Study Evaluating the Efficacy and Safety of Artesunate
Amivas Inc. · NCT06853184
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 90
- US sites recruiting
- 2
- Study start
- August 1, 2025
- Record last updated
- August 3, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Artesunate; Ganciclovir (GCV)
Conditions: CMV Infection
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Massachusetts General Hospital
Boston, MA 02114
Site contact: Jaqueline Ferreira, BS · 617-643-4179 · jrferreira@mgh.harvard.edu
Mayo Clinic
Rochester, MN 55905
Site contact: Adam Miller · 507-266-8147 · miller.adam@mayo.edu
Study contacts (from the official record)
- Bryan Smith · 301-807-8548 · Bryan.Smith@amivas.com