EUCTR2018-002133-37-IT进行中（未招募）1 期
A Long-Term, Single-Arm, Open-Label, Multicenter, Phase 3 Follow-on Trial of ARGX-113-1704 to Evaluate the Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis having Generalized Muscle Weakness - NA
ARGEN-X BVBA0 个研究点目标入组 145 人开始时间: 2021年1月22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
- 145
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 will roll over in this trial only if they meet all of the following criteria:
- •1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and can comply with the trial protocol procedures.
- •2. Patients who participated in trial ARGX-113-1704 and are eligible for roll over, as specified in the protocol.
- •Other more specific inclusion criteria are further defined in the protocol.
- •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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients will not roll over in this trial if they meet any of the following criteria:
- •1. Patients who discontinued early from trial ARGX-113-1704 or patients who discontinued early from randomized treatment for rescue or pregnancy reasons or an (S)AE that might jeopardize the safety of the patient in that trial.
- •2. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. Women of childbearing potential (DEFINITION OF TERMS) should have a negative urine pregnancy test at SEB.
- •3. Male patients who are sexually active and do not intend to use effective methods of contraception (as mentioned above) during the trial or within 90 days after the last dosing or male patients who plan
- •to donate sperm during the trial or within 90 days after the last dosing.
- •4. Patients with known hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) seropositivity.
- •Other more specific exclusion criteria are further defined in the protocol.
研究者
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