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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: Completed Phase 3 study, sponsored by Dana-Farber Cancer Institute.
NCT00053976 is a Phase 3 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00053976 record still lists
NCT00053976 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00053976 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00053976's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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