NCT00850993

A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Industry
• Sex: All
• Age: 1 Minute – 48 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
DRUG	Stannsoporfin	Stannsoporfin administered as a single IM injection
OTHER	Placebo	Placebo (sterile saline solution) administered as a single IM injection
OTHER	PhotoTherapy (as needed)	PT standard care administered as needed, based on bilirubin levels throughout the treatment period

Timeline

• Start date: 2008-08-01
• Primary completion: 2011-06-01
• Completion: 2012-05-01
• First posted: 2009-02-25
• Last updated: 2019-10-30
• Results posted: 2014-08-29

Locations

23 sites across 4 countries: United States, Poland, Spain, Ukraine