A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Launched by INFACARE PHARMACEUTICALS CORPORATION, A MALLINCKRODT COMPANY · Feb 24, 2009

Keywords

ClinConnect Summary

The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Babies may only participate if they meet all the following criteria:
• • Is a term or late preterm baby
• • Is at risk for protocol-defined hemolytic disease
• • Weighs at least 2500 g (5.5 lbs)
• • Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age
• • Has parents/guardians who are willing to follow light precautions and sign informed consent
• Exclusion Criteria:
• The following criteria will make a baby not eligible to participate:
• • Needs medications that may prolong the QT interval
• • Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias
• • Has an Apgar score of 6 or below at age 5 minutes
• • Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results