The primary objective of this clinical trial is to assess the safety and efficacy of stannsoporfin in combination with PT in term and near-term neonates.
• Percent change from baseline in TSB (the baseline TSB is the TSB that qualifies for randomization) at 6, 12, 18, 24, 30 and 36 hours
• Total serum bilirubin area under the curve (AUC) above the baseline TSB (0 to 48 hours post-dose)
• Peak serum bilirubin.
• Incidence of rebound hyperbilirubinemia defined as an increase in TSB above the age- specific threshold for initiating PT following the discontinuation of the initial PT
• Incidence of readmission to hospital for hyperbilirubinemia due to a TSB at or above the age specific threshold for PT
• Duration of clinical requirement for PT defined as the interval between the initiation of PT and the first transcutaneous bilirubin (TcB) measurement that is below the age specific threshold for PT. A TSB will be drawn and must also be below the age specific threshold for PT. The prior TcB will be used as the end of the need for PT.
• Safety outcome measures are:
•Incidence of adverse events and serious adverse events (SAE’s)
• Changes in vital sign measurements
• Results of physical exam (PE)
• Results of neurologic exam
• ECG assessments