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NCT01665677 · ClinicalTrials.gov registry record · Phase 2
Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation
A Phase 2 study, sponsored by Mehdi Hamadani.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT01665677 is a Phase 2 study that has completed, run by Mehdi Hamadani. The registered enrollment target is 69 participants.
The verdict
NCT01665677, a Phase 2 study, has completed, sponsored by Mehdi Hamadani.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
Hematopoietic stem cell transplantation is a procedure in which a person receives blood forming stem cells from a person called a "donor." The stem cells can be obtained from the hollow part of the hip bone or from blood. A serious problem with this treatment is graft-versus-host disease (GVHD). This happens when stem cells from the donor attack normal cells of the recipient. Currently, there is no universal standard of care in the United States to prevent GVHD. This study is being done to see if a medicine that is used to lower cholesterol can also help in reducing GVHD. Patients will receive atorvastatin daily by mouth starting 14 days before stem cell transplant. They will continue to take atorvastatin until 180 days after transplant. This medicine may be stopped earlier if there is a bad side effect or a severe GVHD. Patients will also receive standard treatment to prevent GVHD. Patients will undergo many tests that are standard for their treatment at West Virginia University (WVU), including blood tests to check blood counts, kidney function and HIV status; blood test to check for pregnancy; Multi Gated Acquisition Scan (MUGA scan)or echocardiogram to test heart function; lung function testing; and bone marrow aspirate or biopsy. Patients will also have the option to provide blood samples for optional research related to the study.
Interventions
- DRUG Atorvastatin calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2014-01-20 |
| Est. Completion | 2021-07-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01665677
The ClinicalTrials.gov registry entry for NCT01665677 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mehdi Hamadani, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin calcium is the first listed.
NCT01665677 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01665677 about?
NCT01665677 is a clinical study titled "Atorvastatin as GVHD Prophylaxis for Allogeneic Hematopoietic Cell Transplantation". Hematopoietic stem cell transplantation is a procedure in which a person receives blood forming stem cells from a person called a "donor." The stem cells can be obtained from the hollow part of the hip bone or from blood. A serious problem with this treatment is graft-versus-host disease (GVHD). Th...
What is the current status of trial NCT01665677?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2014-01-20. Estimated completion is 2021-07-09.
What interventions are being tested in trial NCT01665677?
The interventions under investigation include: Atorvastatin calcium (DRUG).
Who is sponsoring clinical trial NCT01665677?
This trial is sponsored by Mehdi Hamadani, which has 2 total clinical trials registered on ClinicalTrials.gov.
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