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NCT05121142 · ClinicalTrials.gov registry record · Phase 1
Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05121142: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT05121142 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05121142, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
While hematopoietic stem cell transplant (HSCT) is an effective therapy, graft versus host disease (GVHD) is the most significant complication after HSCT. Both acute GVHD and chronic GVHD are leading causes of non-relapse morbidity and mortality. Patients with solid organ transplants may participate in this study as well because these patients occasionally develop acute GVHD, which is biologically similar to acute GVHD after an HSCT. Acute graft versus host disease usually occurs within the first 100 days of transplant and can involve the skin, gut, or liver. Chronic graft versus host disease usually occurs after the first 100 days of transplant and can involve skin, eyes, mouth, joints, liver, intestines commonly. These two diseases are different, but both happen due to the imbalance of the donor immune system in the host. The purpose of this research is to learn more about ruxolitinib as a treatment for both acute and chronic GVHD. Specifically, the investigators would like to learn more about the pharmacokinetics (PK - the process of absorption, distribution, metabolism, and elimination from the body - meaning how the drug moves through the body) and the pharmacodynamics (PD - the body's biological response to the drug) of ruxolitinib.
Primary Outcome
Maximum Plasma Concentration of ruxolitinib
Interventions
- DRUG Ruxolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-10-27 |
| Est. Completion | 2023-05-13 |
| Phase | Phase 1 |
What the finished NCT05121142 record still lists
NCT05121142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Ruxolitinib is the first listed.
NCT05121142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05121142 about?
NCT05121142 is a clinical study titled "Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease". While hematopoietic stem cell transplant (HSCT) is an effective therapy, graft versus host disease (GVHD) is the most significant complication after HSCT. Both acute GVHD and chronic GVHD are leading causes of non-relapse morbidity and mortality. Patients with solid organ transplants may participate...
What is the current status of trial NCT05121142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-10-27. Estimated completion is 2023-05-13.
What interventions are being tested in trial NCT05121142?
The interventions under investigation include: Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT05121142?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05121142's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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