An Open-Label Study of the Safety and Clinical Pharmacology of Stanate® in Infants At-Risk for Exchange Transfusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters
研究概览
简要总结
The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.
详细描述
The present study evaluated the relationship between Stanate® dose, drug safety, and efficacy in a non randomised sequential open label cohort design, in 55 patients. Subjects were term and near term infants at medium or high risk of hyperbilirubinemia with TSB levels approaching the threshold for exchange transfusion. The first cohort began at a dose of stannsoporfin 0.75 mg/kg of birth weight intramuscularly. The dose was then increased to 1.5 mg/kg for cohort 2, and saline was given (placebo) for cohort 3. Safety evaluations consisted of hepatic, renal and hematologic clinical laboratory tests along with serial physical examinations. Long term follow up of all patients to age 6 is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Days 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term and near-term healthy infants (may be no more than 14 days of age) with excessive hyperbilirubinemia who are at risk for exchange transfusion according to the AAP guidelines of 2004
排除标准
- •No parental consent
- •Major known congenital anomaly
- •Current use of antibiotics, cardio-respiratory instability, abnormal renal function, hepatitis (as related to TORCH infections)
- •Phenobarbital use in either child or mother (30 days prior to child's birth)
研究组 & 干预措施
1
stannsoporfin 0.75mg/kg
干预措施: Stanate (Drug)
2
stannsoporfin 1.5mg/kg
干预措施: Stanate (Drug)
3
saline injection
干预措施: Stanate (Drug)
结局指标
主要结局
Reduction of serum bilirubin levels; need for exchange transfusion, safety parameters
时间窗: 30 days with long term f/u
次要结局
未报告次要终点