Phase 2, Stratified, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MGAWN1 in Subjects With Laboratory-documented West Nile Fever or Suspected Central Nervous System Infection Due to West Nile Virus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- MacroGenics
- 入组人数
- 13
- 主要终点
- The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
研究概览
简要总结
This study will test a drug called MGAWN1 for the treatment of West Nile infections.
详细描述
The objective of this study is to evaluate the safety, efficacy, and pharmacokinetics of MGAWN1 in subjects with West Nile Fever or a syndrome compatible with West Nile Neuroinvasive Disease (WNND) [encephalitis, meningitis, or acute flaccid paralysis]. Subjects can be enrolled based on a syndrome compatible with WNND, and do not need documented West Nile virus infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Be >=18 years of age at the time of enrollment
- •Have West Nile Fever defined as:
- •temperature >38°C, headache, AND
- •positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF)
- •OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as:
- •West Nile encephalitis (must meet criteria a and b below)
- •Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours)
- •CSF pleocytosis >=5 cells/mm^3
- •West Nile meningitis (must meet criteria c and d)
- •Clinical signs of meningeal inflammation, including nuchal rigidity, Kernig or Brudzinski sign, photophobia, or phonophobia
- •CSF pleocytosis >=5 cells/mm^3
- •Acute flaccid paralysis (must meet criteria e and f)
- •Acute onset of limb weakness with marked progression over 48 hours
- •Two or more of the following conditions:
- •asymmetry to weakness
- •areflexia or hyporeflexia of affected limb(s)
- •absence of pain, paresthesia, or numbness in affected limb(s)
- •CSF pleocytosis >=5 cells/mm^3
- •CSF elevated protein levels (4.5 g/L)
- •electrodiagnostic studies consistent with an anterior horn cell process
- •or abnormal increased signal in the anterior gray matter as documented by spinal cord magnetic resonance imaging
- •Have epidemiological factors consistent with West Nile Virus infection (must meet criterion a or b below):
- •Appropriate time of year for West Nile Virus transmission in region
- •Travel history to a region where West Nile Virus is active
- •Develop signs and/or symptoms within 14 days before study enrollment.
- •If female of childbearing potential or male and in a sexual relationship with a female of childbearing potential, agree (or have partner agree) to practice abstinence or use 2 of the following methods of contraception for 120 days (approximately 4 months) after study drug administration:
- •Oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches
- •An intrauterine device
- •Barrier contraception (condom) with a spermicide (i.e., female subject ensures use by male partner[s])
- •Any other equivalent method of contraception (as judged by the investigator)
排除标准
- 未提供
结局指标
主要结局
The Number of West Nile Neuroinvasive Disease (WNND) Participants Who Show Improvement in the Modified Rankin Scale (MRS) (>=1 Improvement in Score)
时间窗: Study Day 2, 7, 14, 28, and 120
The MRS is a 7-point disability scale that assesses the degree of disability in subjects with neurological impairment. Possible scores range from 0 (perfect health) up to 5 (severe disability). The scale is as follows: * 0 = No symptoms at all * 1 = No significant disability despite symptoms; * 2 = Slight disability; * 3 = Moderate disability; * 4 = Moderately severe disability; * 5 = Severe disability; bedridden, incontinent and requiring constant nursing care and attention; * 6 = Dead
The Number of Participants Who Had At Least 1 Treatment-Related Adverse Event
时间窗: 120 days
Includes adverse events considered possibly, probably, or definitely related to study drug
次要结局
- The Number of Participants With a Favorable Neurologic Outcome(Study Day 2, 7, 14, 28, and 120)
- Mean Modified Rankin Scale Scores(Study Day 0, 2, 7, 14, 28, and 120)
- Time to a >= 1 Point Reduction in the Modified Rankin Scale Score(Study Day 2, 7, 14, 28, and 120)