Clinical Trial: A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Brief Summary: The purpose of this study is to determine if an experimental drug, stannsoporfin, is safe and effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
Detailed Summary:
Sponsor: InfaCare Pharmaceuticals Corporation
Current Primary Outcome: The Primary Efficacy Endpoint Was the Change in Adjusted Total Serum Bilirubin (TSB) From Baseline to 48 Hours After Treatment. [ Time Frame: 48 hours after injection ]
The primary efficacy endpoint was the change in adjusted TSB from baseline to 48 hours after treatment.
The adjusted Total Serum Bilirubin (TSB) was a calculation of the percentage difference of the TSB level from the age-specific threshold for PT initiation per the AAP Guidelines, ie, an indication of the distance below the PT threshold at the time.
Original Primary Outcome: To determine the safety of 3 ascending doses of stannsoporfin in subjects with hyperbilirubinemia. [ Time Frame: First 30 days after injection ]
Current Secondary Outcome: Change From Baseline in Unadjusted Total Serum Bilirubin (TSB) at 48 Hours (ITT Population [ Time Frame: 48 hrs ]
Original Secondary Outcome: To determine the efficacy and pharmacokinetics of 3 ascending doses of stannsoporfin [ Time Frame: Up to 14 days following injection ]
Information By: InfaCare Pharmaceuticals Corporation
Dates:
Date Received: February 24, 2009
Date Started: August 2008
Date Completion:
Last Updated: August 19, 2014
Last Verified: August 2014