Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-04 @ 8:14 PM
Study NCT ID:
NCT06590493
Status:
AVAILABLE
Last Update Posted:
2025-09-12
First Post:
2024-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxecitine and Doxribtimine-Expanded Access
Sponsor:
UCB BIOSCIENCES, Inc.
Organization:
Study Overview
Official Title:
Doxecitine and Doxribtimine-Expanded Access
Status:
AVAILABLE
Status Verified Date:
2025-09
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 Expanded Access Record for doxecitine and doxribtimine includes the following managed access programs and status:
TK0113: Available TK0115: Available
TK0113: Available TK0115: Available
Detailed Description:
TK0113: Data Collection for Patients in the Company Supported Expanded Access Program TK0115: TREATMENT PROTOCOL FOR DOXECITINE AND DOXRIBTIMINE - Company-sponsored Intermediate-size Cohort Expanded Access Program for Doxecitine and Doxribtimine for Patients with Thymidine Kinase 2 Deficiency (TK2d) with an Age of Symptom Onset ≤ 12 Years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: