NCT00115544

Safety and Pharmacology of Stanate

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Industry
• Sex: All
• Age: 2 Days – 7 Days
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hyperbilirubinemia

Interventions

Type	Name	Description
DRUG	Stanate	Intramuscular injection of stannsoporfin at 0.75 or 1.5mg/kg for treatment of severe hyperbilirubinemia to prevent exchange transfusion

Timeline

• Start date: 2005-09-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2005-06-23
• Last updated: 2019-10-15

Locations

1 site across 1 country: Vietnam