Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Type I Diabetes

In brief

This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of standard therapy for diabetic ketoacidosis in children and its effect on intracranial pressure.

Key facts

Study ID

NCT01477476

Run by

University of Colorado, Denver

People needed

0

Starts

2012-03-01

Expected to finish

2016-04-22

Last updated by the study team

2019-04-18

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 8-18 years at diagnosis of type 1 diabetes
• Diabetic ketoacidosis with:
• plasma glucose concentration >300 mg/dl,
• venous pH <7.30 or
• serum bicarbonate concentration <15 mmol/L, and
• ketones in urine or serum
• Hematology:
• WBC >3000 x 109/L;
• platelets >100,000 x 109/L;
• hemoglobin >10.0 g/dL
• Negative blood pregnancy test in females.

You may not qualify if…

• Children with underlying disorders, including:
• active autoimmune or immune deficiency disorder other than type 1 diabetes,
• malignancy,
• organ transplant,
• any condition requiring chronic corticosteroid use
• Previous immunotherapy to prevent type 1 diabetes
• Current or prior infection with HIV, hepatitis B or hepatitis C assessed by history
• Patients who present with DKA concomitant with alcohol or drug use,
• Head trauma,
• Meningitis or other conditions which might affect neurological function
• Renal failure
• Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject's participation
• Patients with a history of known hypersensitivity to:
• E coli-derived proteins,
• anakinra, or
• any components of the investigational drug product

Where it is running

• Childrens Hospital Colorado — Aurora, Colorado, United States
• University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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