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Recruiting NCT06853184

Study Evaluating the Efficacy and Safety of Artesunate

Phase II Interventional CMV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artesunate, Ganciclovir (GCV).
Who it may be relevant to
Registry conditions: CMV Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • 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
  • Drug Ganciclovir (GCV)
    Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

Primary outcome measures

  • Reduction of cytomegalovirus (CMV) DNAemia [Time frame: 28 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Massachusetts General Hospital — Boston
  • Mayo Clinic — Rochester
Australia · 2 centers
  • Westmead Hospital — Westmead
  • Princess Alexandra Hospital — Woolloongabba

Identifiers

NCT: NCT06853184 · IVAS-CMV-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗