Study Evaluating the Efficacy and Safety of Artesunate

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Amivas Inc.
Study ID
NCT06853184
Phase
PHASE2
Status
Recruiting
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Conditions

  • CMV Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Reduction of cytomegalovirus (CMV) DNAemia [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Jaqueline Ferreira, BS
[email protected]
617-643-4179
Camille Kotton, MD
[email protected]
Camille Kotton, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Adam Miller
[email protected]
507-266-8147
Raymund Razonable, MD
[email protected]
Raymund Razonable, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MAMayo Clinic· Rochester, MN

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