Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05506254
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-12
First Post:
2022-08-16
Brief Title:
Long-term Follow-up Study of Patients Who Received hLB-001 Gene Therapy
Sponsor:
LogicBio Therapeutics Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
A Long-term Follow-up Study of Patients in LogicBio Clinical Trials for Methylmalonic Acidemia Characterized by MMUT Mutations Who Received hLB-001
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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 non-interventional long-term follow-up study of patients who have participated in LogicBio studies for the treatment of MMA and received hLB-001
Detailed Description:
Patients will be followed for a period of 15 years which includes the duration of time that the patient was in the treatment study
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