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