A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Phase 2TerminatedNCT00850993

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company58 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hyperbilirubinemia, Neonatal

Interventions

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 48 Hours

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.

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%).

Time frame: Baseline, 48 hours

Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population

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.

Time frame: Baseline, 48 hrs