A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Hyperbilirubinemia, Neonatal
In brief
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 yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice). This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high. Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin. This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.
Key facts
- Study ID
- NCT00850993
- Run by
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- People needed
- 58
- Starts
- 2008-08-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2019-10-30
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Arrowhead Regional Med Center — Colton, California, United States
- UCSD Medical Center — San Diego, California, United States
- Kapi'olani Medical Center for Women and Children — Honolulu, Hawaii, United States
- University of Louisville — Louisville, Kentucky, United States
- Westchester Medical Center — Valhalla, New York, United States
- ECU Brody School of Medicine — Greenville, North Carolina, United States
- St. Vincent Mercy Children's Hospital — Toledo, Ohio, United States
- Drexel University College of Medicine, Clinical Research Group — Philadelphia, Pennsylvania, United States
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
- Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care — Bydgoszcz, Poland
- Research Institute of Polish Mother's Health Center — Lodz, Poland
- Neonatal Department Warsaw Medical University — Warsaw, Poland
- Complejo Hospitalario Universitario A Coruña — A Coruña, Spain
- Hospital Vall D´Hebrón — Barcelona, Spain
- Hospital Clinic i Provincial — Barcelona, Spain
- Hospital Doce de Octubre — Madrid, Spain
- Hospital La Paz — Madrid, Spain
- University Hospital Santiago de Compostela-L Coruna — Santiago de Compostela, Spain
- Municipal Medical Institution "Regional pediatric clinical hospital #1", Department of pathology of the newborns; Bukovynian State Medical University, Department of Pediatrics and Children's Infectious Diseases — Chernivtsi, Ukraine
- National Pediatric Specialized Hospital "OHMATDYT". — Kiev, Ukraine
- State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department — Kiev, Ukraine
- Municipal Institution "Odessa regional clinical hospital", Department of pathology of the newborns and premature infants; Odessa State Medical University; Chair of Pediatrics #1 and Neonatology — Odesa, Ukraine
- Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1 — Vinnitsa, Ukraine
Full record on ClinicalTrials.gov
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