Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04428476
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-26
First Post:
2020-06-09
Brief Title:
Open-label Extension of the HOPE-2 Trial
Sponsor:
Capricor Inc
Organization:
Capricor Inc
Study Overview
Official Title:
Open-Label Extension of the HOPE-2 Duchenne Muscular Dystrophy Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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-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 sixteen 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 12 15 18 21 24 27 30 33 36 39 42 45 and 48 Safety and efficacy assessments will be conducted prior to CAP-1002 administration at the Day 1 Months 3 6 9 12 15 18 21 24 27 30 33 36 39 42 and 45 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 9 12 15 18 21 24 27 30 33 36 39 42 and 45 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
Subjects will complete trial assessments at Screening Day 1 Months 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 and 48 Safety and efficacy assessments will be conducted prior to CAP-1002 administration at the Day 1 Months 3 6 9 12 15 18 21 24 27 30 33 36 39 42 and 45 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 9 12 15 18 21 24 27 30 33 36 39 42 and 45 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
Detailed Description:
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 sixteen intravenous administrations of CAP-1002 each separated by three months Subjects will undergo a targeted screening during a 30-day screening period to determine eligibility based on protocol inclusion and exclusion criteria
Eligible subjects will undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of CAP-1002 Administration of CAP-1002 Day 1 should occur within a maximum of 30 days following confirmation of eligibility
Subjects will complete trial assessments at Screening Day 1 Months 3 6 9 12 14 days each 15 18 21 24 27 30 30 33 36 39 42 45 and 48 21 days each Safety and efficacy assessments will be conducted prior to CAP-1002 administration at the Day 1 Months 3 6 9 12 15 18 21 24 27 30 33 36 39 42 and 45 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 9 12 15 18 21 24 27 30 33 36 39 42 and 45 Prior to each CAP-1002 administration medications will be administered to the subject as determined by the Investigator based on the pre-treatment guidelines as outlined in the protocol andor institutional protocols to minimize the risk of potential severe allergic reactions such as anaphylaxis 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 If clinically indicated an unscheduled in-person visit will be performed at the investigative site with targeted assessments based on presentation of signs and symptoms following any infusion
Eligible subjects will undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of CAP-1002 Administration of CAP-1002 Day 1 should occur within a maximum of 30 days following confirmation of eligibility
Subjects will complete trial assessments at Screening Day 1 Months 3 6 9 12 14 days each 15 18 21 24 27 30 30 33 36 39 42 45 and 48 21 days each Safety and efficacy assessments will be conducted prior to CAP-1002 administration at the Day 1 Months 3 6 9 12 15 18 21 24 27 30 33 36 39 42 and 45 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 9 12 15 18 21 24 27 30 33 36 39 42 and 45 Prior to each CAP-1002 administration medications will be administered to the subject as determined by the Investigator based on the pre-treatment guidelines as outlined in the protocol andor institutional protocols to minimize the risk of potential severe allergic reactions such as anaphylaxis 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 If clinically indicated an unscheduled in-person visit will be performed at the investigative site with targeted assessments based on presentation of signs and symptoms following any infusion
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