Anakinra Pilot 2 - A Study to Optimise Dose and Route of Administration of Anakinra in Preterm Infants
Recruiting
Phase 2
Interventional Study
Premature Infants
Very Premature Infants
Inflammation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 24 Weeks – 29 Weeks
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 24 (estimated)
- Sponsor
- Monash Medical Centre · Other
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Born between 24+0 and 28+6 weeks of gestation
Exclusion Criteria:
* Inability of the legal representatives to consent,
* Genetic syndromes,
* Severe cardiac anomalies,
* Substantial pre-/perinatal compromise,
* Congenital diaphragmatic hernia,
* Intrauterine stroke,
* Condit…
Contacts