Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
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.
| Condition(s) | Cytomegalovirus Infection |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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 | Inclusion Criteria: 1. Age ≥ 18 years 2. Weight ≥ 30 kg 3. Kidney transplant recipient 4. 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 5. Eligible for treatment with oral valganciclovir, per investigator's judgment 6. For patients of childbe |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
| Locations | Paris, France; Paris, Île-de-France Region, France; Paris, Île-de-France Region, France; Paris, Île-de-France Region, France; Paris, Île-de-France Region, France |
| Start date | 2024-08-14 |
| NCT ID | NCT06334497 |
| Official listing | https://clinicaltrials.gov/study/NCT06334497 |