At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Phototherapy, Stannsoporfin, and 1 other intervention for Jaundice, Neonatal and Hyperbilirubinemia, Neonatal. Completed, enrolled 91 participants across 18 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Phototherapy starts within 30 minutes before or after injection
Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)
Matching placebo administered by IM injection