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临床试验/NCT02886598
NCT02886598已完成不适用

Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Firmagon® (Degarelix) for Injection

Ferring Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
368
试验地点
1
主要终点
Incidence of adverse events

研究概览

简要总结

The purpose of this study is to assess the safety and efficacy of Firmagon® (degarelix) for injection under the conditions of general clinical practice in Korea.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • Patients who are eligible for the treatment of Firmagon® (degarelix) for injection according to the approved product label, and Firmagon® (degarelix) treatment decided before study enrolment. Moreover, patient should have not previously received Firmagon® (degarelix) for injection before the study commencement date at each site. - Indication: treatment of advanced, hormone-dependent prostate cancer.

排除标准

  • Patients with previous or concurrent known hypersensitivity to any component of the drug.

研究组 & 干预措施

Firmagon®

Treatment according to standard clinical practice.

干预措施: degarelix (Drug)

结局指标

主要结局

Incidence of adverse events

时间窗: Up to 12 months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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