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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 is a Phase 2 study that has completed, run by Capricor. The registered enrollment target is 25 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02485938
The ClinicalTrials.gov registry entry for NCT02485938 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Capricor, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Allogeneic Cardiosphere-Derived Cells (CAP-1002) is the first listed.
NCT02485938 reports 0 study locations.
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.
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