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



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

For Condition: Diabetes Mellitus, Insulin-Dependent
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: 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).
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 8 Years/30 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 12

Location and Contact Information:

Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Kevan  Herold 212-851-5492


Additional Information:
Study ID Numbers:
  ITNO17AI; 
Study Start Date: June 2003
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073255

Other Diabetes Mellitus, Insulin-Dependent Studies:
1. Continuous Glucose Monitoring in Children With Type 1 Diabetes Mellitus

2. Safety and Efficacy of INGAP-Peptide in Patients with Type 1 Diabetes

3. hOKT3gamma1 (Ala-ala) for the prevention of human islet allograft failure

4. Continuous Glucose Monitors for Children With Diabetes Mellitus

5. The GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children

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

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