(Val)Ganciclovir TDM in Transplant Recipients
(Val)Ganciclovir Therapeutic Drug Monitoring in Transplant Recipients
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of this study is to gain more insight into therapeutic drug monitoring and thus the pharmacodynamics and pharmacokinetics of ganciclovir, in the context of prophylaxis and treatment of CMV infections, in order to provide the patient with an adequate dose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2018
CompletedStudy Start
First participant enrolled
May 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedOctober 10, 2019
October 1, 2019
1.5 years
February 7, 2018
October 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure of CMV treatment (with valganciclovir and ganciclovir) using viral load measurements and determining mutations in CMV kinase gene UL97 and DNA polymerase gene UL54
How many days to the development of failure of treatment? Failure of treatment is defined by increased viral load (measured in serum, whole blood, plasma in copies per mL and/or viral resistance (change of ganciclovir treatment to foscarnet treatment as a consequence, resistance is determined by resistance testing determining CMV kinase gene UL97 and DNA polymerase gene UL54 for mutations) or death due to CMV.
12 months after transplantation
Secondary Outcomes (8)
Breakthrough CMV infection during CMV prophylaxis with valganciclovir
12 months after transplantation
Therapeutic window
12 months after transplantation
Successful treatment while receiving (val)ganciclovir determined by two consequtive negative viral loads
12 months after transplantation
(Val)ganciclovir for treatment outcomes (1)
12 months after transplantation
(Val)ganciclovir for treatment outcomes (2)
12 months after transplantation
- +3 more secondary outcomes
Study Arms (2)
Prophylaxis
Patients who receive (val)ganciclovir for prophylaxis of cytomegalovirus
Treatment
Patients who receive (val)ganciclovir for treatment of cytomegalovirus
Interventions
Eligibility Criteria
Patients undergoing solid organ or stem cell transplantation are at risk of developing cytomegalovirus (CMV) infection or reactivation. Valganciclovir (oral pro-drug of ganciclovir) prophylaxis is used to postpone CMV infection or reactivation to a later point in the post-transplantation.
You may qualify if:
- Must receive ganciclovir intravenously or valganciclovir orally as routine care
- Must have received a solid organ or stem cell transplant
- Must be be 18 years or older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UMCG
Groningen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan-Willem Alffenaar, PhD
University Medical Center Groningen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Clinical pharmacologist
Study Record Dates
First Submitted
February 7, 2018
First Posted
October 9, 2018
Study Start
May 25, 2018
Primary Completion
November 30, 2019
Study Completion
December 31, 2019
Last Updated
October 10, 2019
Record last verified: 2019-10