A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
NCT ID: NCT00850993
Last Updated: 2019-10-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
58 participants
INTERVENTIONAL
2008-08-31
2012-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The research pharmacy and the health care provider responsible for giving the injection to patients knew what the treatment was (they were not blinded).
Study Groups
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Cohort 1: Stannsoporfin 1.5 mg/kg
Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed.
Stannsoporfin
Stannsoporfin administered as a single IM injection
PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Cohort 2: Stannsoporfin 3.0 mg/kg
Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Stannsoporfin
Stannsoporfin administered as a single IM injection
PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Cohort 3: Stannsoporfin 4.5 mg/kg
Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Stannsoporfin
Stannsoporfin administered as a single IM injection
PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Cohort 4: Placebo
Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.
Placebo
Placebo (sterile saline solution) administered as a single IM injection
PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Interventions
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Stannsoporfin
Stannsoporfin administered as a single IM injection
Placebo
Placebo (sterile saline solution) administered as a single IM injection
PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
1 Minute
48 Hours
ALL
No
Sponsors
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
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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
Countries
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Other Identifiers
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2009-017434-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64,185-202
Identifier Type: -
Identifier Source: org_study_id