NL-OMON55635已完成3 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 - ARGX-113-1705 (ADAPT+)
argenx BVBA0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients will roll over in this trial only if they meet all of the following
- •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.
排除标准
- •Patients will not roll over in this trial if they meet any of the following
- •1. Patients who discontinued early from trial ARGX-113-1704 or patients who
- •discontinued early from randomized treatment for pregnancy or rescue 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 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 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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