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

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Completed
CT.gov ID
NCT00073255
Collaborator
(none)
12
Enrollment
1
Location
30
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: hokt3g1 (ALA-ALA)
 Phase 1

Study Design

Study Type:
Interventional
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)
Study Start Date :
Jun 1, 2003
Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Locations

    Site City State Country Postal Code
    1 Columbia University New York New York United States 10032

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00073255
    Other Study ID Numbers:
    • ITNO17AI (completed)
    First Posted:
    Nov 20, 2003
    Last Update Posted:
    Jan 15, 2010
    Last Verified:
    Jan 1, 2010
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Jan 15, 2010