EUCTR2009-017434-45-PL进行中（未招募）1 期
A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with Hyperbilirubinemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Term and late preterm subjects (>=35 and <43 weeks gestational age)
- •2. Risk factors for hemolytic disease including ABO blood type incompatibility, Rh
- •incompatibility (anti-C, c, D, E, or e), or G6PD deficiency.
- •3. A minimum birth weight of 2500 g (5.5 lbs)
- •4. Coombs positive, or Coombs negative
- •- If Coombs negative, one or more of the following risk factors must also be
- •present. These include:
- •-Jaundice observed in the first 24 hours
- •-Previous sibling received phototherapy
- •-Cephalohematoma or significant bruising
- •-Exclusive breastfeeding
- •5. Serum bilirubin within 2 mg/dL below the threshold for PT up to 12 hours of age or within 3 mg/dL below the threshold for PT at =12 to 72 hours of age, inclusive
- •Note: TcB monitoring may be used for screening purposes, however randomization/treatment cannot take place until the TSB is within 2-3 mg/dL of
- •the PT threshold based on age
- •6. Willingness for parents/guardians to adhere to recommendations regarding light
- •precautions
- •7. Written informed consent obtained from parents/guardians
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 72
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimotos disease is not exclusionary)
- •2. Treatment or need for treatment in the neonate with medications that may prolong the QT interval (see Appendix C) (erythromycin ointment for eye prophylaxis is permitted), family history of Long QT syndrome or family history of Sudden Infant
- •Death syndrome
- •3. Known porphyrias or risk factors for porphyrias, including family history
- •4. A maternal history of systemic lupus erythematosus
- •5. Maternal use of phenobarbital 30 days before, or after delivery, if breast-feeding
- •6. 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 subject a suitable
- •candidate for participation in the clinical trial
- •7. Apgar score =< 6 at age 5 minutes
- •8 Significant congenital anomalies or infections
- •9. Cardiorespiratory distress, defined as a respiratory rate >60 breaths per minute at time of enrollment unless a diagnosis of transient tachypnea of the newborn (TTN) has been made
- •10. Any abnormal auditory or ophthalmologic findings at Screening
- •- Subjects who fail initial auditory screen may be rescreened
- •11. Any excess risk of requiring surgery or exposure to operating room (OR) lights in the foreseeable future
- •12. Clinically significant abnormalities on screening laboratory evaluation
- •13. Elevated direct or conjugated bilirubin (>1.0 mg/dL if the TSB is <5.0 mg/dL or
- •>20% of the TSB if the TSB is >= 5.0 mg/dL)
- •14. Persistent hypoglycemia (blood glucose <40 mg/dL) despite standard-of-care
- •15. Alanine aminotransferase and/or aspartate aminotransferase > 2 times the ULN
- •16. Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN
- •17. Any blood smear finding of structural red cell abnormalities, such as spherocytosis, not caused by isoimmune hemolysis
- •18. Temperature instability defined as temperature consistently (3 consecutive times)
- •<36ºC and/or >37.5ºC axillary
- •19. Use of photosensitizing drugs or agents (see Appendix D)
- •20. Use of IVIG or albumins
- •21. Postdelivery treatment with medications that are known or suspected to displace
- •bilirubin from albumin (eg, ceftriaxone or sulfa-based antibiotics)
- •22. Other serious morbid conditions, e.g., pulmonary disease, cardiovascular disease
- •23. Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial;
- •24. Any other concurrent medical condition, which in the opinion of the Investigator,
- •makes the subject unsuitable for the clinical trial
- •25. Unwillingness for parents/guardians to adhere to recommendations regarding light precautions
研究者
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