Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304064
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-03-05
Brief Title:
Halt cardiomyOPathy progrEssion in Duchenne HOPE-OLE
Sponsor:
Capricor Inc
Organization:
Capricor Inc
Study Overview
Official Title:
Open-Label Extension of the Halt Cardiomyopathy Progression in Duchenne HOPE-Duchenne Trial CAP-1002-DMD-03
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOPE-OLE
Brief Summary:
This Phase 2 multi-center open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study NCT02485938 and completed 12 months of follow-up
The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002 each separated by three months
The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002 each separated by three months
Detailed Description:
Participants with documented enrollment in the Usual Care treatment group of the HOPE-Duchenne study and completion of study follow-up through Month 12 were eligible for this study
Participants 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
All CAP-1002 infusions will be conducted in an outpatient setting at the investigative site on Day 1 and at Month 3 Participants 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
Participants 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
All CAP-1002 infusions will be conducted in an outpatient setting at the investigative site on Day 1 and at Month 3 Participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None