NCT04175522已完成2 期
A Phase 2a, Prospective, Open-label, Single-arm, Single Center, Proof of Concept Study to Evaluate the Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged more than 12 years.(adolescent or adult)
- •Subject who all three of the following diagnosis criteria for possible autoimmune encephalitis have been met.
- •Subacute onset (rapid progression of less than 3 months) of working memory deficits(short-term memory loss), altered mental status, or psychiatric symptoms.
- •At least one of the following:
- •New focal CNS findings
- •Seizure not explained by a previously known seizure disorder
- •CSF pleocytosis (WBC count ≥ 5/mm2)
- •MRI features suggestive of encephalitis
- •Reasonable exclusion of alternative causes
- •Subjects or parent/legal representative willing to provide written informed consent
排除标准
- •Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
- •Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
- •Subject who has been diagnosed with IgA deficiency
- •Subject who has renal disorder (creatinine clearance < 10 ml/min) or requires dialysis
- •Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
- •Subject who has been diagnosed with immuonological competence or immunodeficiency
- •Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
- •Subject who has low heart condition (Congestive heart failure >NYHA functional class Ⅱ: unstable coronary artery disease or myocardiac infarction within 3 months prior to screening)
- •Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
- •Females who are pregnant or breast feeding
- •Subject who is considered by investigator to ineligible for the study.
研究组 & 干预措施
Experimental
Experimental
Investigational product(IP)
干预措施: Immunoglobulin G (Drug)
结局指标
主要结局
Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)
时间窗: 28 days
Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration)
次要结局
- Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)(28 days)
- Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)(28 days)
- Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)(28 days)
- Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)(28 days)
- The relationship(28 days)
- Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)(28 days)
研究者
研究点 (1)
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