Hyperbilirubinemia, Neonatal Clinical Trial
Official title:
A Phase 2b Multicenter, Single Dose, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates
It is normal for red blood cells to die, even in newborn babies. The waste from that is
called bilirubin. The liver clears bilirubin out of the body.
Some babies are born with illness that makes red blood cells die too fast, so the liver is
not strong enough to keep up with it.
The yellowish color in eyes or skin means there is too much bilirubin in the body. It can be
dangerous if a baby's bilirubin gets too high.
Special lights are put on jaundiced babies (called phototherapy) to help the liver get rid of
bilirubin.
This study tests an experimental drug to see if it can help the liver even more, by safely
cutting down the amount of bilirubin the body is making in the first place.
Participants randomized (1:1:1) to treatment groups will be term or near-term infants with isoimmune hemolytic disease or glucose-6-phosphate dehydrogenase (G6PD) deficiency. ;
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