Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167492
Status:
WITHDRAWN
Last Update Posted:
2013-12-09
First Post:
2005-09-09
Brief Title:
Enteric Coated Myfortic for Liver Transplant Recipients
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Enteric Coated Mycophenolic Acid Myfortic in Liver Transplant Recipients- Effect on Compliance and Calcineurin Inhibitor and Corticosteroid Sparing
Status:
WITHDRAWN
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CERL080A-US11 | None | None | None |
| Novartis Pharmaceuticals | None | None | None |