Efficacy and Safety of Stannsoporfin in Neonates

Phase 3

Completed

• Conditions: Nutritional and Metabolic Diseases
• Interventions: Other: Sham Injection; Drug: stannsoporfin

• Registration Number: NCT02685137
• Lead Sponsor: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

Brief 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.

Study Timeline

• Study Start: 2002-05-01
• Primary Completion: 2003-03-16
• Study Completion: 2013-02
• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Status Verified: 2018-06
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference Therapy-Sham	Sham Injection	Sham Injection, no injection followed by a Band-Aid to thigh
Active drug-Stannsoporfin	stannsoporfin	Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice 20 mg/mL 1.5 mL/vial

Primary Outcome Measures

Name	Time	Method
Need for Phototherapy	30 days	proportion of cases which need phototherapy in the treated population

Secondary Outcome Measures

Name	Time	Method
hyperbilirubinemia	12 hrs	Change in serum bilirubin values

Trial Locations

Locations (1)

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States