Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM) - Tabular View

Tracking Information
First Received Date ^ICMJE	November 18, 2003
Last Updated Date	December 6, 2007
Start Date ^ICMJE	June 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00073255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
Official Title ^ICMJE	Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
Brief Summary	To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Condition ^ICMJE	Diabetes Mellitus, Insulin-Dependent
Intervention ^ICMJE	Drug: hokt3g1 (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	Completed
Enrollment ^ICMJE	12
Completion Date	December 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	To be eligible participants will have Type 1 diabetes, diagnosed within the previous 12 months and established by standard American Diabetes Association criteria. All participants will have autoantibodies: either anti-GAD65, anti-ICA512, or if treated with insulin for less than 7 days, anti-insulin. The age range will be between 8 and 30 years; and a minimum weight of 34 kg.
Gender	Both
Ages	8 Years to 30 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00073255
Responsible Party
Study ID Numbers ^ICMJE	ITNO17AI
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP