EUCTR2020-000067-23-FR进行中（未招募）1 期
First in Human Study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of PPSGG in anti-MAG neuropathy patients
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
- •Age between 18 and 80 years, male and female.
- •Patient with a confirmed diagnosis of monoclonal IgM associated with MGUS with anti-MAG activity (titer of > 10’000 BTU) and demyelinating neuropathy defined by electrophysiological criteria according to EFNS/PNS PDN guideline, 2010.
- •Clear clinical signs of disability: with at least ONLS = 2 in lower extremities.
- •Inflammatory Neuropathy Cause and Treatment (INCAT) sensory sum score =2.
- •Adequate hepatic and renal function
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Patients with total serum IgM levels >30 g.
- •Hematological malignancy, prior malignancy of any organ system (except BCC)
- •Prior immunosuppression: No IVIG in previous 3 months, no previous cyclophosphamide or biologicals in prior 6/12.
- •Other neurological, neuromuscular, rheumatologic or orthopedic condition with significant impact on the capabilities of walk preventing evaluation of neurological scores
研究者
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