wisconsin, United States, 53792