drugset / Trial / NCT01887327

Stannsoporfin With Light Therapy for Newborn Babies With Jaundice

NCT01887327

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2013-10-16
Primary completion
2016-03-22
Completion
2016-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject stannsoporfin Small molecule 3 mg/kg Intramuscular
Subject stannsoporfin Small molecule 4.5 mg/kg Intramuscular

Indications