Clinical trial NCT00850993: A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hyperbilirubinemia, Neonatal
Keywords: Hemolysis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sequential experimental cohorts are run in parallel with placebo controls.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment.
timeFrame: Baseline, 48 hours
measure: Change From Baseline in Total Serum Bilirubin (TSB) at 48 Hours (ITT Population
timeFrame: Baseline, 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Med Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
city: Honolulu
country: United States
facility: Kapi'olani Medical Center for Women and Children
state: Hawaii
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Greenville
country: United States
facility: ECU Brody School of Medicine
state: North Carolina
city: Toledo
country: United States
facility: St. Vincent Mercy Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine, Clinical Research Group
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Bydgoszcz
country: Poland
facility: Jan Bizel University Hospital No. 2; Department of Neonatal, Preemies and Neonatal Intensive Care
city: Warszawa
country: Poland
facility: Neonatal Department Warsaw Medical University
city: Łódź
country: Poland
facility: Research Institute of Polish Mother's Health Center
city: Barcelona
country: Spain
facility: Hospital Vall D´Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital La Paz
city: Santiago de Compostela
country: Spain
facility: University Hospital Santiago de Compostela-L Coruna
city: Chernivtsi
country: Ukraine
facility: 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
city: Kiev
country: Ukraine
facility: National Pediatric Specialized Hospital "OHMATDYT".
city: Kiev
country: Ukraine
facility: State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
city: Odessa
country: Ukraine
facility: 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
city: Vinnitsa
country: Ukraine
facility: Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: