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A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

NCT00850993 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-10-30

Study results available
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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.

Conditions

  • Hyperbilirubinemia, Neonatal

Interventions

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

Sponsors & Collaborators

  • InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-06-30
Completion
2012-05-31

Countries

  • United States
  • Poland
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850993 on ClinicalTrials.gov