Efficacy and Safety of Stannsoporfin in Neonates

Nutritional and Metabolic Diseases Clinical Trial

Official title: 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

Clinical Trial 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".

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases

• NCT number: NCT02685137
• Study type: Interventional
• Source: Mallinckrodt
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2002
• Completion date: February 2013