A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Inclusion Criteria:

• Term and late preterm subjects
• Risk factors for hemolytic disease to include ABO blood type incompatibility or Rh incompatibility (anti-C, c, D, E, or e, or G6PD deficiency
• A minimum birth weight of 2500 g (5.5 lbs)
• Enrollment within 2 mg/dL below the TSB threshold for PT per the AAP Guidelines at up to 12 hours of age or within 3 mg/dL below the threshold for PT at >12 to 48 hours of age, inclusive
• Randomization and treatment cannot take place until the infant is within 1 mg/dl below the threshold for PT per the AAP Guidelines at up to 12 hours of age or within 2 mg/dL below the threshold for PT at >12 to 48 hours of age, inclusive

Exclusion Criteria:

• Treatment or need for treatment in the neonate with medications that may prolong the QT interval, family history of Long QT syndrome or family history of Sudden Infant Death Syndrome
• Risk factors for porphyrias, including family history
• Apgar score ≤6 at age 5 minutes
• Significant congenital anomalies or infections
• Cardiorespiratory distress
• Any abnormal auditory or ophthalmologic findings
• Any excess risk of requiring surgery or exposure to operating room lights in the foreseeable future
• Clinically significant abnormalities on screening laboratory evaluation
• Use of photosensitizing drugs or agents
• Use of intravenous immunoglobulin (IVIG) or albumins
• Other serious morbid conditions, eg, pulmonary disease, cardiovascular disease