NCT00719407

Brief Summary

The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

July 17, 2008

Last Update Submit

November 7, 2012

Conditions

Hypoxic-ischemic Encephalopathy

Keywords

birth asphyxianeonatal encephalopathyhypoxic-ischemic encephalopathyneuroprotectionneonate

Outcome Measures

Primary Outcomes (1)

  • Serious adverse event

    14 days of life

Secondary Outcomes (1)

  • Pharmacokinetic parameters

    1 to 11 days of life

Study Arms (1)

A

EXPERIMENTAL

All enrolled patients will be in this single arm, who will receive experimental drug treatment.

Drug: erythropoietin

Interventions

erythropoietinDRUG

250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)

Also known as: Procrit
A

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ≥ 36 weeks gestational age
  • Perinatal depression (low Apgar score, need for resuscitation)
  • Moderate to severe encephalopathy

You may not qualify if:

  • Specific aEEG findings
  • Intrauterine growth restriction
  • Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
  • Microcephaly
  • Infant older than 23.5 hours of age at the time of consent
  • Infant judged by an attending physician to be likely to die due to the severity of illness
  • Polycythemia
  • Hypertension
  • No in-dwelling line

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (3)

  • Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27.

    PMID: 25439577DERIVED

  • Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.

    PMID: 24524452DERIVED

  • Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24.

    PMID: 23008465DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainAsphyxia Neonatorum

Interventions

ErythropoietinEpoetin Alfa

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Yvonne W Wu, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology and Pediatrics

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

November 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

US(1)