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RecruitingPhase 2NCT06853184

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

Sponsor

Amivas Inc.

Enrollment

90 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

CMV Infection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria8

  • 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
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Interventions

DRUGArtesunate

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

DRUGGanciclovir (GCV)

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

Locations(2)

Westmead Hospital

Westmead, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

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NCT06853184

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