A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection

N/ANot Yet RecruitingNCT07141095

Institute of Hematology & Blood Diseases Hospital, China17 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Infections, Cytomegalovirus

Interventions

maribavirDRUG

Maribavir 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.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Hematopoietic Stem Cell Transplant Recipients 1. Adult patients with an expected survival of ≥4 weeks. 2. Confirmed CMV infection, including CMV viremia and CMV disease. 3. Fully understand the content of the trial, voluntarily participate and complete the trial, and voluntarily sign the informed consent form. Exclusion Criteria: * Participants who meet any of the following criteria are not eligible for this study: 1. Patients currently participating in other CMV-related clinical studies, such as those receiving anti-CMV drug treatment or involved in CMV vaccine clinical studies. 2. At screening, liver function tests show: AST \> 5×ULN, or ALT \> 5×ULN, or total bilirubin ≥ 3.0×ULN. 3. Patients with psychiatric disorders or severe psychological conditions that may affect the ability to provide informed consent or participate in follow-up consultations. 4. Participants deemed unsuitable for inclusion by the investigator.

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: At Week 4

CMV disease remission rate

The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment.

Time frame: At Week 4

Secondary Outcomes

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.

Time frame: From first dose of study drug up to week 8

CMV DNA undetected time

The time when CMV DNA was first detected under the limit of detection in plasma.

Time frame: From first dose of study drug up to week 8

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.

Time frame: At Week 8

Number of participants with all-cause mortality

All-cause mortality means death due to any cause.

Time frame: From first dose of study drug up to week 8