Solid Organ TransplantationGANEXNCT03088553
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 of Solid Organ Transplantation, run by Rennes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Transplantation
- What is being tested?
- Therapeutic Drug Monitoring
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2017to 21 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Solid organ transplanted patients with CMV reactivation or CMV disease.
Who may be able to join
- 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.
Who cannot join
- pregnancy
- opposition to participate in the study
- incapable person
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Rennes
Rennes, 35000
Clémence MD VERDIER, 299284361 ext. +33, clemence.verdier@chu-rennes.fr
About this study
Official title: Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament
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.
- Conditions
- Solid Organ Transplantation
- Being tested
- Therapeutic Drug Monitoring
- Keywords
- Ganciclovir, trough concentrations, CMV viral load, safety, Solid organ transplantation (heart, kidney or liver)
- Medical subject headings
- Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Drug MonitoringDrug
Trough concentration of ganciclovir and viral load measurement at each follow-up visit.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start21 Feb 2017
- Primary completion21 Dec 2023 (estimated)
- Study completion21 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088553
- Sponsor's protocol ID
- 35RC16_9773
- Acronym
- GANEX
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2017
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Observationnelle Comparant l'efficacité du GANciclovir en Fonction de l'EXposition Sanguine au médicament
- ClinicalTrials.gov ID
- NCT03088553
- Acronym / sponsor ID
- GANEX / 35RC16_9773
- Conditions
- Solid Organ Transplantation
- Keywords
- Ganciclovir, trough concentrations, CMV viral load, safety, Solid organ transplantation (heart, kidney or liver)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Dec 2023 (estimated)
- Study completion
- 21 Jun 2024 (estimated)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Solid organ transplanted patients with CMV reactivation or CMV disease.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- pregnancy
- opposition to participate in the study
- incapable person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Drug MonitoringTrough concentration of ganciclovir and viral load measurement at each follow-up visit. | Drug | – |
Primary outcome
Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir
Time frame: through study completion, an average of 1 year
Duration of patient follow-up for the CMV infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Organ Transplantation, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristell COAT (2 99 28 91 91 ext. +33, kristell.coat@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to CMV viral load negativity as a function of the median of trough concentrations of ganciclovir (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.