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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Artesunate
Drug
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)
Drug
Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Low Dose ArtesunateExperimental treatment 1 intervention

Group B: High Dose ArtesunateExperimental treatment 1 intervention

Group C: Standard Treatment GanciclovirActive comparator 1 intervention

Trial outcomes

Primary outcomes

Reduction of cytomegalovirus (CMV) DNAemia

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

Time frame

28 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amivas Inc.

Lead sponsor

Source ClinicalTrials.gov

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