Immunological Data Discovery Index
Immunological Data Discovery Index
| identifier: | ITN017AI |
| description: |
This study evaluated the safety and pharmacokinetics (PK) of hOKt3γ1 (Ala-Ala) in participants with Type 1 diabetes mellitus. A first group of 4 participants received a dosing regimen consisting of 12 intravenous doses on 12 consecutive days. Subsequent participants received a modified (upward or downward) dose of hOKt3γ1 (Ala-Ala) based on the observed safety profile (AE severity and time to recovery of lymphocyte count) from the previous dose group. Safety and PK was completed for each participant 30 days post-enrollment. Participants were followed for 2 years.
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| privacy: |
Not Provided
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| aggregation: |
instance of dataset
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| availability: |
available with registration
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| relatedIdentifiers: |
Herold I
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| acknowledges: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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| isAbout: |
Drug: hokt3g1 (ALA-ALA)
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| authorizations: |
registration required
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| accessURL: |
https://www.clinicaltrials.gov/ct2/show/NCT00073255 |
| landingPage: |
https://www.itntrialshare.org/project/Studies/ITN017AIPUBLIC/Study%20Data/begin.view? |
| study type: | Interventional |
| study phase: | Phase 1 |
| subject gender: | Sexes Eligible for Study: All |
| subject age: | 8 Years to 30 Years (Child, Adult) |
| study category: | |
| study type: | Interventional |
| name: |
Diabetes Mellitus, Insulin-Dependent
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| name: |
Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKt3γ1 (Ala-Ala) in Participants with Type 1 Diabetes Mellitus
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| size: |
12
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| output: |
Not Provided
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| identifier: |
NCT00073255
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| selectionCriteria: |
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.
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| name: |
Evaluation of Tolerability, Safety, and Pharmacokinetics of hOKT3g1 (Ala-Ala)
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| studyGroups: |
Not Provided
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| description: |
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).
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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| location: |
United States
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| startDate: |
2003-06-01
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| name: |
ITN TrialShare
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| homePage: |
https://www.itntrialshare.org |
