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NCT00048789 · ClinicalTrials.gov registry record · Phase 2
Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00048789 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 25 participants.
The verdict
NCT00048789, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) for treating chronic graft-versus-host disease (GvHD). GvHD is a common complication of stem cell transplantation using donated stem cells. It occurs when the donor's T-lymphocytes (a type of immune cell) see the patient's cells as foreign and mount an immune response to reject them. The attack can cause skin rash, mouth sores, liver or lung inflammation, lack of appetite, and muscle stiffness. Chronic GvHD can cause serious illness, and even death, from the long-term effects of immune dysfunction and from toxic effects of medications (such as cyclosporine and prednisone) used to treat it. ECP is an experimental treatment designed to stop the lymphocytes from attacking the body. It involves collecting some of the cells that cause GvHD, treating them with a combination of drug and light therapy and returning them to the body. Sixty to 80 percent of patients with chronic GvHD improve with ECP treatment, and some patients can stop treatment with prednisone or cyclosporine, or reduce the drug dosages. Patients with chronic GvHD whose condition has not improved after a minimum 14-day course of cyclosporine and prednisone may be eligible for this study. Patients must be able to travel to the NIH Clinical Center in Bethesda, Maryland, twice a week during the 3-month study period. Upon entering the study, participants will have a baseline evaluation to measure the extent of GvHD. This assessment includes blood tests, eye and dental examinations, skin biopsy for patients with skin involvement, and CT scans and lung function tests to look for possible lung involvement. Biopsies of the lung, liver, mouth, or eye may be requested if needed to confirm GvHD in these tissues. The skin will be photographed before starting ECP treatment and once a month during the treatment period. Following baseline tests, participants will undergo treatment and evaluations as follows: ECP Treatment Pati
Interventions
- PROCEDURE Extracorporeal Photopheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2002-11-04 |
| Est. Completion | 2009-01-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048789
The ClinicalTrials.gov registry entry for NCT00048789 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Extracorporeal Photopheresis is the first listed.
NCT00048789 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048789 about?
NCT00048789 is a clinical study titled "Extracorporeal Photopheresis to Treat Chronic Graft-Versus-Host Disease". This study will examine the safety and effectiveness of extracorporeal photopheresis (ECP) for treating chronic graft-versus-host disease (GvHD). GvHD is a common complication of stem cell transplantation using donated stem cells. It occurs when the donor's T-lymphocytes (a type of immune cell) see ...
What is the current status of trial NCT00048789?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2002-11-04. Estimated completion is 2009-01-29.
What interventions are being tested in trial NCT00048789?
The interventions under investigation include: Extracorporeal Photopheresis (PROCEDURE).
Who is sponsoring clinical trial NCT00048789?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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