Status:
TERMINATED
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Lead Sponsor:
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Conditions:
Hyperbilirubinemia, Neonatal
Eligibility:
All Genders
1-48 years
Phase:
PHASE2
Brief Summary
It is a normal process in the human body for red blood cells to die, which makes bilirubin. Bilirubin is cleared away through the liver. Some babies are born with livers that don't work well enough ...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00850993
Start Date
August 1 2008
End Date
May 1 2012
Last Update
October 30 2019
Active Locations (23)
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1
Arrowhead Regional Med Center
Colton, California, United States, 92324
2
UCSD Medical Center
San Diego, California, United States, 92103
3
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
4
University of Louisville
Louisville, Kentucky, United States, 40202