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NCT02474199 · ClinicalTrials.gov registry record · Phase 1
Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02474199: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02474199 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02474199, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This research study is for liver transplant recipients and their respective living donors. The purpose of this study is: 1. To see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells (Tregs) 2. To see if the Tregs allows a liver recipient to take less, or completely stop medications normally taken after receiving an organ transplant.
Primary Outcome
The National Cancer Institute - Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 was used to grade the severity of all AEs. A participant was considered to have met this endpoint if they experienced at least one CTCAE Grade 3 or higher AE deemed attributable (i.e., considered at least possibly related) to darTreg infusion (infusion reaction, cytokine release syndrome).
Interventions
- DRUG Acetaminophen
- DRUG Diphenhydramine
- BIOLOGICAL darTregs
- DRUG Immunosuppression (IS) Withdrawal
- PROCEDURE Study Mandated Procedures
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-06-06 |
| Est. Completion | 2019-12-16 |
| Phase | Phase 1 |
What the finished NCT02474199 record still lists
NCT02474199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT02474199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02474199 about?
NCT02474199 is a clinical study titled "Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction". This research study is for liver transplant recipients and their respective living donors. The purpose of this study is: 1. To see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells (Tregs) 2. To see if the Tregs allows a liver recipient to take less, or co...
What is the current status of trial NCT02474199?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2016-06-06. Estimated completion is 2019-12-16.
What interventions are being tested in trial NCT02474199?
The interventions under investigation include: Acetaminophen (DRUG), Diphenhydramine (DRUG), darTregs (BIOLOGICAL), Immunosuppression (IS) Withdrawal (DRUG), Study Mandated Procedures (PROCEDURE).
Who is sponsoring clinical trial NCT02474199?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02474199's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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