Celgosivir Proof of Concept Trial for Treatment of Acute Dengue Fever
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Virological Log Reduction (Virological Endpoint)
研究概览
简要总结
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study to Evaluate the Activity, Pharmacokinetics, Safety and Tolerability of Celgosivir in Adults with Confirmed Dengue Fever.
详细描述
Patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the Investigational Medicine Unit. Patients will be randomized 1:1 to celgosivir or placebo. Capsules of placebo or celgosivir will be administered for 5 days. While in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative NS1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (PK). Safety assessments will be conducted. At discharge on Study Day 5, patients will be asked to return on Study Days 7, 10, and 15 for blood sampling and safety assessments.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fever of ≥ 38°C of ≤ 48 hr duration.
- •At least two of the following criteria indicating probable dengue infection:
- •Live or work in or recent travel to dengue endemic area
- •Nausea and vomiting
- •Presence of rash
- •Aches and pains, including headache, or retro-orbital, muscle or joint pain
- •Positive NS1 strip assay
排除标准
- •Clinical signs and symptoms for severe dengue
- •Patients with certain abnormal laboratory values
- •History of presently active intestinal disorders
- •Severe diarrhea
- •Current usage of anticoagulant drugs
- •Other clinically significant acute illness
- •History of severe drug and/or food allergies
- •Exposure to investigational agent within 30 days prior to study drug administration
- •Clinically significant abnormal physical exam unrelated to dengue fever
- •Pregnancy
研究组 & 干预措施
Celgosivir
干预措施: celgosivir (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Virological Log Reduction (Virological Endpoint)
时间窗: 4 days
Fever Reduction (Clinical Endpoint)
时间窗: 4 days
次要结局
- Safety-Proportion of patients experiencing adverse events and serious adverse events(14 days)
- Quantitative NS1 and NS1 clearance(14 days)
- Pharmacokinetics - Clearance of drug (L/hr)(5 days)
- Hematology(14 days)