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NCT00053976 · ClinicalTrials.gov registry record · Phase 3
Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease
A Phase 3 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT00053976 is a Phase 3 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 105 participants.
The verdict
NCT00053976, a Phase 3 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates. Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them, investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication, Zenapax, will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD. Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient with kidney transplant to help prevent graft rejection. This medication has been used in bone marrow transplant patients to treat GVHD.
Interventions
- DRUG Placebo
- DRUG methylprednisolone
- BIOLOGICAL Daclizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2001-01 |
| Est. Completion | 2004-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00053976
The ClinicalTrials.gov registry entry for NCT00053976 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00053976 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00053976 about?
NCT00053976 is a clinical study titled "Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease". The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether additi...
What is the current status of trial NCT00053976?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2001-01. Estimated completion is 2004-11.
What interventions are being tested in trial NCT00053976?
The interventions under investigation include: Placebo (DRUG), methylprednisolone (DRUG), Daclizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00053976?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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