A Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates with HyperbilirubinemiaEnsayo de fase 2b, multicéntrico, de dosis única, ciego, aleatorizado, controlado por placebo, con aumento escalonado de la dosis para comprobar la seguridad y la eficacia de la estansoporfina (Stanate®) en neonatos con hiperbilirrubinemia

• Conditions: eonatal hyperbilirubinemiaHiperbilirubinemia neonatal; MedDRA version: 12.1Level: LLTClassification code 10020580Term: Hyperbilirubinaemia neonatal

• Registration Number: EUCTR2009-017434-45-ES
• Lead Sponsor: InfaCare Pharmaceutical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

- Term and late preterm subjects (>=35 weeks and <43 weeks gestational age)
- Risk factors for hemolytic disease to include subjects with ABO blood type incompatibility or Rh incompatibility (anti-C, c, D, E, or e)
- A minimum birth weight of 2500 g (5.5 lbs)
- Coombs test results available
- Within 2 mg/dL below the threshold for PT per the AAP Guidelines (see Appendix A) 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 (see Appendix B)
- Willingness for parents/guardians to adhere to recommendations regarding light precautions
- Written informed consent obtained from parents/guardians
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Exclusion Criteria

- Family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Clinical suggestion of neonatal thyroid disease or current uncontrolled thyroid disease in the mother (maternal Hashimoto´s disease is not exclusionary)
- 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
- Known porphyrias or risk factors for porphyrias, including family history
- A maternal history of systemic lupus erythematosus
- Maternal use of phenobarbital 30 days before, or after delivery, if breastfeeding
- 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
- Apgar score =< 6 at age 5 minutes
- Significant congenital anomalies or infections
- Cardiorespiratory distress, defined as a respiratory rate >60 breaths per minute, at time of enrollment, unless a diagnosis of transient tachypnea of the newborn has been made
- Any abnormal auditory or ophthalmologic findings at Screening: Subjects who fail initial auditory screen may be rescreened
- Any excess risk of requiring surgery or exposure to operating room lights in the foreseeable future
- Clinically significant abnormalities on screening laboratory evaluation
- 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)
- Persistent hypoglycemia (blood glucose <40 mg/dL) despite standard-of-care treatment
- Alanine aminotransferase >2 times the upper limit of normal (ULN) or aspartate aminotransferase >3 times the ULN
- Abnormal renal function defined as creatinine and/or blood urea nitrogen >2 times the ULN
- Any blood smear finding of structural red cell abnormalities, such as spherocytosis, not caused by isoimmune hemolysis
- Temperature instability defined as temperature consistently (3 consecutive times) <36ºC and/or >37.5ºC axillary
- Use of photosensitizing drugs or agents (see Appendix D)
- Use of intravenous immunoglobulin (IVIG) or albumins
- Postdelivery treatment with medications that are known or suspected to displace bilirubin from albumin (eg, ceftriaxone or sulfa-based antibiotics)
- Other serious morbid conditions, eg, pulmonary disease, cardiovascular disease
- Exposure to any investigational medications or devices after delivery, or participation in another clinical trial while participating in this trial
- Any other concurrent medical condition that, in the opinion of the Investigator, makes the subject unsuitable for the clinical trial
- Unwillingness for parents/guardians to adhere to recommendations regarding light precautions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified