Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-28 @ 7:44 AM
Study NCT ID:
NCT05955235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
Sponsor:
SCM Lifescience Co., LTD.
Organization:
Study Overview
Official Title:
A Long-term Safety Follow-up Study of SCM-AGH in Patients Who Completed SCM-APT2001 Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
None
Brief Summary:
This is a long-term safety follow-up study of the Phase I/IIa multicenter study of SCM-AGH in subjects with moderate to severe acute pancreatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol SCM-APT2001 (ClinicalTrials.gov ID: NCT04189419) will be eligible for this long-term follow-up protocol.
Detailed Description:
Subjects who meet all eligibility criteria for Long Term Follow-Up(LTFU) study participation at the SCM-APT2001 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: