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Safety and Pharmacology of Stanate

This study has been completed.
Sponsor:
Collaborator:
National Hospital of Pediatrics, Vietnam
Information provided by (Responsible Party):
InfaCare Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00115544
First received: June 22, 2005
Last updated: February 9, 2016
Last verified: February 2016

June 22, 2005
February 9, 2016
September 2005
July 2006   (final data collection date for primary outcome measure)
Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters [ Time Frame: 30 days with long term f/u ] [ Designated as safety issue: Yes ]
Reduction of serum bilirubin levels
Complete list of historical versions of study NCT00115544 on ClinicalTrials.gov Archive Site
Not Provided
Reduction of exhaled carbon monoxide
Not Provided
Not Provided
 
Safety and Pharmacology of Stanate
An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion
The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.
The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy in a non randomised sequential open label cohort design, in 55 patients. Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion. The first cohort began at a dose of stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5 mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted of hepatic, renal and hematologic clinical laboratory tests along with serial physical examinations. Long term follow up of all patients to age 6 is planned.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hyperbilirubinemia
Drug: Stanate
Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
  • Experimental: 1
    stannsoporfin 0.75mg/kg
    Intervention: Drug: Stanate
  • Experimental: 2
    stannsoporfin 1.5mg/kg
    Intervention: Drug: Stanate
  • Placebo Comparator: 3
    saline injection
    Intervention: Drug: Stanate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004

Exclusion Criteria:

  • No parental consent
  • Major known congenital anomaly
  • Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
  • Phenobarbital use in either child or mother (30 days prior to child's birth)
Both
up to 7 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Vietnam
United States
 
NCT00115544
64,185-06-2W, no grant or contracts
Yes
Not Provided
Not Provided
InfaCare Pharmaceuticals Corporation
InfaCare Pharmaceuticals Corporation
National Hospital of Pediatrics, Vietnam
Not Provided
InfaCare Pharmaceuticals Corporation
February 2016

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