Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04655911
Status:
TERMINATED
Last Update Posted:
2022-05-31
First Post:
2020-11-17
Brief Title:
A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101
Sponsor:
Abeona Therapeutics Inc
Organization:
Abeona Therapeutics Inc
Study Overview
Official Title:
A Long-term Follow-up Study of Patients With MPS IIIB From Gene Therapy Clinical Trials Involving the Administration of ABO-101 rAAV9CMVhNAGLU
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Abeona has decided to discontinue development activities for Product AB0-101 due to a lack of drug supply and for business reasons unrelated to the product safety profile andor signs of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter non-interventional long-term follow-up LTFU study in participants who have been treated with ABO-101 in a prior trial Eligible participants will undergo clinical evaluations at prespecified intervals for 3 years from the last visit in the prior clinical trial up to 5 years post-treatment
Detailed Description:
This is a multicenter noninterventional long-term follow-up study of patients with Mucopolysaccharidosis IIIB MPS IIIB who have completed a prior clinical trial involving the administration of ABO-101 This study is designed to provide LTFU in accordance with the FDA and European Medicines Agency EMA guidelines for patients treated with gene therapy products The duration of the current study is 3 years for a total of up to 5 years post-treatment for these participants who rollover from a prior clinical trial of ABO-101 Participants will have a maximum of 5 annual scheduled visits with assessments as specified in the schedule of assessments
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002936-97 | EUDRACT_NUMBER | None | None |