NCT01887327

Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Industry
• Sex: All
• Age: 1 Hour – 72 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Jaundice, Neonatal
• Hyperbilirubinemia, Neonatal

Interventions

Type	Name	Description
PROCEDURE	Phototherapy	Phototherapy starts within 30 minutes before or after injection
DRUG	Stannsoporfin	Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)
DRUG	Placebo	Matching placebo administered by IM injection

Timeline

• Start date: 2013-10-16
• Primary completion: 2016-03-22
• Completion: 2016-03-22
• First posted: 2013-06-26
• Last updated: 2020-02-06
• Results posted: 2019-11-13

Locations

18 sites across 1 country: United States