EUCTR2018-002132-25-CZ进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness
argenx BVBA0 个研究点目标入组 150 人开始时间: 2018年11月1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
- 150
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
- •1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- •2. Male or female patients aged = 18 years.
- •3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa and IVb.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
- •2. 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.
- •3. MGFA Class I and V patients
- •4. Patients with worsening muscle weakness secondary to concurrent infections or medications.
- •5.Patients with known seropositivity or who test positive for an active viral infection at Screening with: o Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination) o Hepatitis C Virus (HCV) o Human Immunodeficiency Virus (HIV)
- •Other more specific exclusion criteria are further defined in the protocol.
研究者
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