NCT02685137

Efficacy and Safety of Stannsoporfin in Neonates

A Multicenter Study to Evaluate the Efficacy and Safety of Tin Mesoporphyrin (Stannsoporfin) to Reduce the Need for Phototherapy in Term and Near Term Infants.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company · Industry
• Sex: All
• Age: 12 Hours – 36 Hours
• Healthy volunteers: Not accepted

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".

Detailed description

For purposes of analysis, 2 patient populations are defined. One population consists of those babies who did not develop severe hyperbilirubinemia (TSB \<9 mg/dL) during the first 36 hours of age. This population is referred to as the untreated population of screened but not randomized patients. The second population of babies was defined as those infants who develop severe hyperbilirubinemia. These infants were randomized to treatment with either stannsoporfin or the sham injection and will be the focus of the efficacy and safety analysis. This population was referred to as the treated population. The treated population was used for the efficacy and safety analysis. These infants were randomized to either stannsoporfin or the sham injection treatment group.

Conditions

• Nutritional and Metabolic Diseases

Interventions

Type	Name	Description
DRUG	stannsoporfin	Intramuscular injection of stannsoporfin to treat jaundice.
OTHER	Sham Injection	nothing

Timeline

• Start date: 2002-05-01
• Primary completion: 2003-03-16
• Completion: 2013-02-01
• First posted: 2016-02-18
• Last updated: 2019-10-29

Locations

1 site across 1 country: United States