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NCT03616184 · ClinicalTrials.gov registry record · Phase 2
Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids
A Phase 2 study of Graft-versus-host Disease (GVHD), sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
- 5
- Study locations
NCT03616184: Completed Phase 2 study of Graft-versus-host Disease (GVHD), sponsored by University of Nebraska.
NCT03616184 is a Phase 2 study of Graft-versus-host Disease (GVHD) that has completed, run by University of Nebraska. The registered enrollment target is 49 participants, below the 379-participant average among 3 other Graft-versus-host Disease (GVHD) trials with a reported enrollment target (87% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03616184, a Phase 2 study of Graft-versus-host Disease (GVHD), has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
- 5
- Study locations
Study Summary
The primary objective of the study is to examine the efficacy of ruxolitinib in patients with sclerotic chronic graft-versus-host disease (GVHD).
Primary Outcome
The primary endpoint of the study was complete or partial response in skin and/or joint defined according to the 2014 NIH cGVHD Consensus Criteria. Partial response for skin would be a decrease in NIH Skin Score by 1 or more points. Partial response in joint would be a decrease in NIH Joint and Fascia Score by 1 or more points or increase in P-ROM score by 1 point for any site.
Conditions Studied
Interventions
- DRUG Ruxolitinib
Study Locations (5)
Ohio
- Cleveland Clinic - Cleveland
- Ohio State University - Columbus
Florida
- Moffitt Cancer Center - Tampa
Nebraska
- University of Nebraska Medical Center - Omaha
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2023-06-12 |
| Phase | Phase 2 |
What the finished NCT03616184 record still lists
NCT03616184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 379-participant average among 3 other Graft-versus-host Disease (GVHD) trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Graft-versus-host Disease (GVHD) appearing as the primary indexed condition, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT03616184 lists 5 locations in 4 states (Ohio, Florida, Nebraska).
Frequently Asked Questions
What is clinical trial NCT03616184 about?
NCT03616184 is a clinical study titled "Study of Ruxolitinib in Sclerotic Chronic Graft-Versus-Host Disease After Failure of Systemic Glucocorticoids". The primary objective of the study is to examine the efficacy of ruxolitinib in patients with sclerotic chronic graft-versus-host disease (GVHD).
What is the current status of trial NCT03616184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2018-09-05. Estimated completion is 2023-06-12.
What conditions does trial NCT03616184 study?
This clinical trial studies the following conditions: Graft-versus-host Disease (GVHD).
What interventions are being tested in trial NCT03616184?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT03616184?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03616184 being conducted?
This trial has 5 study locations across Florida, Nebraska, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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