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NCT03406884 · ClinicalTrials.gov registry record · Phase 1
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
A Phase 1 study, sponsored by Joshua M Hare.
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT03406884: Completed Phase 1 study, sponsored by Joshua M Hare.
NCT03406884 is a Phase 1 study that has completed, run by Joshua M Hare. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03406884, a Phase 1 study, has completed, sponsored by Joshua M Hare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality.
Primary Outcome
Safety will be reported as the number of incidence of treatment related major adverse cardiac events (MACE). MACE is defined as any of the following: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention, cardiogenic shock, unplanned cardiovascular operation due to injection site bleeding, need for new permanent pacemaker, stroke or embolic event to the brain determined by CT scan and death. MACE will be evaluated by the treating physician and assessed u
Interventions
- BIOLOGICAL c-kit+ cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-16 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 1 |
What the finished NCT03406884 record still lists
NCT03406884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which c-kit+ cells is the first listed.
NCT03406884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03406884 about?
NCT03406884 is a clinical study titled "The CHILD Trial: Hypoplastic Left Heart Syndrome Study.". The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II Bidirectional Cavopulmonary Anastomosis (BDCPA) operation and to observe effects on clinical outcome including right ventricular myocardial functi...
What is the current status of trial NCT03406884?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2019-10-16. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT03406884?
The interventions under investigation include: c-kit+ cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT03406884?
This trial is sponsored by Joshua M Hare, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03406884's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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