drugset

drugset / Trial / NCT05280340

Anakinra for Preterm Infants Pilot

NCT05280340 ↗

Phase 1/2 Active not recruiting 25 enrolled Monash Medical Centre Hudson Institute of Medical Research · collab Monash University · collab Te Whatu Ora - Health New Zealand · collab University of Auckland, New Zealand · collab

NaSingle-groupOpen-labelTreatment

Summary

Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.

Timeline

Start: 2022-02-15
Primary completion: 2024-03-21
Completion: 2025-03

Publications

Green EA, Metz D, Galinsky R, Atkinson R, Skuza EM, Clark M, Gunn AJ, Kirkpatrick CM, Hunt RW, Berger PJ, Nold-Petry CA, Nold MF. Anakinra Pilot - a clinical trial to demonstrate safety, feasibility and pharmacokinetics of interleukin 1 receptor antagonist in preterm infants. Front Immunol. 2022 Oct 27;13:1022104. doi: 10.3389/fimmu.2022.1022104. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anakinra	Protein / enzyme biologic	0.8 mg/kg	Intravenous
Subject	Anakinra	Protein / enzyme biologic	1 mg/kg	Intravenous
Subject	Anakinra	Protein / enzyme biologic	1.5 mg/kg	Intravenous

Indications

No indication recorded.