Replies to post #5309 on Capricor Therapeutics Inc (CAPR)

[mick]

$CAPR READING

https://clinicaltrials.gov/ct2/show/NCT04428476?term=Capricor&draw=2&rank=5

RE;
Trial record 5 of 9 for: Capricor
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Open-label Extension of the HOPE-2 Trial (HOPE-2-OLE)

Brief Summary:
This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of four intravenous administrations of CAP-1002, each separated by three months. Subjects will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of CAP-1002.

Subjects will complete trial assessments at Screening; Day 1; Months 3, 6, 9 and 12. Safety and efficacy assessments will be conducted prior to CAP-1002 administration at the Day 1, Months 3, 6 and 9 trial visits, unless otherwise indicated.

All CAP-1002 infusions will be conducted in an outpatient setting at the investigative site on Day 1 and Months 3, 6 and 9. Subjects will be observed in the outpatient setting for at least two hours post infusion and then discharged the same day if medically cleared by the site Investigator.


Responsible Party: Capricor Inc.
ClinicalTrials.gov Identifier: NCT04428476 History of Changes
Other Study ID Numbers: CAP-1002-DMD-02-OLE
First Posted: June 11, 2020 Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No