Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000645752
Ethics application status
Approved
Date submitted
13/01/2022
Date registered
3/05/2022
Date last updated
5/04/2023
Date data sharing statement initially provided
3/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modeling of pharmacokinetics of ganciclovir
Scientific title
Pharmacokinetics of ganciclovir by lung transplantation patients
Secondary ID [1] 306199 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cytomegalovirus infection 324904 0
Condition category
Condition code
Infection 322343 322343 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Lung transplant patients receiving intravenous ganciclovir (5 mg/kg) twice daily for at least 48 hours after transplantation, blood samples will be collected and ganciclovir levels in the blood will be measured,
The duration and frequency of observation in participants, 3-times for the first 24 hours and then in the sixth month post lung-transplant
Intervention code [1] 322602 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330104 0
estimating ganciclovir AUC in lung transplant patients using NONMEN
Pharmacokinetics of ganciclovir assessed using blood samples. The pharmacokinetic parameter of interest is AUC
valganciclovir is prodrug of ganciclovir
Timepoint [1] 330104 0

5 minutes prior dosing and 2,4,6 hours post dose
Secondary outcome [1] 404903 0
pharmacokinetics parameter - serum assay
the parameters to be examined, . ganciclovir Cmax, ganciclovir Tmax, ganciclovir T1/2, AUC
pharmacokinetics of ganciclovir in blood sample
Timepoint [1] 404903 0

5 minutes prior to dosing and 2,4,6 hours post dose

Eligibility
Key inclusion criteria
had undergone lung transplantation and treated with intravenous ganciclovir twice daily for at least 48 hours after transplantation
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
incomplete date

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 24493 0
Czech Republic
State/province [1] 24493 0
Prague

Funding & Sponsors
Funding source category [1] 310545 0
Hospital
Name [1] 310545 0
Motol University Hospital
Country [1] 310545 0
Czech Republic
Primary sponsor type
Hospital
Name
Motol University Hospital
Address
V Úvalu 84/1
150 06 Prague 5
Country
Czech Republic
Secondary sponsor category [1] 311715 0
University
Name [1] 311715 0
Charles university
Address [1] 311715 0
Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country [1] 311715 0
Czech Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310159 0
Motol ethics committee
Ethics committee address [1] 310159 0
V Úvalu 84/1
150 06 Praha 5
Ethics committee country [1] 310159 0
Czech Republic
Date submitted for ethics approval [1] 310159 0
Approval date [1] 310159 0
01/12/2020
Ethics approval number [1] 310159 0

Summary
Brief summary
The aim of this prospective study was to evaluate the pharmacokinetics of ganciclovir in lung transplant recipients and to explore its covariates and propose an individualized ganciclovir dosing regimen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116694 0
Mrs eliška dvorácková
Address 116694 0
Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country 116694 0
Czech Republic
Phone 116694 0
+420 721 132 330
Fax 116694 0
Email 116694 0
eliskadvorackova@seznam.cz
Contact person for public queries
Name 116695 0
Mrs eliška dvorácková
Address 116695 0
Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country 116695 0
Czech Republic
Phone 116695 0
+420 721 132 330
Fax 116695 0
Email 116695 0
eliskadvorackova@seznam.cz
Contact person for scientific queries
Name 116696 0
Mrs eliška dvorácková
Address 116696 0
Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic
Country 116696 0
Czech Republic
Phone 116696 0
+420 721 132 330
Fax 116696 0
Email 116696 0
eliskadvorackova@seznam.cz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
intelectual property


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.