NCT00719407

Neonatal Erythropoietin in Asphyxiated Term Newborns

Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.

Conditions

• Hypoxic-ischemic Encephalopathy

Interventions

Type	Name	Description
DRUG	erythropoietin	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)

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-09-01
• Completion: 2012-11-01
• First posted: 2008-07-21
• Last updated: 2012-11-09

Locations

1 site across 1 country: United States