Study Stopped
To redefine study population
A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
2 other identifiers
interventional
58
4 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
Typical duration for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 24, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
August 29, 2014
CompletedOctober 30, 2019
August 1, 2014
2.8 years
February 24, 2009
December 6, 2013
October 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (4)
Cohort 1: Stannsoporfin 1.5 mg/kg
EXPERIMENTALParticipants receive a single dose of 1.5 mg/kg by intramuscular (IM) injection, along with PhotoTherapy (PT) if and when needed.
Cohort 2: Stannsoporfin 3.0 mg/kg
EXPERIMENTALParticipants receive a single dose of 3.0 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Cohort 3: Stannsoporfin 4.5 mg/kg
EXPERIMENTALParticipants receive a single dose of 4.5 mg/kg by intramuscular (IM) injection, along with PT if and when needed.
Cohort 4: Placebo
PLACEBO COMPARATORParticipants receive a single dose of placebo (sterile saline solution) by IM injection, along with PT if and when needed.
Interventions
Stannsoporfin administered as a single IM injection
Placebo (sterile saline solution) administered as a single IM injection
PT standard care administered as needed, based on bilirubin levels throughout the treatment period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Arrowhead Regional Med Center
Colton, California, 92324, United States
UCSD Medical Center
San Diego, California, 92103, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
ECU Brody School of Medicine
Greenville, North Carolina, 27834, United States
St. Vincent Mercy Children's Hospital
Toledo, Ohio, 43608, United States
Drexel University College of Medicine, Clinical Research Group
Philadelphia, Pennsylvania, 19102, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care
Bydgoszcz, 85-168, Poland
Research Institute of Polish Mother's Health Center
Lodz, 93-338, Poland
Neonatal Department Warsaw Medical University
Warsaw, 00-315, Poland
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Vall D´Hebrón
Barcelona, 08035, Spain
Hospital Clinic i Provincial
Barcelona, E-08036, Spain
Hospital Doce de Octubre
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
University Hospital Santiago de Compostela-L Coruna
Santiago de Compostela, 15706, Spain
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, 58023, Ukraine
National Pediatric Specialized Hospital "OHMATDYT".
Kiev, 1135, Ukraine
State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
Kiev, 4050, 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
Odesa, 65031, 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, 21029, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
It should be noted that the study was discontinued before enrollment of the full 4.5 mg/kg cohort,and therefore, the stannsoporfin 4.5 mg/kg treatment group included 8 patients and the placebo group included 15 patients.
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- 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).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2009
First Posted
February 25, 2009
Study Start
August 1, 2008
Primary Completion
June 1, 2011
Study Completion
May 1, 2012
Last Updated
October 30, 2019
Results First Posted
August 29, 2014
Record last verified: 2014-08
Data Sharing
- IPD Sharing
- Will not share