hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure - Tabular View

Tracking Information
First Received Date ^ICMJE	January 16, 2001
Last Updated Date	October 31, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00008801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
Official Title ^ICMJE	hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
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 I/II 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 Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Diabetes Mellitus, Insulin-Dependent Diabetes Mellitus, Experimental Transplantation, Homologous Islets of Langerhans Transplantation
Intervention ^ICMJE	Drug: hOKT3gamma1 (Ala-ala)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion: Primary islet allotransplant surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team Age 18 or older must give written informed consent
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00008801
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR00400-0672
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE	Juvenile Diabetes Research Foundation
Investigators ^ICMJE
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	December 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP