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A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850993
Recruitment Status : Terminated (To redefine study population)
First Posted : February 25, 2009
Results First Posted : August 29, 2014
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt ( InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company )

Brief 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.


Condition or disease Intervention/treatment Phase
Hyperbilirubinemia, Neonatal Drug: Stannsoporfin Other: Placebo Other: PhotoTherapy (as needed) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Sequential experimental cohorts are run in parallel with placebo controls.
Masking: Double (Participant, Investigator)
Masking Description:

Clinical personnel at the site (including investigator, study coordinator and central cardiologist) were blinded to treatment group.

The research pharmacy and the health care provider responsible for giving the injection to patients knew what the treatment was (they were not blinded).

Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Study Start Date : August 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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 Name: Experimental product

Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Name: 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 Name: Experimental product

Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Name: 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 Name: Experimental product

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

Other: PhotoTherapy (as needed)
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Other Name: PT




Primary Outcome Measures :
  1. 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%).

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850993


Locations
Show Show 23 study locations
Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Investigators
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Study Director: Clinical Team Leader Mallinckrodt

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Responsible Party: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
ClinicalTrials.gov Identifier: NCT00850993    
Other Study ID Numbers: 64,185-202
2009-017434-45 ( EudraCT Number )
First Posted: February 25, 2009    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: October 30, 2019
Last Verified: August 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mallinckrodt ( InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company ):
Hemolysis
Additional relevant MeSH terms:
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Hyperbilirubinemia, Neonatal
Hyperbilirubinemia
Pathologic Processes
Infant, Newborn, Diseases
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action