Study Evaluating the Efficacy and Safety of Artesunate

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Reduction of cytomegalovirus (CMV) DNAemia — 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

Trial sites (4)

More Amivas Inc. trials in the USA