Home › Cytomegalovirus Infections › NCT06853184
Study Evaluating the Efficacy and Safety of Artesunate
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Artesunate (drug)
- Ganciclovir (GCV) (drug)
Sponsor: Amivas Inc. · Participants: 90 · Started: Aug 1, 2025
Contact the study team
- Bryan Smith · Phone: 301-807-8548
Official record on ClinicalTrials.gov — NCT06853184
Locations in the U.S.
| Massachusetts | Massachusetts General Hospital, Boston |
| Minnesota | Mayo Clinic, Rochester |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.