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NCT02179853 · ClinicalTrials.gov registry record · Phase 1

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

A Phase 1 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 1
Development phase
22
Enrollment target

NCT02179853: Completed Phase 1 study, sponsored by University of California, San Diego.

NCT02179853 is a Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02179853, a Phase 1 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children \< 2 years old with coronary artery abnormalities from KD.

Primary Outcome

The primary outcome measure was the safety and tolerability of anakinra

Interventions

  • DRUG Anakinra

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2014-11
Est. Completion 2022-12
Phase Phase 1
University of California, San Diego

775 total trials

What the finished NCT02179853 record still lists

NCT02179853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 1 intervention - of which Anakinra is the first listed.

NCT02179853 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02179853 about?

NCT02179853 is a clinical study titled "Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease". Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart a...

What is the current status of trial NCT02179853?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2014-11. Estimated completion is 2022-12.

What interventions are being tested in trial NCT02179853?

The interventions under investigation include: Anakinra (DRUG).

Who is sponsoring clinical trial NCT02179853?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02179853's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02179853, the US trial registry maintained by the National Library of Medicine. NCT02179853 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.