Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008801
Status:
UNKNOWN
Last Update Posted:
2005-11-01
First Post:
2001-01-16
Brief Title:
hOKT3gamma1 Ala-Ala for the Prevention of Human Islet Allograft Failure
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
hOKT3gamma1 Ala-Ala for the Prevention of Human Islet Allograft Failure
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The broad long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy More specifically the objectives of these studies is to conduct an open-labeled one-year follow-up Phase III study in patients with surgical and type 1 diabetes to determine the safety tolerability immune activity and pharmacokinetics of hOKT3gamma1 Ala-ala administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants
Detailed Description:
Adverse events will be monitored and recorded throughout the first year post-transplant The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 Ala-ala administration Successful completion of the proposed clinical trial will increase our understanding of the safety efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 Ala-ala for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients
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?: