Study Evaluating the Efficacy and Safety of Artesunate

Launched by AMIVAS INC. · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called artesunate to see how effective and safe it is for treating a viral infection known as cytomegalovirus (CMV) in patients who have received solid organ transplants, like kidneys, lungs, hearts, or livers. Participants will receive artesunate along with other standard treatments, and their results will be compared to those who only get the standard treatments. The goal is to find out if adding artesunate improves the treatment outcomes for these patients.

To be eligible for this study, participants must be at least 18 years old, have a confirmed CMV infection, and have received a solid organ transplant. They should also be able to follow the study requirements and have a life expectancy of at least 12 weeks. Participants will need to stop taking certain antiviral medications before joining the trial and must not have any serious health issues that could interfere with the study. If someone chooses to participate, they will be closely monitored throughout the trial to ensure their safety and to collect data on how well the treatment works. This trial is not yet recruiting participants, so there will be more information available as it progresses.

Gender

ALL

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