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NCT02485938 · ClinicalTrials.gov registry record · Phase 2
HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne)
A Phase 2 study, sponsored by Capricor.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT02485938: Completed Phase 2 study, sponsored by Capricor.
NCT02485938 is a Phase 2 study that has completed, run by Capricor. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02485938, a Phase 2 study, has completed, sponsored by Capricor.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
Male participants with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all inclusion and no exclusion criteria will be randomized. All participants will be at least 12 years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the active treatment arm, all three major cardiac territories will be treated (infused) during a single procedure in an open-label fashion.
Primary Outcome
Adjudicated Events reported included: New thrombolysis in myocardial infarction (TIMI) flow 0-2 or TIMI myocardial perfusion grade (TMPG) 0-2noted immediately following infusion and persisting greater than (\>) 3 minutes, despite intracoronary vasodilator administration; sudden unexpected death within 72 hours of intracoronary infusion; and Major adverse cardiac event (MACE) within 72 hours of intracoronary infusion, including death, non-fatal myocardial infarction and hospitalization for cardio
Interventions
- DRUG Allogeneic Cardiosphere-Derived Cells (CAP-1002)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2016-01-07 |
| Est. Completion | 2017-09-14 |
| Phase | Phase 2 |
What the finished NCT02485938 record still lists
NCT02485938 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Allogeneic Cardiosphere-Derived Cells (CAP-1002) is the first listed.
NCT02485938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02485938 about?
NCT02485938 is a clinical study titled "HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne)". Male participants with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all inclusion and no exclusion criteria will be randomized. All participants will be at least 12 years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of CAP-1002 in three co...
What is the current status of trial NCT02485938?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2016-01-07. Estimated completion is 2017-09-14.
What interventions are being tested in trial NCT02485938?
The interventions under investigation include: Allogeneic Cardiosphere-Derived Cells (CAP-1002) (DRUG).
Who is sponsoring clinical trial NCT02485938?
This trial is sponsored by Capricor, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02485938's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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