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NCT01487577 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention
A Phase 2 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01487577 is a Phase 2 study that has completed, run by University of Pittsburgh. The registered enrollment target is 19 participants.
The verdict
NCT01487577, a Phase 2 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia, lymphoma, and other childhood cancers that were once considered incurable. A major barrier to the application of this life-saving treatment is acute graft-versus-host disease (GVHD) which develops in approximately 30-80% of patients and is a leading cause of death from transplant complications. Current GVHD prevention methods are not very efficacious and lead to unacceptable side effects. Mycophenolate mofetil (MMF), an anti-rejection medication used in solid organ transplants, has shown great promise in BMT recipients. The effectiveness of MMF depends on blood levels of mycophenolic acid (MPA, the active form of MMF). Different patients have been found to have different blood levels of MPA when they are given the same dose of MMF. The purpose of this study is to study a novel method of giving MMF based on its metabolism (pharmacokinetics) to achieve desired blood levels of MPA for prevention of GVHD. Non-invasive ways of monitoring the drug exposure will also be studied. The ultimate goal of this study is to improve approaches to GVHD prevention and improve outcomes of BMT in children.
Interventions
- DRUG Mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2010-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01487577
The ClinicalTrials.gov registry entry for NCT01487577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mycophenolate mofetil is the first listed.
NCT01487577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01487577 about?
NCT01487577 is a clinical study titled "Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention". Bone marrow transplantation (BMT) is used to successfully treat high-risk forms of leukemia, lymphoma, and other childhood cancers that were once considered incurable. A major barrier to the application of this life-saving treatment is acute graft-versus-host disease (GVHD) which develops in approxi...
What is the current status of trial NCT01487577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2010-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01487577?
The interventions under investigation include: Mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT01487577?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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