A Four-Year Blinded Outcomes Follow-up Study of Patients Who Received Stannsoporfin or Placebo in Clinical Trial 64,185-204
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 主要终点
- Reported adverse events (AEs)
研究概览
简要总结
The objectives of this follow up study are to evaluate the long-term effects of stannsoporfin (Stanate) on the health, growth, and development of patients who received a single dose of stannsoporfin with PT used to treat hyperbilirubinemia compared with patients in the control (placebo plus PT) group in clinical trial 64,185-204.
详细描述
Outcomes will be based on the following variables:
Reported AEs and SAEs Hearing assessments Developmental assessments
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 52 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received IMP (stannsoporfin or placebo) in clinical trial 64,185-204
- •Parents or guardians have given written informed consent to participate
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants received placebo during the earlier study
干预措施: Placebo (Drug)
Stannsoporfin 3.0 mg/kg
Participants received Stannsoporfin 3.0 mg/kg during the earlier study
干预措施: Stannsoporfin (Drug)
Stannsoporfin 4.5 mg/kg
Participants received Stannsoporfin 4.5 mg/kg during the earlier study
干预措施: Stannsoporfin (Drug)
结局指标
主要结局
Reported adverse events (AEs)
时间窗: 48-52 month
次要结局
- Developmental assessments(48 - 52 month)
- Hearing assessments(48 - 52 month)