drugset / Trial / NCT02685137

Efficacy and Safety of Stannsoporfin in Neonates

NCT02685137

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".

Timeline

Start
2002-05-01
Primary completion
2003-03-16
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject stannsoporfin Small molecule 4.5 mg/kg Intramuscular

Indications