Study Evaluating the Efficacy and Safety of Artesunate

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

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.

Study Overview

• Status: Recruiting
• Conditions: CMV Infection
• Intervention / Treatment: Drug: Artesunate; Drug: Ganciclovir (GCV)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa Read; Phone Number: 240-285-9905; Email: Lisa.Read@amivas.com

Study Locations

• Australia
  • Westmead, Australia
    • Terminated
    • Westmead Hospital
  • Woolloongabba, Australia
    • Terminated
    • Princess Alexandra Hospital
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Camille Kotton, MD
      • Contact: Jaqueline Ferreira, BS; Phone Number: 617-643-4179; Email: jrferreira@mgh.harvard.edu
      • Contact: Camille Kotton, MD; Email: ckotton@mgh.harvard.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Adam Miller; Phone Number: 507-266-8147; Email: miller.adam@mayo.edu
      • Contact: Raymund Razonable, MD; Email: razonable.raymund@mayo.edu
      • Principal Investigator: Raymund Razonable, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose Artesunate; 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; 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
Experimental: High Dose Artesunate; 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; 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
Active Comparator: Standard Treatment Ganciclovir; Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices	Drug: Ganciclovir (GCV); Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Amivas Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CMV infection
• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Terpenes; Inorganic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Reactive Oxygen Species; Free Radicals; Artemisinins; Sesquiterpenes; Acyclovir; Artesunate; Ganciclovir
• Other Study ID Numbers: IVAS-CMV-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No