Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2011-02-28
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rilonacept
Rilonacept
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Interventions
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Rilonacept
Rilonacept given subcutaneously, dose per package labeling, once weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Between the ages of 16 to 45 years
* Have at least one diabetes-related autoantibody present
* Have mean C-peptide level \> 0.2 nmol/L on a mixed meal tolerance test
* Be taking insulin
* Complete written informed consent
Exclusion Criteria
* Have an active infection
* Have serologic evidence of HIV, Hepatitis C, Hepatitis C, or tuberculosis
* Have ongoing use of medications known to affect glucose tolerance
* Have a live vaccine 90 days prior to, or during this study
* Taking any other experimental medication within the past 28 days
* Have prior treatment with rilonacept
* Have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies
* Pregnant or lactating females
* Males and females unwilling to use an acceptable method of contraception for the duration of the study
16 Years
45 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Perrin C White
Director of Pediatric Endocrinology
Principal Investigators
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Perrin C White, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Children's Medical Center
Dallas, Texas, United States
Countries
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Other Identifiers
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IL1T-AI-1022
Identifier Type: -
Identifier Source: org_study_id
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