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Enteric Coated Myfortic for Liver Transplant Recipients

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Novartis
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00167492
First received: September 9, 2005
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Liver Transplantation
Drug: Myfortic
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Rate of rejection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Rate of gastrointestinal side-effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Levels of calcineurin inhibitors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Renal function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Relationship of dose to biologic monitoring of immunosuppression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Myfortic
    720 mg by mouth every 12 hours
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167492

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

No publications provided

Responsible Party: Dr. Bob Saggi, Memorial Hermann Hospital
ClinicalTrials.gov Identifier: NCT00167492     History of Changes
Other Study ID Numbers: HSC-MS-05-0197, Novartis Pharmaceuticals, CERL080A-US11
Study First Received: September 9, 2005
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014