Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,905
- 试验地点
- 2
- 主要终点
- Percentage of Participants who had One or More Serious Adverse Events
研究概览
简要总结
The purpose of this survey is to evaluate the long-term safety and efficacy of leuprorelin acetate injection kit 11.25 mg in patients with spinal and bulbar muscular atrophy (SBMA) in the routine clinical setting.
详细描述
The drug being tested in this survey is called leuprorelin acetate injection kit 11.25 mg. This injection kit is being tested to treat people who have SBMA.
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the leuprorelin acetate injection kit 11.25 mg in the routine clinical setting. The planned number of observed patients will be approximately 300.
This multi-center observational trial will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All SBMA patients who have been confirmed as receiving the drug
排除标准
- 未提供
研究组 & 干预措施
Leuprorelin Acetate 11.25 mg
Leuprorelin Acetate Injection Kit 11.25 mg, every 12 weeks subcutaneously, for up to at most 8 years. Participants received interventions as part of routine medical care.
干预措施: Leuprorelin Acetate (Drug)
结局指标
主要结局
Percentage of Participants who had One or More Serious Adverse Events
时间窗: Up to 1 Year
Percentage of participants who have the serious adverse events that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported.
Percentage of Participants who had One or More Adverse Drug Reactions
时间窗: Up to 1 Year
Adverse drug reaction refers to adverse events related to administered drug. Percentage of participants who have the adverse drug reactions that occurred between initiation of treatment with the drug and 1 year after the start of treatment with the drug (or 3 months after the last dose of the drug if the treatment was discontinued within the first four doses) will be reported.
次要结局
- Percentage of Participants without Death Event(At final assessment point (up to 8 years))
- Percentage of Participants without Pneumonia Requiring Hospitalization Event(At final assessment point (up to 8 years))
- Percentage of Participants without Dysphagia Events(At final assessment point (up to 8 years))
- Percentage of Participants without Composite Events of Death and Pneumonia Requiring Hospitalization(At final assessment point (up to 8 years))