Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03701568
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2018-09-27
Brief Title:
A RETROspective Study of Patients With TK2d
Sponsor:
Zogenix MDS Inc
Organization:
UCB Pharma
Study Overview
Official Title:
A RETROspective Study of the Combination of Pyrimidine NucleostIdes in Patients With Thymidine Kinase 2 Deficiency TK2
Status:
COMPLETED
Status Verified Date:
2023-08
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:
RETRO
Brief Summary:
This is a medical chart review study to collect information for patients who have been taking pyrimidine nucleosides for treatment of TK2 deficiency Information from the time of onset of symptoms will be collected to describe the pre treatment course of TK2 deficiency
Detailed Description:
Data to be collected from the time of onset of symptoms related to TK2 deficiency includes medical conditions andor adverse events AEs these should include relationship to TK2 disease andor pyrimidine nucleosides as appropriate as well as date of onset and severity when available When available test reports may be obtained as well as available research biological samples eg blood or tissue samples that may be tested for biomarkers of disease andor effects of medications to treat the mitochondrial disease
Study Oversight
Has Oversight DMC:
None
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?:
None