Study Evaluating the Efficacy and Safety of Artesunate

Phase 2

Not yet recruiting

• Conditions: CMV Infection
• Interventions: Drug: Artesunate; Drug: Ganciclovir (GCV)

• Registration Number: NCT06853184
• Lead Sponsor: Amivas Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Study Start: 2025-05-01
• Primary Completion: 2028-05-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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
• Have CMV antiviral drug resistance
• Have a known hypersensitivity to artesunate, GCV, or VGCV
• Pregnant (or expecting to conceive) or nursing
• Have severe liver disease
• Require ongoing treatment with or an anticipated need for treatment with drugs with known interactions with artesunate or GCV
• Taking any another investigational drug with anti-CMV activity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Artesunate	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	Artesunate	High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Standard Treatment Ganciclovir	Ganciclovir (GCV)	Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

Primary Outcome Measures

Name	Time	Method
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 reduction of cytomegalovirus (CMV) DNAemia compared with those who only received GCV or VGCV and SOC treatment