Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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 2 years without resulting in increased acute rejection episodes or deterioration of liver allograft function.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Novartis Pharmaceuticals
• Treatments: Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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