Enteric Coated Myfortic for Liver Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167492
Recruitment Status : Withdrawn
First Posted : September 14, 2005
Last Update Posted : December 9, 2013
Information provided by:
The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to replace the mycophenolate mofetil (Cellcept) which is our usual therapy after liver transplantation with sodium mycophenolic acid (Myfortic®) and to find out the effect this change may have on the development of side effects such as relief of gastrointestinal (stomach) problems. In the past we have had to stop Cellcept (our current drug) because of these side effects. We will also try to see if improved usage of this drug (Myfortic®) will allow us to use lower doses of other medications that lower your immune system. We will do some special tests on your blood to see if the amount of the drug is related with its effect on the immune system and side effects. Both Cellcept and Myfortic® are FDA approved medications although Myfortic® is not approved for use after liver transplantation. Myfortic® is really the same active drug as Cellcept® (Mycophenolic acid) but has been coated to prevent breakdown of the drug in the stomach and is made to lower the known gastrointestinal effects of Cellcept such as diarrhea, abdominal pain and nausea.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Myfortic Phase 4

Detailed Description:

Mycophenolic Acid (MPA) has been shown to be an effective immune suppressant in organ transplantation. Its gastrointestinal side effects, however, have limited its use in liver transplantation (OLT). A new form of MPA that is enteric coated (Myfortic) has been developed to address the issue of GI side effects. While considerable experience has been gained with this new formulation in kidney transplants (ref) the information regarding the use of Myfortic in OLT recipients is limited. The purpose of the study is to assess the safety and efficacy of Myfortic in OLT recipients. The study will include a close follow-up of the patients with regard to side effects and potential adverse effects of the drug. It will also monitor the rate of compliance with this medication among the patients in the study. The efficacy of the drug will be determined by the rate of rejection but also and more importantly by our ability to withdraw corticosteroids and minimize calcineurin inhibitors (CNI).

Several tests will be conducted as part of the study. Some of those are "Standard of Care" tests such as liver function tests and complete blood cell count (CBC). Some tests however, will be performed specifically for this study. These include a patient questionnaire to be filled at various time points and blood tests designed to assess the integrity of the immune system.

The benefit to the patients is three-fold:

The patients will receive the medication free of charge for the duration of the study.

The proven efficacy of MPA as an immune suppressant may allow us to reduce or eliminate the use of corticosteroids and/or CNI whose long and short-term side effects are major causes of morbidity in OLT recipients.

Avoidance of the GI side effects of non-enteric coated MPA, which is our standard drug in OLT.

The risks for the patient include the potential deleterious side effects of MPA, namely bone marrow depression, GI side-effects (nausea, diarrhea, abdominal pain), and infections.

The general benefits from the study may be the addition of a better formulation of MPA to the list of drugs used for immunosuppression in OLT. Additionally, routine use of this drug may minimize the long-term adverse effects of CNI and corticosteroids thus improving long-term patient survival and well-being.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enteric Coated Mycophenolic Acid (Myfortic) in Liver Transplant Recipients- Effect on Compliance and Calcineurin Inhibitor and Corticosteroid Sparing
Study Start Date : September 2005
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Intervention Details:
    Drug: Myfortic
    720 mg by mouth every 12 hours

Primary Outcome Measures :
  1. Rate of rejection [ Time Frame: 6 months ]
  2. Rate of gastrointestinal side-effects [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Levels of calcineurin inhibitors [ Time Frame: 6 months ]
  2. Renal function [ Time Frame: 6 months ]
  3. Relationship of dose to biologic monitoring of immunosuppression [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Liver transplant recipients
  • Age: 18-70
  • Capable of oral intake

Exclusion Criteria:

  • Hepatitis C Cirrhosis
  • Hepatocellular Carcinoma T3
  • Liver retransplantation
  • Pregnancy
  • Platelet count <40,000
  • White Blood Cell count (WBC) <3,000
  • Incapable of oral intake
  • More than 30 days post op

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00167492

United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Bob Saggi, MD The University of Texas Health Science Center, Houston

Responsible Party: Dr. Bob Saggi, Memorial Hermann Hospital Identifier: NCT00167492     History of Changes
Other Study ID Numbers: HSC-MS-05-0197
Novartis Pharmaceuticals
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Mycophenolic Acid
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action