A Multicenter Study to Evaluate the Efficacy and Safety of Tin Mesoporphyrin (Stannsoporfin) to Reduce the Need for Phototherapy in Term and Near Term Infants.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Need for Phototherapy
研究概览
简要总结
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the well-baby nursery and enrolled with "intention to treat".
详细描述
For purposes of analysis, 2 patient populations are defined. One population consists of those babies who did not develop severe hyperbilirubinemia (TSB <9 mg/dL) during the first 36 hours of age. This population is referred to as the untreated population of screened but not randomized patients. The second population of babies was defined as those infants who develop severe hyperbilirubinemia. These infants were randomized to treatment with either stannsoporfin or the sham injection and will be the focus of the efficacy and safety analysis. This population was referred to as the treated population.
The treated population was used for the efficacy and safety analysis. These infants were randomized to either stannsoporfin or the sham injection treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 36 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Active drug-Stannsoporfin
Stannsoporfin, single dose 4.5mg/kg administered Intramuscular (parental injection in the thigh) for treatment of jaundice
20 mg/mL 1.5 mL/vial
干预措施: stannsoporfin (Drug)
Reference Therapy-Sham
Sham Injection, no injection followed by a Band-Aid to thigh
干预措施: Sham Injection (Other)
结局指标
主要结局
Need for Phototherapy
时间窗: 30 days
proportion of cases which need phototherapy in the treated population
次要结局
- hyperbilirubinemia(12 hrs)