EUCTR2014-004239-37-SE进行中（未招募）1 期
ong-term safety, curvature deformity characterization, and immunogenicity over time in subjects previously treated with AA4500 for Peyronie’s disease in studies AUX-CC-802, AUX-CC-803, AUX CC 804, and AUX-CC-806 - Long-term safety study in men previously treated with AA4500 for Peyronie's Disease
Auxilium UK Limited0 个研究点目标入组 750 人开始时间: 2014年11月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •To be eligible for this study a subject had to:
- •1. Have received at least one injection of AA4500 and completed at least the first or last follow-up visit in one of the Auxilium-sponsored studies (AUX-CC-802, AUX-CC-803, AUX-CC-804, orAUX-CC-806).
- •2. Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator.
- •3. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board / Independent Ethics Committee (IRB / IEC).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 638
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- 未提供
研究者
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