NL-OMON53633招募中2 期
A Long-Term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerabillity, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy - ARDA+
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- argenx BV
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants are eligible to be included in the trial only if all of the
- •following criteria apply:
- •1. Capable of providing signed informed consent, and complying with protocol
- •requirements. Participants must be able to read and write.
- •2. Must have completed the double-blinded treatment period of the ARGX-117-2002
- •trial and considered to be eligible for treatment with ARGX-117
- •3. Agrees to use contraceptive measures consistent with local regulations and
- •the following:
- •a. Male participants: must use an acceptable contraceptive method that should
- •be maintained at minimum until 15 months after last dose of Investigational
- •Medicinal Product (IMP).
- •b. Female participants (women) of childbearing potential must have a negative
- •urine pregnancy test at baseline before IMP can be administered.
排除标准
- •Participants will be excluded from the trial if any of the following criteria
- •1. Clinically significant uncontrolled active or chronic bacterial, viral, or
- •fungal infection
- •2. Clinical evidence of other significant serious diseases, have had a recent
- •major surgery, or who have any other condition, in the opinion of the
- •investigator, that could confound the results of the trial or put the
- •participant at undue risk.
- •3. Currently participating in another interventional clinical study
- •4. Pregnant or lactating or intend to become pregnant during the trial or
- •within 15 months after last dose of the IMP.
研究者
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