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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00073255
First Posted: November 20, 2003
Last Update Posted: January 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
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).

Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent Drug: hokt3g1 (ALA-ALA) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 12
Study Start Date: June 2003
Estimated Study Completion Date: December 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073255


Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

ClinicalTrials.gov Identifier: NCT00073255     History of Changes
Other Study ID Numbers: ITNO17AI (completed)
First Submitted: November 18, 2003
First Posted: November 20, 2003
Last Update Posted: January 15, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases