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Status unknownNCT03088553GANEXUpdated Apr 12, 2023

Observational Study Comparing the Efficacy of Ganciclovir as a Function of Blood Exposure to the Drug During a Curative or Preemptive Treatment

An observational study in Solid Organ Transplantation, sponsored by Rennes University Hospital. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Rennes University Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
138
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to better define the target range of ganciclovir trough concentrations by investigating the relationship between ganciclovir concentration and the time to undetectable CMV-DNA load, in preemptive and curative treatments by (val)ganciclovir.

Read the detailed description

The primary objective of the study is to determine whether higher concentrations of ganciclovir can reduce the time of negation of the CMV-DNA load.

Secondary objectives are to determine the concentration-toxicity relationship of ganciclovir and the relationship between concentrations of ganciclovir and apparition of CMV gene mutations responsible of drug resistance.

Each week, trough concentrations of ganciclovir are measured, associated with control of CMV-DNA load and all biological analysis currently necessary for the monitoring of the infection.

02

Conditions studied

  • Solid Organ Transplantation

Keywords

  • Ganciclovir
  • trough concentrations
  • CMV viral load
  • safety
  • Solid organ transplantation (heart, kidney or liver)
03

In context

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Browse Rennes University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Solid organ transplanted patients with CMV reactivation or CMV disease.

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

  • more than 18 years-old
  • Solid organ transplanted patients needing a treatment by oral or intravenous (val)ganciclovir
  • Non-opposition to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • opposition to participate in the study
  • incapable person
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
138 participants (estimated)
Patient registry
No

Interventions

  • DrugTherapeutic Drug Monitoring

    Trough concentration of ganciclovir and viral load measurement at each follow-up visit.

06

What researchers measure

Primary outcomes

  1. Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir

    Duration of patient follow-up for the CMV infection

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Universitaire de Rennes
    Rennes, 35000, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2017 (actual). Primary completion is estimated for Dec 2023, 82 months after the start.

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

Registered
Mar 10, 2017
First posted
Mar 23, 2017
StartActual
Feb 21, 2017
Primary completionEst.
Dec 21, 2023
CompletionEst.
Jun 21, 2024
Last update
Apr 12, 2023
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 Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03088553
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Mar 23, 2017
Start date
Feb 21, 2017
Primary completion
Dec 21, 2023 (estimated)
Completion
Jun 21, 2024 (estimated)
Last update
Apr 12, 2023

Study contacts

Kristell COAT
Contact
kristell.coat@chu-rennes.fr
2 99 28 91 91 ext. +33
Direction de la recherche
Contact
DRC@chu-rennes.fr
2 99 28 25 55 ext. +33

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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