Cytomegalovims infections
Conditions
Interventions
The experimental group (letermovir group):The application of letermovir for the prevention of CMV infection after liver transplantation
Control group (placebo group):Application of placebo to prevent CMV infection after liver transplantation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age: 18 - 70 years old, gender not restricted; 2) Have undergone the first liver transplantation surgery; 3) Be randomly grouped one day before the liver transplantation surgery; 4) Understand and voluntarily participate in this study, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) prior solid organ transplantation or hematopoietic stem cell transplantation; 2) receiving multiple organ transplantation; 3) history of cytomegalovirus or suspected cytomegalovirus within 6 months before randomization, if positive for CMV IgM serology; 4) evidence of CMV viremia at any time from signing the ICF or transplantation procedure, whichever came first, until randomization; 5) patients with suspected or known hypersensitivity to the active or inactive components of letemovir preparations; 6) were receiving renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) at randomization. (Note: Dialysis was performed within 10 days of transplantation if all other inclusion/exclusion criteria were met, but not at the time of randomization Patients who were undergoing dialysis or were expected to discontinue dialysis were eligible). 7) Creatinine clearance (CrCl) 5×ULN; Or serum total bilirubin > 2.5×ULN; 14) received or planned to receive any of the following treatments within 30 days before randomization during the study: cidofovir; Cmv-specific immunoglobulin; Any trial treatment with CMV antiviral drugs/biologics; 15) within 10 days before randomization had received or were scheduled to receive any of the following treatments during the study: letemovir; Ganciclovir; Valganciclovir; Sodium foscarnet; Acyclovir (at doses greater than the recommended dose for HSV/VZV prophylaxis, > 3200 mgPO/ day, or > 25 mg/kg IV/ day); Valacyclovir (at doses greater than the recommended dose for HSV/VZV prophylaxis, such as > 3000 mgPO/ day); Famciclovir (at a dose greater than the recommended dose for HSV/VZV prophylaxis, >1500 mg PO/ day); 16) subjects are expected to receive TCM or herbal treatment during and within 14 days after the study medication; 17) are currently participating in or have participated in a study of an unapproved investigational compound or device within 28 days before the start of study dosing or 5 times the half-life of the investigational compound, whichever is longer. or Subjects who had received tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of CMV disease at the 14th week after transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of CMV viremia at the 14th week after transplantation;The incidence of CMV disease at the 28th week after transplantation;The incidence of CMV viremia at the 28th week after transplantation;The time of CMV infection outbreak 28 weeks after transplantation;The incidence of recurrent/refractory CMV infection;Other clinical outcomes include infections (bacterial, fungal, non-CMV viral infections), rejection reactions, graft failure, and mortality.;All the occurrence rates and severity levels of AE; | — |
Countries
China
Contacts
Public ContactJiayin Yang
West China Hospital of Sichuan University
Outcome results
None listed