Clinical Trial: Efficacy and Safety of Stannsoporfin in Neonates

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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.

Brief Summary: This is a randomized, sham-controlled (placebo) 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 Summary: The acute phase of this study is complete. Long term follow up extensoin study continues.
Sponsor: InfaCare Pharmaceuticals Corporation

Current Primary Outcome: need for phototherapy [ Time Frame: 30 days ]

proportion of cases which need phototherapy,


Original Primary Outcome: Same as current

Current Secondary Outcome: hyperbilirubinemia [ Time Frame: 12 hrs ]

Change in serum bilirubin values


Original Secondary Outcome: Same as current

Information By: InfaCare Pharmaceuticals Corporation

Dates:
Date Received: February 10, 2016
Date Started: April 2002
Date Completion:
Last Updated: February 12, 2016
Last Verified: January 2016