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Anakinra and Kawasaki Disease

NCT02390596 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-02

No results posted yet for this study

Summary

The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.

Conditions

  • Kawasaki Disease
  • Children

Interventions

DRUG

Anakinra

The dose of Anakinra will be 2mg/kg (patients \<10kg and/or \<8 months: 4mg/kg). If the patient remains febrile (fever \>38°C), he will receive a double dose of anakinra 4mg/kg (patients \<10kg and/or \<8 months: 6mg/kg) at day1 instead of 2mg/kg. If the patient does not respond to the 4mg/kg dose at visit 3; d1 within 24 hours, he will receive at visit 4; d2, 6mg/kg of anakinra (patients \<10kg and/or \<8 months: 8mg/kg). Treatment will be continued until they have achieved complete response as defined in the outcome measurement section, and during a maximum of 15 days.

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Isabelle Koné-Paut, MD, PhD · AP-HP, Bicêtre Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2019-01-21
Completion
2019-02-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02390596 on ClinicalTrials.gov