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

Solid Organ Transplantation Clinical Trial

— GANEX  

Official title:

Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03088553
• Other study ID #: 35RC16_9773
• Status: Recruiting
• Start date: February 21, 2017
• Est. completion date: June 21, 2024

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: Kristell COAT
• Phone: 2 99 28 91 91
• Email: kristell.coat[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: June 21, 2024
• Est. primary completion date: December 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• pregnancy

• opposition to participate in the study

• incapable person

Related Conditions & MeSH terms

• Solid Organ Transplantation

Intervention

Drug:
• Therapeutic Drug Monitoring
Trough concentration of ganciclovir and viral load measurement at each follow-up visit.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year