NCT06853184PHASE2Recruiting
Study Evaluating the Efficacy and Safety of Artesunate
Amivas Inc.
Start Date
8/1/2025
Completion Date
6/30/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
DRUG
Artesunate
DRUG
Ganciclovir (GCV)
Conditions
CMV Infection
Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Westmead Hospital
Westmead,
Australia
Princess Alexandra Hospital
Woolloongabba,
Australia