Safety and Pharmacology of Stanate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion

Conditions
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Hyperbilirubinemia

Intervention / Treatment
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* Drug: Stanate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>stannsoporfin 0.75mg/kg | Drug: Stanate<br>* Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion<br>|
| Experimental: 2<br>stannsoporfin 1.5mg/kg | Drug: Stanate<br>* Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion<br>|
| Placebo Comparator: 3<br>saline injection | Drug: Stanate<br>* Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters |  | 30 days with long term f/u | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal, jaundice, hyperbilirubinemia