Actively Recruiting
Study Evaluating the Efficacy and Safety of Artesunate
Led by Amivas Inc. · Updated on 2025-10-20
90
Participants Needed
2
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Study Evaluating the Efficacy and Safety of Artesunate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 63 12 weeks
- Be willing and have an understanding and ability to fully comply with the study
- If female use birth control
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Westmead Hospital
Westmead, Australia
Actively Recruiting
2
Princess Alexandra Hospital
Woolloongabba, Australia
Actively Recruiting
Research Team
L
Lisa Read
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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