Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868499
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-12
First Post:
2023-05-08
Brief Title:
Rollover Study From EXG-US-01
Sponsor:
Elixirgen Therapeutics Inc
Organization:
Elixirgen Therapeutics Inc
Study Overview
Official Title:
Long Term Follow-up Study in Patients With Telomere Biology Disorders With Bone Marrow Failure Who Completed Study EXG-US-01
Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
This is a long-term rollover follow-up study for Phase III study Protocol EXG-US-01
Detailed Description:
Patients who received EXG34217 treatment and had at least one follow-up visit Month 1 3 6 or 12 in Study EXG-US-01 will be eligible for this rollover study Patient will sign a consent form prior to any study related procedure This study is to add additional follow-up assessments up to 6 years after EXG34217 treatment This study does not have additional intervention Additional visits will be every 6 months in the first 3 years and once a year for two years
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