NCT03088553

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

6.8 years

First QC Date

March 10, 2017

Last Update Submit

April 11, 2023

Conditions

Solid Organ Transplantation

Keywords

Ganciclovirtrough concentrationsCMV viral loadsafetySolid organ transplantation (heart, kidney or liver)

Outcome Measures

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

    through study completion, an average of 1 year

Interventions

Therapeutic Drug MonitoringDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Solid organ transplanted patients with CMV reactivation or CMV disease.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Central Study Contacts

Kristell COAT

CONTACT

2 99 28 91 91kristell.coat@chu-rennes.fr

Direction de la recherche

CONTACT

2 99 28 25 55DRC@chu-rennes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 23, 2017

Study Start

February 21, 2017

Primary Completion

December 21, 2023

Study Completion

June 21, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(1)