Study Evaluating the Efficacy and Safety of Artesunate

Purpose

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.

Condition

  • CMV Infection

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 - 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Low Dose Artesunate 		Low Dose Artesunate: 2.4 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
  • Drug: 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: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Experimental
High Dose Artesunate 		High Dose Artesunate: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
  • Drug: 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: 4.8 mg/kg IV artesunate once daily for 14 days + GCV or VGCV and SOC per local institutional practices
Active Comparator
Standard Treatment Ganciclovir 		Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices
  • Drug: Ganciclovir (GCV)
    Standard Treatment Ganciclovir: GCV or VGCV and SOC per local institutional practices

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Jaqueline Ferreira, BS
617-643-4179
jrferreira@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Amivas Inc.

Study Contact

Lisa Read
240-285-9905
Lisa.Read@amivas.com