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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: Completed Phase 2 study, sponsored by Northside Hospital.
NCT01161628 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01161628 record still lists
NCT01161628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.
NCT01161628 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01161628's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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