A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicentric Study of Dengue Monoclonal Antibody in Children more than or equal to 5 Years and Adults with Dengue
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 15
- 主要终点
- Viral Log Reduction [VLR] (overall) of infective dengue virus measured by NS1 ELISA based TCID50 test (NSET)
研究概览
简要总结
This is a Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicentric Study of Dengue Monoclonal Antibody in Children more than or equal to 5 Years and Adults with Dengue. The Participant to be with fever onset within last 48 hours and positive for NS1 test. The participants will be administered either with Dengue-mAb or Placebo as per the randomization scheme in 1:1 proportion. Total 500 participants will be randomized on the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The study participants will be Children 5 years and adults.
- •Participants or parents who give written informed consent.
- •History of fever within 48 hours from onset.
- •Participants who are willing to be hospitalized post infusion for a period of at least 72 hours of afebrile period.
排除标准
- •Patient meets criteria for Severe Dengue
- •History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, neuropsychiatric, autoimmune, dermatologic or immunosuppressive disorders.
- •History of allergic disease, allergic reactions or known hypersensitivity to any component of the study product (Mild non-medication allergies allowed).
结局指标
主要结局
Viral Log Reduction [VLR] (overall) of infective dengue virus measured by NS1 ELISA based TCID50 test (NSET)
时间窗: at 8 hours after IP administration | AND/OR | •apyrexia for 72 hours after IP administration
AND/OR
时间窗: at 8 hours after IP administration | AND/OR | •apyrexia for 72 hours after IP administration
Time to clearance of fever
时间窗: at 8 hours after IP administration | AND/OR | •apyrexia for 72 hours after IP administration
次要结局
- VLR of infective dengue virus measured by NSET (by serotype & baseline serostatus)(8 hours after IP administration)
- VLR of infective dengue virus measured by NSET (overall, by serotype & baseline serostatus)(at 24, 48 & 72 hours after IP administration)
- VLR of dengue viral load measured by qRT-PCR (overall, by serotype & baseline serostatus)(at 24 & 48 hours after IP administration)
- Trend of platelet count, leukocyte count & hematocrit(Day1 to day 8)