Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334497
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-15
Brief Title:
Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Letermovirvalganciclovir Combination Versus Valganciclovir Monotherapy for Treatment of Cytomegalovirus CMV Infections in Kidney Transplant Recipients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUCY-1
Brief Summary:
The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy in association with valganciclovir in renal transplant recipients with CMV DNAemia requiring valganciclovir treatment per investigators judgment
Detailed Description:
Ganciclovir and valganciclovir are the drugs of choice to treat CMV infections and diseases in immunocompromised patients However valganciclovir does not seem to be a panacea and its modest efficacy and dose-limiting toxicities limit effectiveness More valganciclovir use may drive development of drug-resistant infections particularly in immunocompromised patients
An in vitro study suggested additive effects for the combination of letermovir with all approved drugs for treatment or prevention of CMV infections Investigators hypothesis is that letermovir plus valganciclovir dual therapy will inhibit CMV replication faster than valganciclovir monotherapy More the use of antiviral dual therapy aims to decrease the risk of drug resistance mutations selection as previously demonstrated in several other viral infections
In this study renal transplant recipients with CMV DNAemia requiring valganciclovir will be randomized to receive either letermovir plus valganciclovir or letermovir placebo plus valganciclovir until reaching the treatment success or the treatment failure criteria up to 12 weeks
Treatment success will be defined as from Week-3
eradication of CMV DNAemia defined as CMV DNAemia in whole blood below lower limit of quantification LLOQ 200 IUmL on 1 blood sample
AND resolution of clinical symptoms of CMV disease if appropriate
Treatment failure will be defined as fulfilling at least one criterion among
failure to achieve a decrease of CMV DNAemia 1 log10 IUmL at Week-3 compared to the baseline CMV DNAemia
persistence of CMV DNAemia LLOQ 200 IUml at Week-12
absence of improved CMV disease at Week-3
An in vitro study suggested additive effects for the combination of letermovir with all approved drugs for treatment or prevention of CMV infections Investigators hypothesis is that letermovir plus valganciclovir dual therapy will inhibit CMV replication faster than valganciclovir monotherapy More the use of antiviral dual therapy aims to decrease the risk of drug resistance mutations selection as previously demonstrated in several other viral infections
In this study renal transplant recipients with CMV DNAemia requiring valganciclovir will be randomized to receive either letermovir plus valganciclovir or letermovir placebo plus valganciclovir until reaching the treatment success or the treatment failure criteria up to 12 weeks
Treatment success will be defined as from Week-3
eradication of CMV DNAemia defined as CMV DNAemia in whole blood below lower limit of quantification LLOQ 200 IUmL on 1 blood sample
AND resolution of clinical symptoms of CMV disease if appropriate
Treatment failure will be defined as fulfilling at least one criterion among
failure to achieve a decrease of CMV DNAemia 1 log10 IUmL at Week-3 compared to the baseline CMV DNAemia
persistence of CMV DNAemia LLOQ 200 IUml at Week-12
absence of improved CMV disease at Week-3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-506216-40-00 | OTHER | EU CT | None |