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NCT02188719 · ClinicalTrials.gov registry record · Phase 1
Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02188719: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02188719 is a Phase 1 study that was terminated before completion, 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
NCT02188719, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is look at the safety of: * Taking a specific combination of immunosuppressant drugs after liver transplantation * Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells (darTregs) while taking this specific combination of drugs
Primary Outcome
Biopsy-proven acute rejection graded as Mild, Moderate or Severe, per 1997 Banff classification. Chronic Rejection graded using Banff 2000 classification. References: 1.) Banff Schema for Grading Liver Allograft Rejection: An International Consensus Document developed by an international panel of experts in liver transplantation pathology, hepatology, and surgery (Hepatology 1997; 25(3): 658-663). 2.) Update of the International Banff Schema for Liver Allograft Rejection: Working Recommendation
Interventions
- DRUG Everolimus
- DRUG Tacrolimus
- DRUG Mycophenolate mofetil
- BIOLOGICAL Anti-Thymocyte Globulin - Rabbit
- BIOLOGICAL darTreg Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2019-06-18 |
| Phase | Phase 1 |
Why NCT02188719 stopped before completion
NCT02188719 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 Everolimus is the first listed.
NCT02188719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02188719 about?
NCT02188719 is a clinical study titled "Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation". The purpose of this study is look at the safety of: * Taking a specific combination of immunosuppressant drugs after liver transplantation * Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells (darTregs) while taking this specific combination of drugs
What is the current status of trial NCT02188719?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-12-17. Estimated completion is 2019-06-18.
What interventions are being tested in trial NCT02188719?
The interventions under investigation include: Everolimus (DRUG), Tacrolimus (DRUG), Mycophenolate mofetil (DRUG), Anti-Thymocyte Globulin - Rabbit (BIOLOGICAL), darTreg Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02188719?
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 NCT02188719'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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