Study Evaluating the Efficacy and Safety of Artesunate

NCT06853184 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IVAS-CMV-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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

CMV Infection

Keywords

CMV infection

Outcome Measures

Primary Outcomes (1)

• Reduction of cytomegalovirus (CMV) DNAemia

  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

  28 days

Study Arms (3)

Low Dose Artesunate

EXPERIMENTAL

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

Drug: Artesunate

High Dose Artesunate

EXPERIMENTAL

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

Drug: Artesunate

Standard Treatment Ganciclovir

ACTIVE COMPARATOR

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

Drug: Ganciclovir (GCV)

Interventions

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

High Dose Artesunate; Low Dose Artesunate

Ganciclovir (GCV) DRUG

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

Standard Treatment Ganciclovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amivas Inc.: lead

Study Sites (2)

Westmead Hospital

Westmead, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Australia

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Artesunate; Ganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Lisa Read

CONTACT

240-285-9905; Lisa.Read@amivas.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)