Study Evaluating the Efficacy and Safety of Artesunate

Amivas Inc.

Status and phase: Enrolling; Phase 2

Conditions: CMV Infection

Treatments: Drug: Ganciclovir (GCV); Drug: Artesunate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06853184

IVAS-CMV-01

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Low Dose Artesunate

Experimental group

Description:

Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices

Treatment:

Drug: Artesunate

High Dose Artesunate

Experimental group

Description:

High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices

Treatment:

Drug: Artesunate

Standard Treatment Ganciclovir

Active Comparator group

Description:

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

Treatment:

Drug: Ganciclovir (GCV)