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Efficacy and Safety of Stannsoporfin in Neonates

NCT02685137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2019-10-29

No results posted yet for this study

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".

Conditions

  • Nutritional and Metabolic Diseases

Interventions

DRUG

stannsoporfin

Intramuscular injection of stannsoporfin to treat jaundice.

OTHER

Sham Injection

nothing

Sponsors & Collaborators

  • InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Hours
Max Age
36 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-01
Primary Completion
2003-03-16
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685137 on ClinicalTrials.gov