Health Trials

Study Evaluating the Efficacy and Safety of Artesunate

ConditionCMV Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmivas Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Artesunate
  • Ganciclovir (GCV)

Treatment groups

90 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Amivas Inc.

Lead sponsor

Source ClinicalTrials.gov