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Клинические исследования в Украине

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Описание
Краткое названиеA Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
Полное названиеA Phase 2b, Multicenter, Single-dose, Blinded, Randomized, Placebo-controlled, Dose-escalation, Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia
СпонсорInfaCare Pharmaceuticals Corporation
Industry
ИсточникInfaCare Pharmaceuticals Corporation
Под контролемUnited States: Food and Drug Administration
Yes
Краткое описаниеThe purpose of this study is to determine if an experimental drug, Stanate?®, is safe and
effective in the treatment of hyperbilirubinemia in hemolyzing neonates.
СостояниеИдет набор
Дата началаAugust 2008
ФазаPhase 2
Вид исследованияAllocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Набор0
КритерииInclusion 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
ПолBoth
Минимальный возрастN/A
Максимальный возраст48 Hours
УсловиеHyperbilirubinemia, Neonatal
Применяемое лечение
Drugstannsoporfin
OtherSaline
Контакты и расположение
Chernivtsi , 58023Municipal Medical Institution "Regional pediatric clinical hospital #1", Department of pathology of the newborns; Bukovynian State Medical University, Department of Pediatrics and Children's
Kiev , 1135National Pediatric Specialized Hospital "OHMATDYT".
Kiev , 4050State Institution "Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of the Ukraine", Neonatology Department
Odessa , 65031Municipal Institution "Odessa regional clinical hospital", Department of pathology of the newborns and premature infants; Odessa State Medical University; Chair of Pediatrics #1 and Neonatol
Vinnitsa , 21029Vinnytsia regional pediatric hospital, Department of pathology of the newborns, Vinnytsia National Medical University named after M.I.Pirogov, Chair of Pediatrics #1
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