NL-OMON52460
招募中
2 期
Open-label Extension of the ARGX-113-1802 Trial to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - ADHERE+
Argenx BVBA0 个研究点目标入组 4 人待定
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- damaged myelin sheath of nerve fibers
- 发起方
- Argenx BVBA
- 入组人数
- 4
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Ability to understand the requirements of the trial, provide written
- •informed consent (including consent for the use and disclosure of
- •research\-related health information), willingness and ability to comply with
- •the trial protocol procedures (including required trial visits) of this trial.
- •2\.a. Male or female patient with one of the following options:
- •\- Have completed the Week\-48 visit of Stage B of the ARGX\-113\-1802 trial and
- •are considered to be eligible for treatment with efgartigimod PH20 SC; or
- •\- Have deteriorated during Stage B of the ARGX\-113\-1802 trial and are
- •considered to be eligible for treatment with efgartigimod PH20 SC, or
- •\- Have been offered the participation in the OLE trial due to early termination
排除标准
- •1\. Week\-48/ED visit in the ARGX\-113\-1802 trial or the Week\-48 visit of the
- •previous OLE participation occurred more than 14 days prior to SD1 of the OLE
- •trial or the start of a new treatment cycle in the OLE trial and more than 21
- •days since the last dose of IMP.
- •2\. Pregnant and lactating women and those intending to become pregnant during
- •3\. a. Patients with clinical evidence of other significant serious disease or
- •patients who underwent a recent or have a planned major surgery, or patients
- •who (intend to) use prohibited medications and therapies during the trial, or
- •any other reason which could confound the results of the trial or put the
- •patient at undue risk.
结局指标
主要结局
未指定
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