A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

October 25, 2019 updated by: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bydgoszcz, Poland, 85-168
        • Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care
      • Warszawa, Poland, 00-315
        • Neonatal Department Warsaw Medical University
      • Łódź, Poland, 93-338
        • Research Institute of Polish Mother's Health Center
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall D´Hebron
      • Barcelona, Spain, E-08036
        • Hospital Clinic i Provincial
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28041
        • Hospital Doce de Octubre
      • Santiago de Compostela, Spain, 15706
        • University Hospital Santiago de Compostela-L Coruna
  • Ukraine
      • Chernivtsi, Ukraine, 58023
        • 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
      • Kiev, Ukraine, 1135
        • National Pediatric Specialized Hospital "OHMATDYT".
      • Kiev, Ukraine, 4050
        • State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
      • Odessa, Ukraine, 65031
        • 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
      • Vinnitsa, Ukraine, 21029
        • Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1
  • United States
    • California
      • Colton, California, United States, 92324
        • Arrowhead Regional Med Center
      • San Diego, California, United States, 92103
        • UCSD Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapi'olani Medical Center for Women and Children
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University Of Louisville
    • New York
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Brody School of Medicine
    • Ohio
      • Toledo, Ohio, United States, 43608
        • St. Vincent Mercy Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine, Clinical Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Stannsoporfin 1.5 mg/kg
Participants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed.
Drug: Stannsoporfin
Stannsoporfin administered as a single IM injection
Other Names:
  • Experimental product
Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Names:
  • PT
Experimental: Cohort 2: Stannsoporfin 3.0 mg/kg
Participants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Drug: Stannsoporfin
Stannsoporfin administered as a single IM injection
Other Names:
  • Experimental product
Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Names:
  • PT
Experimental: Cohort 3: Stannsoporfin 4.5 mg/kg
Participants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Drug: Stannsoporfin
Stannsoporfin administered as a single IM injection
Other Names:
  • Experimental product
Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Names:
  • PT
Placebo Comparator: Cohort 4: Placebo
Participants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.
Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Names:
  • PT
Other: Placebo
Placebo (sterile saline solution) administered as a single IM injection
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
Time Frame: Baseline, 48 hours
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
Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
Time Frame: Baseline, 48 hrs
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 25, 2019

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64,185-202
  • 2009-017434-45 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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