A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

InfaCare Pharmaceutical Corporation, 8 Neshaminy Interplex, Suite 221Trevose, PA 19053-6944, USA0 个研究点目标入组 72 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Term and late preterm subjects
•2. Risk factors for hemolytic disease to include ABO blood type incompatibility or Rh incompatibility (anti-C, c, D, E, or e)
•3. A minimum birth weight of 2500 g (5.5 lbs)
•4. Within 2 mg/dL below the 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

•1. Family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
•2. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto?s disease is not exclusionary)
•3. 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
•4. Risk factors for porphyrias, including family history
•5. Apgar score ≤6 at age 5 minutes
•6. Significant congenital anomalies or infections
•7. Cardiorespiratory distress
•8. Any abnormal auditory or ophthalmologic findings
•9. Any excess risk of requiring surgery or exposure to operating room lights in the foreseeable future
•10. Clinically significant abnormalities on screening laboratory evaluation
•11. Use of photosensitizing drugs or agents
•12. Use of intravenous immunoglobulin (IVIG) or albumins
•13. Other serious morbid conditions, eg, pulmonary disease, cardiovascular disease

发起方

InfaCare Pharmaceutical Corporation, 8 Neshaminy Interplex, Suite 221Trevose, PA 19053-6944, USA