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New treatment option for Cytomegalovirus Infection
Official title Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
ClinicalTrials.gov ID: NCT06334497
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cytomegalovirus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eligible for treatment with oral valganciclovir, per investigator's judgment
You likely can't join if
- Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to antiviral treatment, to the best knowledge of...
- 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...
- 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...
- Have a severe chronic liver disease (Child-Pugh Class C)
See the full eligibility 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...
- 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...
- Have life expectancy of ≥ 8 weeks
- French speaking
- Affiliated to social security regime or an equivalent system
- Informed consent and signed
- 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...
- 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...
- 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.
- Be pregnant or breastfeeding.
- Have received anti-CMV vaccine at any time.
- Be receiving leflunomide or artesunate when study treatment is initiated.
- Be receiving strong inhibitors or inducers of hepatic CYP enzymes including rifampicin, phenytoin, clarithromycin, ritonavir, or cobicistat or St. John's wort (Hypericum perforatum) when study treatment is initiated.
- Be receiving efavirenz, etravirine, nevirapine, lopinavir, pimozine, ergot alkaloids, dabigatran, atorvastatine (at a daily dose \> 20mg, and / or if co-administered with cyclosporin A), pravastatin ( if co-administered...
- Have known hereditary intolerance to galactose, with lactose Lapp deficiency, glucose or galactose malabsorption syndrome.
- Have known hypersensitivity to letermovir or to an excipient for a study treatment.
- Have any clinically significant medical or surgical condition that in the investigator's opinion could interfere with the interpretation of study results, contraindicate the administration of the assigned study...
- Participation to another clinical trial on medicinal products for human use
- Have an absolute neutrophil count less than 500 cells/µl, or platelet count less than 25,000/µl, or haemoglobin less than 8 g/dl
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
- Paris, Île-de-France Region, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France; Paris, Île-de-France Region, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.