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NCT00619216 · ClinicalTrials.gov registry record
Myfortic Conversion Trial in OLT Recipients With GI Intolerance
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 31
- Enrollment target
NCT00619216: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT00619216 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00619216 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
Study Summary
Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.
Interventions
- DRUG Mycophenolic Acid (Myfortic)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-12 |
What the finished NCT00619216 record still lists
NCT00619216 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Mycophenolic Acid (Myfortic) is the first listed.
NCT00619216 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00619216 about?
NCT00619216 is a clinical study titled "Myfortic Conversion Trial in OLT Recipients With GI Intolerance". Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of pati...
What is the current status of trial NCT00619216?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2008-03. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00619216?
The interventions under investigation include: Mycophenolic Acid (Myfortic) (DRUG).
Who is sponsoring clinical trial NCT00619216?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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