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A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

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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 : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

February 24, 2009
February 25, 2009
December 6, 2013
August 29, 2014
August 29, 2014
August 2008
June 2011   (Final data collection date for primary outcome measure)
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 ]

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.

To determine the safety of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemia. [ Time Frame: First 30 days after injection ]
Complete list of historical versions of study NCT00850993 on ClinicalTrials.gov Archive Site
Change From Baseline in Unadjusted Total Serum Bilirubin (TSB) at 48 Hours (ITT Population [ Time Frame: 48 hrs ]
Change from Baseline in Unadjusted TSB at 48 Hours (ITT Population)
To determine the efficacy and pharmacokinetics of 3 ascending doses of stannsoporfin [ Time Frame: Up to 14 days following injection ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperbilirubinemia, Neonatal
  • Drug: stannsoporfin
    single IM injection of 1.5, 3.0, or 4.5 mg/kg
  • Other: Saline
    Normal saline (0.9%) solution
  • 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.
    Intervention: Drug: stannsoporfin
  • Placebo Comparator: Placebo (Saline)
    Cohort of approximately 24 subjects will be recruited.
    Intervention: Other: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
63
72
May 2012
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 48 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Poland,   Spain,   Ukraine,   United States
 
 
NCT00850993
64,185-202
2009-017434-45 ( EudraCT Number )
Yes
Not Provided
Not Provided
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Not Provided
Principal Investigator: M. Jeffrey Maisels, MB, BCh William Beaumont Hospitals
InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP