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NCT01161628 · ClinicalTrials.gov registry record · Phase 2
Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)
A Phase 2 study, sponsored by Northside Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT01161628 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 25 participants.
The verdict
NCT01161628, a Phase 2 study, has completed, sponsored by Northside Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. The investigators hope to demonstrate that Rituximab has significant activity in cGVHD when utilized early in the course of the process. In addition, the investigators hope to show that the early use of Rituximab may allow for the earlier discontinuation of immunosuppression while obviating the need for long courses of systemic corticosteroids, which should translate into reduced treatment-related morbidity and mortality associated with cGVHD.
Interventions
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01161628
The ClinicalTrials.gov registry entry for NCT01161628 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 Northside Hospital, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.
NCT01161628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01161628 about?
NCT01161628 is a clinical study titled "Rituximab for the Primary Treatment of Denovo Extensive Chronic Graft Versus Host Disease (GVHD)". Rituximab is an attractive agent to bring to the upfront treatment of chronic graft-versus-host disease (cGVHD) due to its favorable toxicity profile, its proven efficacy in the treatment of steroid-refractory cGVHD, and its ability to serve as a steroid sparing agent in other autoimmune diseases. T...
What is the current status of trial NCT01161628?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-04. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01161628?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT01161628?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
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