NCT03079167 (PAEAN) is a Phase 3 clinical trial of Epoetin Alfa in Hypoxic-Ischemic Encephalopathy, sponsored by University of Sydney.

Who is sponsoring NCT03079167?

NCT03079167 is sponsored by University of Sydney.

What drugs are being tested in NCT03079167?

Interventions in NCT03079167: Epoetin Alfa, Normal saline.

What condition does NCT03079167 study?

NCT03079167 studies Hypoxic-Ischemic Encephalopathy.

Is NCT03079167 still recruiting?

NCT03079167 is currently completed. Last updated 5 June 2024.

Last reviewed 2024-06-05 · How we verify

NCT03079167: PAEAN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PAEAN - Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns

Completed Phase 3 Last updated 5 June 2024

What this trial tests

Phase 3 trial testing Epoetin Alfa in Hypoxic-Ischemic Encephalopathy in 313 participants. Completed in 30 April 2024.

Timeline

14 May 2016

Primary endpoint
30 November 2023

30 April 2024

Quick facts

Lead sponsor	University of Sydney
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	313
Start date	14 May 2016
Primary completion	30 November 2023
Estimated completion	30 April 2024
Sites	24 locations across New Zealand, Singapore, Australia

Drugs / interventions tested

Epoetin Alfa (EPOETIN ALFA) — full drug profile →
Normal saline

Conditions studied

Hypoxic-Ischemic Encephalopathy — all drugs for Hypoxic-Ischemic Encephalopathy →

Sponsor

University of Sydney

Who can join

Under 23 Hours, any sex, with Hypoxic-Ischemic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Double-blind, placebo controlled Phase III trial of erythropoietin for hypoxic ischaemic encephalopathy in infants receiving hypothermia. The study aim is to determine whether Epo in conjunction with hypothermia in infants with moderate/severe hypoxic ischaemic encephalopathy (HIE) will improve neurodevelopmental outcomes at 2 years of age, without significant adverse effects, when compared to hypothermia alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns.
Wu YW, Comstock BA, Gonzalez FF, Mayock DE, et al · · 2022 · cited 160× · PMID 35830641 · DOI 10.1056/nejmoa2119660
Treatment of Neonatal Hypoxic-Ischemic Encephalopathy with Erythropoietin Alone, and Erythropoietin Combined with Hypothermia: History, Current Status, and Future Research.
Oorschot DE, Sizemore RJ, Amer AR. · · 2020 · cited 56× · PMID 32098276 · DOI 10.3390/ijms21041487
Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653
Ferroptosis: A Promising Therapeutic Target for Neonatal Hypoxic-Ischemic Brain Injury.
Peeples ES, Genaro-Mattos TC. · · 2022 · cited 41× · PMID 35806425 · DOI 10.3390/ijms23137420
An Assessment of Melatonin's Therapeutic Value in the Hypoxic-Ischemic Encephalopathy of the Newborn.
Cardinali DP. · · 2019 · cited 35× · PMID 31920617 · DOI 10.3389/fnsyn.2019.00034
Free Radicals and Neonatal Brain Injury: From Underlying Pathophysiology to Antioxidant Treatment Perspectives.
Martini S, Castellini L, Parladori R, Paoletti V, et al · · 2021 · cited 21× · PMID 34943115 · DOI 10.3390/antiox10122012
Neonatal asphyxia as an inflammatory disease: Reactive oxygen species and cytokines.
Okazaki K, Nakamura S, Koyano K, Konishi Y, et al · · 2023 · cited 16× · PMID 36776908 · DOI 10.3389/fped.2023.1070743
Neonatal encephalopathy due to suspected hypoxic ischemic encephalopathy: pathophysiology, current, and emerging treatments.
Babbo CC, Mellet J, van Rensburg J, Pillay S, et al · · 2024 · cited 13× · PMID 39237728 · DOI 10.1007/s12519-024-00836-9

Verify or expand the search:

Other trials of Epoetin Alfa

Trials testing the same drug.

NCT07463820 — A Trial Comparing Three Different Treatment Options for Adults With Low-Risk Myelodysplasia and Anemia (A MyeloMATCH Tre · Phase 2 · not yet recruiting
NCT07422480 — A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myel · Phase 3 · recruiting
NCT06581055 — A Retrospective Study to Describe Real-World Treatment Patterns and Clinical Outcomes Among Patients With Myelodysplasti · withdrawn
NCT05564390 — MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Wi · Phase 2 · recruiting
NCT05949684 — ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (M · Phase 3 · recruiting

Other recruiting trials for Hypoxic-Ischemic Encephalopathy

Currently open trials in the same condition.

NCT07020091 — Predicting Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest · active not recruiting
NCT05610085 — A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures · Phase 2 · recruiting
NCT03657394 — Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries · NA · active not recruiting
NCT03682042 — Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up · NA · recruiting
NCT05568264 — Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit · NA · recruiting

Other University of Sydney trials

Trials by the same sponsor.

NCT07173335 — Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas. · NA · not yet recruiting
NCT06908486 — Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain · NA · recruiting
NCT06159660 — Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Function · not yet recruiting
NCT05568381 — Sleep Disturbance in MCI: A Study of a Cognitive Behavioural Therapy Digital Intervention · NA · completed
NCT05184790 — LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03079167 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Sydney
Last refreshed: 5 June 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03079167.

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