Study Evaluating the Efficacy and Safety of Artesunate

July 31, 2026 updated by: Amivas Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Westmead, Australia
        • Terminated
        • Westmead Hospital
      • Woolloongabba, Australia
        • Terminated
        • Princess Alexandra Hospital
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amivas Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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