Study Evaluating the Efficacy and Safety of Artesunate
Key facts
- Where
- Boston and Rochester, United StatesSee the 2 sites
- Phase
- Phase 2
Where in United States
- Massachusetts General HospitalBoston, United StatesContact: Jaqueline Ferreira, BSTaking people
- Mayo ClinicRochester, United StatesContact: Adam MillerTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Amivas Inc.
- Trial code
- NCT06853184
- Record updated
- 3 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Have CMV antiviral drug resistance; 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; Have refractory CMV infection or disease; Have a known hypersensitivity to artesunate, GCV, or VGCV; Have severe liver disease; Have taken IV GCV or oral VGC daily for >8 days; Pregnant (or expecting to conceive) or nursing.