Study Evaluating the Safety and Efficacy of Two Doses of Stannsoporfin in Combination With Phototherapy in Neonates With Hyperbilirubinemia

Inclusion Criteria:

1. Term and near term infants ≥35 and ≤ 43 weeks GA, age 0-48 hours with ABO or Rh
incompatibility (anti C, c, D, E or e) who are Coombs positive, or age 0-72 hours
with G6PD deficiency

2. Parental or guardian consent

3. Birth weight ≥ 2500 grams

4. At or above the age-specific threshold for initiating PT per the AAP guidelines based
on measurement of TSB

5. Parents agree to observe light precautions for 10 days post treatment

Exclusion Criteria:

1. Elevated direct bilirubin ≥2 mg/dL, OR > 20% of the total serum bilirubin 2. Alanine
aminotransferase (ALT) > 2 times the upper limit of normal (ULN) and/or aspartate
aminotransferase (AST) > 3 times ULN 3. Abnormal renal function defined as creatinine
and/or blood urea nitrogen >2 times the ULN 4. Any other clinically significant
abnormalities on screening laboratory evaluation (including ECG) that in the opinion of
the investigator makes the patient unsuitable for the clinical trial 5. Apgar score ≤6 at
age 5 minutes 6. An unexplained existing rash or skin erythema 7. Prior exposure to PT 8.
Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in
the mother (maternal Hashimoto's disease is not exclusionary) 9. Cardio-respiratory
distress, defined as a respiratory rate >60 breaths per minute at time of enrollment 10.
Any abnormal auditory or ophthalmologic findings on screening physical exam 11. Treatment
or need for treatment in the neonate with medications that are photoreactive or may
prolong the QT interval (erythromycin ointment for eye prophylaxis is permitted), or
family history of Long QT syndrome QT syndrome (appendix C) 12. Known porphyrias or risk
factors for porphyrias, including family history 13. A maternal history of systemic lupus
erythematosus 14. Maternal use of phenobarbital 30 days before, or after delivery, if
breast-feeding 15. Maternal current drug or alcohol abuse, or maternal history of drug or
alcohol abuse that, in the opinion of the Investigator, would not make the patient a
suitable candidate for participation in the clinical trial 16. Significant congenital
anomalies or infections 17. Risk of requiring surgery or exposure to operating room (OR)
lights in the first 2 weeks of life 18. Persistent hypoglycemia (blood glucose <40 mg/dL)
19. Temperature instability defined as temperature consistently (3 consecutive times)
<36ºC and/or >37.5ºC axillary 20. Use of IVIG or albumin prior to study drug
administration 21. Post-delivery treatment with medications that are known or suspected to
displace bilirubin from albumin (e.g., ceftriaxone or sulfa-based antibiotics) 22. Use of
photosensitizing drugs or agents (appendix D) 23. Unwillingness for parents/guardians to
adhere to recommendations regarding light precautions 24. Exposure to any investigational
medications or devices after delivery, or participation in another clinical trial while
participating in this trial 25. Any other concurrent medical condition, which in the
opinion of the Investigator, makes the patient unsuitable for the clinical trial