Study Evaluating the Efficacy and Safety of Artesunate
Recruiting now · Phase 2
Conditions studied: CMV Infection
In brief
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.
Key facts
- Study ID
- NCT06853184
- Run by
- Amivas Inc.
- People needed
- 90
- Starts
- 2025-08-01
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Mayo Clinic — Rochester, Minnesota, United States (enrolling)
- Westmead Hospital — Westmead, Australia
- Princess Alexandra Hospital — Woolloongabba, Australia
Full record on ClinicalTrials.gov
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