NCT06853184

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Amivas Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-05-31
• Completion: 2028-06-30
• First posted: 2025-02-28
• Last updated: 2025-10-20

Locations

2 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study