Study Evaluating the Efficacy and Safety of Artesunate

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.

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Key information

Conditions

CMV Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Westmead Hospital, Westmead, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artesunate

Drug

Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices

Ganciclovir (GCV)

Drug

Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

Primary outcomes

Reduction of cytomegalovirus (CMV) DNAemia

Time frame: 28 days

Determine if Artesunate for Injection (intravenous [IV] artesunate) when administered in combination with IV Ganciclovir (GCV) and/or oral valganciclovir (VGCV) and standard of care (SOC) treatment impacts change of cytomegalovirus (CMV) DNAemia compared with those who only received GCV or VGCV and SOC treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Read

CONTACT

[email protected]

240-285-9905

Sponsors and collaborators

Lead sponsor

Amivas Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Feb 28, 2025
Registry last updated: May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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