Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections (NCT06334497) | Clinical Trial Compass
RecruitingPhase 3
Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
France80 participantsStarted 2024-08-14
Plain-language 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 investigator's judgment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Weight ≥ 30 kg
✓. Kidney transplant recipient
✓. Have a documented CMV infection or disease, with (i) a screening value of CMV DNA ≥ 3000 IU/mL in whole blood or plasma in 2 consecutive assessments separated by ≥ 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR). Both samples should be taken within 14 days prior to randomization with the second sample obtained within 5 days prior to randomization OR (ii) a screening value of CMV DNA ≥ 30000 IU/mL in whole blood or plasma, as determined by local laboratory quantitative polymerase chain reaction (qPCR), in 1 sample obtained within 5 days prior to randomization
✓. Eligible for treatment with oral valganciclovir, per investigator's judgment
✓. For patients of childbearing age (following menarche): negative bHCG and effective method of contraception (sexual abstinence, hormonal contraception containing ethinylestradiol and levonorgestrel, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) until 30 days after the end of relevant systemic exposure (week 13).
✓. Have life expectancy of ≥ 8 weeks
✓. French speaking
Exclusion criteria
✕. Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to antiviral treatment, to the best knowledge of the investigator.
✕. Have a CMV infection that is known to be genotypically resistant to valganciclovir and/or letermovir on documented evidence.
✕. Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir or maribavir) for the current CMV infection for longer than 72 hours. However, patients experiencing CMV infection while receiving ganciclovir or valganciclovir prophylaxis (i.e. at prophylactic dosages) or letermovir prophylaxis can be included.
✕. Have an eGFR \< 15 mL/min/1.73m² (using the CKD-EPI Creatinine Equation (2009)).
✕. Have serum aspartate aminotransferase (AST) ≥ 5 times higher than the upper limit of normal (ULN), or serum alanine aminotransferase (ALT) ≥ 5 times the ULN, or total bilirubin ≥ 3 times the ULN (except for documented Gilbert's syndrome). Note: Subjects with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT ≥ 5 times ULN
✕. Have a severe chronic liver disease (Child-Pugh Class C)
✕. Have a known human immunodeficiency virus (HIV) infection with plasma HIV RNA ≥ 50 copies/mL within the 3 months before inclusion.
✕. Require mechanical ventilation or vasopressors for hemodynamic support.