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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion
National hospital of pediatrics
Hanoi, Vietnam
Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters
Time frame: 30 days with long term f/u
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