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NCT03241719 · ClinicalTrials.gov registry record · Early Phase 1
Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA
A Early Phase 1 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 2
- Enrollment target
NCT03241719: Clinical Trial Early Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT03241719 is a Early Phase 1 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 2 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03241719, a Early Phase 1 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and 3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2. This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA. Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.
Interventions
- DRUG IL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-10-17 |
| Est. Completion | 2021-07-21 |
| Phase | Early Phase 1 |
Why NCT03241719 stopped before completion
NCT03241719 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which IL-2 is the first listed.
NCT03241719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03241719 about?
NCT03241719 is a clinical study titled "Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA". The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2....
What is the current status of trial NCT03241719?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 2 participants. The study started on 2017-10-17. Estimated completion is 2021-07-21.
What interventions are being tested in trial NCT03241719?
The interventions under investigation include: IL-2 (DRUG).
Who is sponsoring clinical trial NCT03241719?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03241719's enrollment target sits among peer trials
2 1973rd of 2000 higher than 16 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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