Enteric Coated Myfortic for Liver Transplant Recipients
Enteric Coated Mycophenolic Acid (Myfortic) in Liver Transplant Recipients- Effect on Compliance and Calcineurin Inhibitor and Corticosteroid Sparing
3 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedDecember 9, 2013
December 1, 2013
3.4 years
September 9, 2005
December 5, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Rate of rejection
6 months
Rate of gastrointestinal side-effects
6 months
Secondary Outcomes (3)
Levels of calcineurin inhibitors
6 months
Renal function
6 months
Relationship of dose to biologic monitoring of immunosuppression
6 months
Interventions
720 mg by mouth every 12 hours
Eligibility Criteria
You may qualify if:
- Liver transplant recipients
- Age: 18-70
- Capable of oral intake
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center, Houstonlead
- Novartiscollaborator
Study Sites (1)
Memorial Hermann Hospital
Houston, Texas, 77030, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bob Saggi, MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
September 1, 2005
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
December 9, 2013
Record last verified: 2013-12