Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06481904
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-26
Brief Title:
Registry for Stage 2 Type 1 Diabetes
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Observational Long-term Safety Study of TZIELD Teplizumab-mzwv in Patients With Stage 2 Type 1 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Stage 2 Type 1 Diabates T1D is an early stage of T1D characterized by dysglycemia but not yet leading to clinical symptoms Progression of the disease to Stage 3 clinical T1D leads to overt hyperglycemia requiring eventually exogenous insulin
TZIELD teplizumab-mzwv has been approved to delay onset of stage 3 T1D by the United States US Food and Drug Administration FDA for adults and children aged 8 years and older with Stage 2 T1D
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD in patients with Stage 2 T1D treated as per standard of care
TZIELD teplizumab-mzwv has been approved to delay onset of stage 3 T1D by the United States US Food and Drug Administration FDA for adults and children aged 8 years and older with Stage 2 T1D
The purpose of this study is to collect general information on patients with stage 2 T1D and further information on the long-term effects of TZIELD in patients with Stage 2 T1D treated as per standard of care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| U1111-1306-6690 | REGISTRY | None | None |