EUCTR2013-000949-39-BE进行中(未招募)1 期
An Observational Study Providing 12 Months of Safety Follow-Up from First Exposure to HP802-247 in Subjects Who Participated in Study 802-247-09-032(EU)
Smith & Nephew Inc.0 个研究点目标入组 440 人开始时间: 2013年9月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 440
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
- All
入选标准
- •- The informed consent document must be read, signed, and dated by the subject or the subject’s legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject’s chart.
- •- Subject was randomized in 802-247-09-032 and received at least one application of test article.
- •- Subject has ended their participation in 802-247-09-032 by virtue of completing the study, or by dropping out prior to completion.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 264
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •Subjects who refuse to provide written informed consent for this study will be excluded from this study.
研究者
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