Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00378508
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2006-09-18
Brief Title:
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Phase II Trial of hOKT3gamma1Ala-Ala Teplizumab for Treatment of Patients With Recent Onset Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2021-08
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:
None
Brief Summary:
This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody hOKT3gamma1Ala-AlaTeplizumab will prevent the loss of insulin secretory capacity in individuals with Type 1 diabetes of 4 - 12 months duration since diagnosis
Detailed Description:
The study design is a double blind placebo controlled trial that will enroll subjects between the ages of 8 - 30 who have had the diagnosis of Type 1 diabetes made 4 - 12 months prior to enrollment A single 14 course of treatment with mAb hOKT3gamma1Ala-Ala Teplizumab will be given The primary endpoint is the C-peptide response to a mixed meal at 12 months A total of 60 subjects will be enrolled 30 in the drug treatment and 30 in the placebo groups at 4 study sites Yale Universitythe University of California at San Francisco Childrens Hospital of Philadelphia and the Barbara Davis Diabetes Center
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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 |
|---|---|---|---|
| R01DK057846 | NIH | None | httpsreporternihgovquickSearchR01DK057846 |