A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
- Conditions
- Hyperbilirubinemia, Neonatal
- Interventions
- Registration Number
- NCT00850993
- Lead Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- 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 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 58
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: Stannsoporfin 3.0 mg/kg Stannsoporfin Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed. Cohort 1: Stannsoporfin 1.5 mg/kg Stannsoporfin Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed. Cohort 3: Stannsoporfin 4.5 mg/kg Stannsoporfin Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed. Cohort 1: Stannsoporfin 1.5 mg/kg PhotoTherapy (as needed) Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed. Cohort 3: Stannsoporfin 4.5 mg/kg PhotoTherapy (as needed) Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed. Cohort 4: Placebo PhotoTherapy (as needed) Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed. Cohort 4: Placebo Placebo Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed. Cohort 2: Stannsoporfin 3.0 mg/kg PhotoTherapy (as needed) Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
- Primary Outcome Measures
Name Time Method Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. Baseline, 48 hours The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time \[(TSB - PT threshold/PT threshold) x 100%).
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population Baseline, 48 hrs Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
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
Arrowhead Regional Med Center
🇺🇸Colton, California, United States
Neonatal Department Warsaw Medical University
🇵🇱Warszawa, Poland
Hospital Vall D´Hebrón
🇪🇸Barcelona, Spain
Research Institute of Polish Mother's Health Center
🇵🇱Łódź, Poland
National Pediatric Specialized Hospital "OHMATDYT".
🇺🇦Kiev, Ukraine
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸La Coruña, Spain
Kapi'olani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, 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
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
🇺🇦Odessa, Ukraine
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
University Hospital Santiago de Compostela-L Coruna
🇪🇸Santiago de Compostela, Spain
UCSD Medical Center
🇺🇸San Diego, California, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
ECU Brody School of Medicine
🇺🇸Greenville, North Carolina, United States
Drexel University College of Medicine, Clinical Research Group
🇺🇸Philadelphia, Pennsylvania, United States
St. Vincent Mercy Children's Hospital
🇺🇸Toledo, Ohio, United States
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
🇺🇦Kiev, Ukraine
University of Louisville
🇺🇸Louisville, Kentucky, United States