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Study Evaluating the Efficacy and Safety of Artesunate
Sponsor: Amivas Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-08-01
Completion Date
2028-06-30
Last Updated
2025-10-20
Healthy Volunteers
No
Conditions
Interventions
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
Ganciclovir (GCV)
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
Locations (2)
Westmead Hospital
Westmead, Australia
Princess Alexandra Hospital
Woolloongabba, Australia