Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amivas Inc.
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Reduction of cytomegalovirus (CMV) DNAemia
研究概览
简要总结
This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy and SOC treatment in SOT recipients with clinically significant CMV 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
- 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
- •Be at least 18 years of age
- •Recipient of a solid organ transplant (kidney, lung, heart, or liver)
- •Have a documented CMV infection
- •Have CMV DNAemia
- •Require IV GCV or oral VGCV
- •Be washed out from any anti-CMV antiviral drugs
- •Have all the following results as part of screening laboratory assessments
- •Have life expectancy of ≥ 12 weeks
- •Be willing and have an understanding and ability to fully comply with the study
- •If female use birth control
排除标准
- •Have taken IV GCV or oral VGC daily for >8 days
- •Have refractory CMV infection or disease
- •Have CMV antiviral drug resistance
- •Have a known hypersensitivity to artesunate, GCV, or VGCV
- •Pregnant (or expecting to conceive) or nursing
- •Have severe liver disease
- •Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV
- •Taking any another investigational drug with anti-CMV activity
研究组 & 干预措施
Low Dose Artesunate
Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
干预措施: Artesunate (Drug)
High Dose Artesunate
High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
干预措施: Artesunate (Drug)
Standard Treatment Ganciclovir
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
干预措施: Ganciclovir (GCV) (Drug)
结局指标
主要结局
Reduction of cytomegalovirus (CMV) DNAemia
时间窗: 28 days
Determine if Artesunate for Injection (intravenous \[IV\] artesunate) when administered in combination with IV Ganciclovir (GCV) and/or oral valganciclovir (VGCV) and standard of care (SOC) treatment impacts change of cytomegalovirus (CMV) DNAemia compared with those who only received GCV or VGCV and SOC treatment
Reduction of cytomegalovirus (CMV) DNAemia
时间窗: 28 days
Determine if Artesunate for Injection (intravenous \[IV\] artesunate) when administered in combination with IV Ganciclovir (GCV) and/or oral valganciclovir (VGCV) and standard of care (SOC) treatment impacts change of cytomegalovirus (CMV) DNAemia compared with those who only received GCV or VGCV and SOC treatment
次要结局
未报告次要终点