A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Phase 2

Terminated

Interventions: Drug: Stannsoporfin
Other: Placebo
Other: PhotoTherapy (as needed)

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

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

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

Locations (23): 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
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Arrowhead Regional Med Center
🇺🇸Colton, California, United States