EUCTR2017-001176-31-HU进行中（未招募）1 期
BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies
Bayer AG,0 个研究点目标入组 300 人开始时间: 2017年7月7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
- 300
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
- •1.All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study. Also, those original BENEFIT subjects who prematurely discontinued study participation in any of the prior BENEFIT studies areeligible for inclusion in the BENEFIT 15 study.
- •2.Subjects with signed written informed consent
- •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 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the subject’s ability to understand the purpose of the study
- •2.Subjects who meet any of the following criteria will only be excluded from the MRI assessment. However, these subjects should be encouraged to nevertheless participate in the clinical part of the study:
- •3.Pregnant or nursing (including pumping for storage and feeding)
- •4.Contraindications to MRI examination (e.g., inability to hold breath, severearrhythmias, very low cardiac output, severe claustrophobia, or subjects with implanted defibrillators or other metallic devices not approved for MRI)
- •5.Suspected clinical instability or unpredictability of the clinical course during the study (e.g., due to previous surgery or acute stroke)
研究者
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