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Enteric Coated Myfortic for Liver Transplant Recipients

NCT ID: NCT00167492

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Myfortic

720 mg by mouth every 12 hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Memorial Hermann Hospital

Principal Investigators

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Bob Saggi, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Memorial Hermann Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Novartis Pharmaceuticals

Identifier Type: -

Identifier Source: secondary_id

CERL080A-US11

Identifier Type: -

Identifier Source: secondary_id

HSC-MS-05-0197

Identifier Type: -

Identifier Source: org_study_id