The main aim of this study is to check the effectiveness and safety of maribavir for the treatment of CMV infection after HSCT in Chinese patients in real-world settings.
The participants will be treated with maribavir for up to 8 weeks.
Hematopoietic Stem Cell Transplant Recipients
Adult patients with an expected survival of ≥4 weeks.
Confirmed CMV infection, including CMV viremia and CMV disease.
Fully understand the content of the trial, voluntarily participate and complete the trial, and voluntarily sign the informed consent form.
Patients currently participating in other CMV-related clinical studies, such as those receiving anti-CMV drug treatment or involved in CMV vaccine clinical studies.
At screening, liver function tests show: AST > 5×ULN, or ALT > 5×ULN, or total bilirubin ≥ 3.0×ULN.
Patients with psychiatric disorders or severe psychological conditions that may affect the ability to provide informed consent or participate in follow-up consultations.
Participants deemed unsuitable for inclusion by the investigator.
Confirmed CMV infection, including CMV viremia and CMV disease after Hematopoietic Stem Cell Transplant.
Cohort
Prospective
maribavir
DrugMaribavir tablets are administered orally at a dose of 0.4 g per administration (2 tablets of 0.2 g each), twice daily. The recommended duration of treatment is 8 weeks; however, the specific treatment duration should be individualized based on the clinical characteristics of each patient.
CMV viremia clearance rate
The proportion of patients who had confirmed clearance of CMV viremia in plasma (defined as two consecutive CMV-DNA tests below the preemptive treatment threshold after treatment) after 4 weeks of treatment.
CMV disease remission rate
The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment.
Number of participants with AEs
An AE was defined as any event emerging or manifesting at or after the initiation of treatment with a medicinal product or any existing event that worsened in either intensity or frequency following exposure to the medicinal product.
CMV DNA undetected time
The time when CMV DNA was first detected under the limit of detection in plasma.
CMV viremia clearance at the end of 8 weeks of treatment
The proportion of patients with confirmed clearance of CMV viremia in plasma at the end of 8 weeks of treatment.
Number of participants with all-cause mortality
All-cause mortality means death due to any cause.
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This trial is not recruiting at the moment. You can still explore other options:
