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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 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 31 participants.

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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

FieldValue
Enrollment Target 31 participants
Start Date 2008-03
Est. Completion 2009-12

What the Registry Record Tells You About NCT00619216

The ClinicalTrials.gov registry entry for NCT00619216 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Mycophenolic Acid (Myfortic) is the first listed.

NCT00619216 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.