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Safety and Pharmacology of Stanate

Hyperbilirubinemia Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00115544
Study type Interventional
Source Mallinckrodt
Contact
Status Completed
Phase Phase 2
Start date September 2005
Completion date July 2006
View Details
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