A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).
No interventions were administered during this follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Days 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup
排除标准
- •Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent
研究组 & 干预措施
Cohort 1: Stannsoporfin 1.5 mg/kg
Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Phototherapy (as needed) (Other)
Cohort 2: Stannsoporfin 3.0 mg/kg
Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Stannsoporfin (Drug)
Cohort 2: Stannsoporfin 3.0 mg/kg
Cohort 2: Received one 3.0 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Phototherapy (as needed) (Other)
Cohort 1: Stannsoporfin 1.5 mg/kg
Cohort 1: Received one 1.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Stannsoporfin (Drug)
Cohort 3: Stannsoporfin 4.5 mg/kg
Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Stannsoporfin (Drug)
Cohort 3: Stannsoporfin 4.5 mg/kg
Cohort 3: Received one 4.5 mg/kg stannsoporfin injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Phototherapy (as needed) (Other)
Cohort 4: Placebo Control
Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Placebo Control (Drug)
Cohort 4: Placebo Control
Cohort 4: Received one sterile saline injection (with phototherapy as needed) during participation in an earlier interventional trial (NCT00850993)
干预措施: Phototherapy (as needed) (Other)
结局指标
主要结局
Number of participants with adverse events
时间窗: within 52 months
次要结局
未报告次要终点