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
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 *…
Interventions
- DrugArtesunate