A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Hyperbilirubinemia, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00850993
• Other study ID #: 64,185-202
• Secondary ID: 2009-017434-45
• Status: Terminated
• Phase: Phase 2
• Start date: August 2008
• Est. completion date: May 2012

Study information

• Verified date: August 2014
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: May 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

Inclusion Criteria:

Babies may only participate if they meet all the following criteria:

• Is a term or late preterm baby

• Is at risk for protocol-defined hemolytic disease

• Weighs at least 2500 g (5.5 lbs)

• Has total serum bilirubin (TSB) a specified amount lower than the phototherapy threshold for the age

• Has parents/guardians who are willing to follow light precautions and sign informed consent

Exclusion Criteria:

The following criteria will make a baby not eligible to participate:

• Needs medications that may prolong the QT interval

• Has family history or risk factors for Long QT Syndrome, Sudden Infant Death Syndrome, or Porphyrias

• Has an Apgar score of 6 or below at age 5 minutes

• Has abnormalities or infections (in mother or child) that per protocol or in the opinion of the investigator may compromise the safety and well-being of the baby or analysis of study results

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

Intervention

Drug:
• Stannsoporfin
Stannsoporfin administered as a single IM injection

Other:
• Placebo
Placebo (sterile saline solution) administered as a single IM injection
• PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period

Locations

Country	Name	City	State
Poland	Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care	Bydgoszcz
Poland	Research Institute of Polish Mother's Health Center	Lódz
Poland	Neonatal Department Warsaw Medical University	Warszawa
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital Vall D´Hebrón	Barcelona
Spain	Complejo Hospitalario Universitario A Coruña	La Coruña
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital La Paz	Madrid
Spain	University Hospital Santiago de Compostela-L Coruna	Santiago de Compostela
Ukraine	Municipal Medical Institution "Regional pediatric clinical hospital #1", Department of pathology of the newborns; Bukovynian State Medical University, Department of Pediatrics and Children's Infectious Diseases	Chernivtsi
Ukraine	National Pediatric Specialized Hospital "OHMATDYT".	Kiev
Ukraine	State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department	Kiev
Ukraine	Municipal Institution "Odessa regional clinical hospital", Department of pathology of the newborns and premature infants; Odessa State Medical University; Chair of Pediatrics #1 and Neonatology	Odessa
Ukraine	Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1	Vinnitsa
United States	Arrowhead Regional Med Center	Colton	California
United States	ECU Brody School of Medicine	Greenville	North Carolina
United States	Kapi'olani Medical Center for Women and Children	Honolulu	Hawaii
United States	University of Louisville	Louisville	Kentucky
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Drexel University College of Medicine, Clinical Research Group	Philadelphia	Pennsylvania
United States	UCSD Medical Center	San Diego	California
United States	St. Vincent Mercy Children's Hospital	Toledo	Ohio
United States	Westchester Medical Center	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Countries where clinical trial is conducted

United States,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.	The adjusted TSB is a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the American Academy of Pediatrics (AAP) Guidelines, ie, an indication of the distance below the PT threshold at the time [(TSB - PT threshold/PT threshold) x 100%).	Baseline, 48 hours
Primary	Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population	Total bilirubin in blood serum was measured at baseline and at 48 hours after the shot. Change from baseline is calculated by subtracting the amount at baseline from the amount at 48 hours. Lower numbers are better.	Baseline, 48 hrs