A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

This study has been terminated.
(To redefine study population)
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00850993
First received: February 24, 2009
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Hyperbilirubinemia, Neonatal
Drug: stannsoporfin
Other: Saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by InfaCare Pharmaceuticals Corporation:

Primary Outcome Measures:
  • The Primary Efficacy Endpoint Was the Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. [ Time Frame: 48 hours after injection ] [ Designated as safety issue: No ]

    The primary efficacy endpoint was the change in adjusted TSB from baseline to 48 hours after treatment.

    The adjusted Total Serum Bilirubin (TSB) was a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the AAP Guidelines, ie, an indication of the distance below the PT threshold at the time.



Secondary Outcome Measures:
  • Change From Baseline in Unadjusted Total Serum Bilirubin (TSB) at 48 Hours (ITT Population [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
    Change from Baseline in Unadjusted TSB at 48 Hours (ITT Population)


Enrollment: 63
Study Start Date: August 2008
Study Completion Date: May 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stannsoporfin
3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
Drug: stannsoporfin
single IM injection of 1.5, 3.0, or 4.5 mg/kg
Placebo Comparator: Placebo (Saline)
Cohort of approximately 24 subjects will be recruited.
Other: Saline
Normal saline (0.9%) solution

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term and late preterm subjects
  • Risk factors for hemolytic disease to include ABO blood type incompatibility or Rh incompatibility (anti-C, c, D, E, or e, or G6PD deficiency
  • A minimum birth weight of 2500 g (5.5 lbs)
  • Enrollment within 2 mg/dL below the Total Serum Bilirubin (TSB) threshold for PhotoTherapy (PT) per the AAP Guidelines at up to 12 hours of age or within 3 mg/dL below the threshold for PhotoTherapy (PT) at >12 to 48 hours of age, inclusive
  • Randomization and treatment cannot take place until the infant is within 1 mg/dl below the threshold for PhotoTherapy (PT) per the American Association Pediatrics (AAP) Guidelines at up to 12 hours of age or within 2 mg/dL below the threshold for PT at >12 to 48 hours of age, inclusive

Exclusion Criteria:

  • Treatment or need for treatment in the neonate with medications that may prolong the QT interval, family history of Long QT syndrome or family history of Sudden Infant Death Syndrome
  • Risk factors for porphyrias, including family history
  • Apgar score ≤6 at age 5 minutes
  • Significant congenital anomalies or infections
  • Cardiorespiratory distress
  • Any abnormal auditory or ophthalmologic findings
  • Any excess risk of requiring surgery or exposure to operating room lights in the foreseeable future
  • Clinically significant abnormalities on screening laboratory evaluation
  • Use of photosensitizing drugs or agents
  • Use of intravenous immunoglobulin (IVIG) or albumins
  • Other serious morbid conditions, eg, pulmonary disease, cardiovascular disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850993

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

No publications provided

Responsible Party: InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00850993     History of Changes
Other Study ID Numbers: 64,185-202, 2009-017434-45
Study First Received: February 24, 2009
Results First Received: December 6, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:
Hemolysis

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Pathologic Processes
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014