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RECRUITING
NCT07254000
PHASE2
Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Sponsor: Monash Medical Centre
View on ClinicalTrials.gov
Summary
A phase 2 randomised, three-arm, parallel-group, dose-ranging trial to determine safety, efficacy and optimal dosing of intravenous anakinra in premature neonates, with subcutaneous pharmacokinetic sub-study.
Key Details
Gender
All
Age Range
24 Weeks - 29 Weeks
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-06-27
Completion Date
2026-12
Last Updated
2025-11-28
Healthy Volunteers
No
Interventions
DRUG
Anakinra (Kineret®)
Standard care plus Anakinra for 21 days
Locations (2)
Monash Children's Hospital
Clayton, Victoria, Australia
Starship Children's Hospital
Grafton, Auckland, New Zealand