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NCT00228839 · ClinicalTrials.gov registry record · Phase 1
GVH 022P: Study Using Anti Tumor Necrosis Factor Antibody (Infliximab) for Treatment of Acute Graft Versus Host Disease
A Phase 1 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
NCT00228839 is a Phase 1 study that has completed, run by Emory University.
The verdict
NCT00228839, a Phase 1 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
Study Summary
Acute graft versus host disease (GVHD) remains one of the most significant and potentially lethal complications of allogeneic bone marrow transplantation. Depending upon the type of transplant, the incidence of acute GVHD varies between 20 - 50% in related donor transplants, or as high as 70 - 90% in unrelated donor transplants. Acute GVHD affects the skin, liver and gastrointestinal (GI) tract and usually occurs within 20 - 40 days of the bone marrow infusion. Steroids are the standard initial treatment of acute GVHD, with approximately 50% of the patients either free of disease or requiring no further therapy. In the remaining patients, the GVHD either does not respond or it comes back during the tapering of steroids. These patients have a much worse prognosis with a mortality rate greater than 70%. Studies using additional agents such as antithymocyte globulin (ATG), monoclonal antibodies, and anti-lymphocyte globulin showed no improvement over the use of steroids alone. This leads the investigators to look for new immunosuppressive agents that can reduce the risk and severity of acute GVHD. The major purpose of this study is to evaluate the way the body uses and absorbs (the pharmacokinetic profile) a drug called anti tumor necrosis factor antibody (infliximab) for the treatment of acute GVHD. Infliximab is currently indicated for the treatment of immunologic-based diseases (rheumatoid arthritis, moderately to severely active Crohn's disease, and fistulizing Crohn's disease), assuming patients have had inadequate responses to conventional therapy. It is not approved for the treatment of GVHD. This is a Phase I pharmacokinetic study that is coordinated by the Pediatric Blood and Marrow Transplant Consortium (PBMTC). The study will be conducted in the Blood and Marrow Transplantation (BMT) program at Children's Healthcare of Atlanta - Egleston, Emory University Department of Pediatrics. The goal is to enroll 1 - 2 patients on this study; accrual will be via the
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Est. Completion | 2006-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00228839
The ClinicalTrials.gov registry entry for NCT00228839 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT00228839 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00228839 about?
NCT00228839 is a clinical study titled "GVH 022P: Study Using Anti Tumor Necrosis Factor Antibody (Infliximab) for Treatment of Acute Graft Versus Host Disease". Acute graft versus host disease (GVHD) remains one of the most significant and potentially lethal complications of allogeneic bone marrow transplantation. Depending upon the type of transplant, the incidence of acute GVHD varies between 20 - 50% in related donor transplants, or as high as 70 - 90% i...
What is the current status of trial NCT00228839?
This trial is currently completed. It is a Phase 1 study. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00228839?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT00228839?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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