ClinicalTrials.gg
RecruitingNCT06853184Updated Aug 3, 2026

Study Evaluating the Efficacy and Safety of Artesunate

A Phase 2 interventional study of Artesunate and Ganciclovir (GCV) in CMV Infection, sponsored by Amivas Inc.. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Amivas Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 178 studies in Cytomegalovirus Infections with a site in United States — 15 open to participants now, 21 under way, 2 of them phase 3. Cytomegalovirus Infections · United States.

Planned enrollment
54th of 139
90 · median 61
Started
2025
with 5 others
Phase 2
36 of 178
3 open now
Primary completion
2028-05
later than 13 of 20 live
Registered
171st of 178
by date

Among the 178 studies in Cytomegalovirus Infections with a site in United States, this one is the 54th largest by planned enrollment of the 139 interventional ones that give a count, is one of 6 that started in 2025, is one of 36 in phase 2, reaches primary completion later than 13 of the 20 other live ones, and was the 171st registered.

Cytomegalovirus Infections

370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.

Browse Cytomegalovirus Infections studies →

Open to participants now

15 of the 178 studies in Cytomegalovirus Infections with a site in United States are open now. Recruiting first, the newest first:

9 more — sign in →

All 15 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 178 studies in Cytomegalovirus Infections with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • CMV Infection

Keywords

  • CMV infection
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 of ≥ 12 weeks
  • Be willing and have an understanding and ability to fully comply with the study
  • If female use

Exclusion criteria

Exclusion Criteria:

  • Have taken IV GCV or oral VGC daily for >8 days
  • Have CMV infection or disease
  • Have CMV antiviral drug resistance
  • Have a known 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 drug with anti-CMV activity
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study 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

    Drug: Artesunate

  • 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

  • Active comparator
    Standard Treatment Ganciclovir

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

    Drug: Ganciclovir (GCV)

Interventions

  • 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

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

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 of 4 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for May 2028, 33 months after the start.

Of 29 phase 2 interventional studies under Cytomegalovirus Infections, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 62. This study's planned 33 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2025
First posted
Feb 28, 2025
StartActual
Aug 1, 2025
Primary completionEst.
May 31, 2028
CompletionEst.
Jun 30, 2028
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06853184
Lead sponsor
Amivas Inc.
Responsible party
Sponsor
First posted
Feb 28, 2025
Start date
Aug 1, 2025
Primary completion
May 31, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 3, 2026

Study contacts

Bryan Smith
Contact
Bryan.Smith@amivas.com
301-807-8548

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Artesunate

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