liver transplant
Conditions
Interventions
Control group:Acyclovir
Experimental group:Letemovir
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender is not limited; 2. Undergoing the first liver transplant surgery; 3. Randomization will be carried out from day 0 (i.e., the day of transplantation) to day 10 (including 10 days) after liver transplantation surgery; 4. Obtain informed consent signed by the patient and his family.
Exclusion criteria
Exclusion criteria: 1. Previous solid organ transplantation or hematopoietic stem cell transplantation; 2. Receive multiple organ transplants; 3. History of cytomegalovirus or suspected cytomegalovirus within 6 months before randomization, such as positive serological test CMV IgM or positive donor CMV IgM; 4. Evidence of CMV viremia at any time from signing the ICF or transplant surgery (whichever is earlier) to randomization; 5. Suspected or known hypersensitivity reactions to the active or inactive ingredients of lenterovir preparations, acyclovir preparations, ganciclovir preparations; 6. Receiving renal replacement therapy, such as hemodialysis, peritoneal dialysis, at randomization. (Note: Patients who have been on dialysis within 10 days of transplant but are not on dialysis at the time of randomization or are expected to stop dialysis may be enrolled if all other inclusion/exclusion criteria are met; 7. Post-transplant creatinine clearance (CrCl) 5× ULN; or serum total bilirubin >2.5× ULN; 14. Received or planned to receive any of the following treatments during the study within 30 days prior to randomization: (1) Cidofovir; (2) CMV-specific immunoglobulin; (3) Any trial treatment with CMV antiviral drugs/biologics; 15. Has received or plans to receive any of the following treatments during the study within 10 days prior to randomization: (1) Laitemovir; (2) ganciclovir; (3) Valganciclovir; (4) phosphonic acid; (5) Acyclovir (dose greater than the recommended dose for HSV/VZV prophylaxis, > 3200 mg PO/day, or >25 mg/kg IV/day); (6) Valacyclovir (dose greater than the recommended dose for HSV/VZV prophylaxis, such as >3000 mg PO/day); (7) Famciclovir (dose greater than the recommended dose for HSV/VZV prophylaxis, > 1500 mg PO/day); 16. Subjects are expected to receive traditional Chinese medicine or herbal treatment during the study treatment period and within 14 days after the study drug; 17. Is currently participating in, or has participated in a study of a non-approved investigational compound or device within 28
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically significant CMV infection within 24 weeks post-transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of all AEs;Incidence of relapsed/refractory CMV infection;Time to onset of CMV infection within 24 weeks of transplantation;Other clinical outcomes included infection (bacterial, fungal, non-CMV virus ), rejection, graft failure, and mortality; | — |
Countries
China
Contacts
Public ContactJian Zhou
Zhongshan Hospital, Fudan University
Outcome results
None listed