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A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by InfaCare Pharmaceuticals Corporation.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00850993
First received: February 24, 2009
Last updated: June 10, 2011
Last verified: August 2010
History of Changes
  Purpose

The purpose of this study is to determine if an experimental drug, Stanate®, 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:

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Further study details as provided by InfaCare Pharmaceuticals Corporation:

Primary Outcome Measures:
  • To determine the safety of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemia. [ Time Frame: First 30 days after injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the efficacy and pharmacokinetics of 3 ascending doses of stannsoporfin [ Time Frame: Up to 14 days following injection ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: August 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stanate®
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 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 TSB threshold for PT per the AAP Guidelines at up to 12 hours of age or within 3 mg/dL below the threshold for 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 PT per the 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00850993

Contacts
Contact: Warren W. Wasiewski, M.D. 267.515.5861 wwasiewski@infacare.com

  Show 33 Study Locations
Sponsors and Collaborators
InfaCare Pharmaceuticals Corporation
Investigators
Principal Investigator: M. Jeffrey Maisels, MB, BCh William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Warren W. Wasiewski, M.D., Chief Medical Officer, 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
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by InfaCare Pharmaceuticals Corporation:
Hemolysis

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013