NCT06682234撤回2 期
A Phase 2, Single-Arm Study of Obeldesivir for Postexposure Prophylaxis of Filovirus Diseases
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 400
- 主要终点
- Percentage of Participants Experiencing Serious Adverse Events (SAEs)
研究概览
简要总结
The goal of this clinical study is to learn more about the study drug, obeldesivir (ODV), and how safe and effective it is preventing Filovirus disease in participants with known or suspected exposure to Filovirus disease.
The primary objective is to evaluate the safety and tolerability of ODV for Ebola virus (EBOV), Sudan virus (SUDV), and MARV postexposure prophylaxis (PEP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Able to understand and give written informed consent and comply with treatment and follow up.
- •Individuals who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception
- •Known or suspected high-risk exposure to Ebola virus (EBOV), Sudan virus (SUDV), or Marburg virus (MARV) within 21 days of Day
- •High-risk exposure may include the following:
- •Direct contact with bodily fluids from a confirmed case.
- •Needle stick injury with a needle potentially contaminated with virus.
- •Prolonged exposure to an individual with EBOV, SUDV, or MARV infection or disease without (adequate) personal protective equipment.
排除标准
- •Individuals with plans to breastfeed during the study period and 21 days following the last dose of study intervention. World Health Organization guidance on breastfeeding should be followed.
- •Known hypersensitivity to the study intervention, its metabolites, or formulation excipient.
- •Known EBOV, SUDV, or MARV reverse transcriptase-polymerase chain reaction (RT-PCR) positivity or symptomatic filovirus disease as attributed by the investigator.
- •Known moderate or severe renal impairment or known estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m^
- •Decompensated cirrhosis (Child-Pugh Class C), acute liver injury/failure (eg, new onset [< 2 weeks] of easy bruising, jaundice, ascites, hepatic encephalopathy, asterixis), and/or known alanine aminotransferase ≥5 × upper limit of normal.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Obeldesivir (ODV)
Experimental
Participants will receive ODV for 10 days
干预措施: obeldesivir (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
时间窗: First dose date up to 29 Days
次要结局
- Proportion of Participants with Symptomatic Filovirus Disease by Day 29(Up to 29 Days)
- Proportion of Participants with All-Cause Death by Day 29(Up to 29 Days)
- Proportion of Participants with Polymerase Chain Reaction (PCR)-Confirmed Filovirus Disease Infections by Day 29(Up to 29 Days)
研究者
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