EUCTR2015-001411-12-IT进行中（未招募）1 期
Extension of the CBYM338B2203 phase IIb/III study to evaluate the longtermefficacy, safety and tolerability of intravenous BYM338 in patientswith sporadic inclusion body myositis - Extension study to evaluate the long-term efficacy, safety and tolerability
OVARTIS FARMA S.P.A.0 个研究点目标入组 240 人开始时间: 2018年2月27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
- 240
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
- •- Patients who completed the core study
- •- Written informed consent must be obtained before any extension study
- •assessment is performed
- •- Able to communicate well with the investigator
- •- Willing to participate for the entire duration of the extension study with
- •commitment to follow study requirements and procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •- Women who are pregnant
- •- Women of child-bearing potential unless they are using highly effective
- •methods of contraception during dosing and for 6 months after the last
- •BYM338 dose
- •- Current use of prohibited treatments
- •- History of severe hypersensitivity reaction in the core study
- •- History of adverse event(s) (including those from the core study) prior
- •to the start of study drug in the extension study that, in the judgment of
- •the investigator, taking into account the subject's overall status, prevent
- •the subject from entering the extension study
- •- Clinically significant abnormal liver function tests
- •- Any medical condition or laboratory finding which, in the opinion of the
- •investigator may interfere with participation in the study, might
- •confound the results of the study, or pose an additional safety risk in
- •administering BYM338
- •Other protocol-defined exclusion criteria may apply.
研究者
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