Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age24-29
SponsorMonash Medical Centre
About this trial
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.
Eligibility criteria
Qualifiers
Born between 24+0 and 28+6 weeks of gestation
Disqualifiers
Inability of the legal representatives to consent,
Genetic syndromes,
Severe cardiac anomalies,
Substantial pre-/perinatal compromise,
Trial design
Treatments tested in this trial
- Anakinra (Kineret®)
Treatment groups
24 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Monash Medical Centre
Lead sponsor
Monash University
Collaborator
Hudson Institute of Medical Research
Collaborator
Liggins Institute
Collaborator
Starship Children's Hospital of New Zealand
Collaborator
Source ClinicalTrials.gov