Not yet recruiting NCT07141095
A Prospective Single-Arm Observational Study of Maribavir for the Treatment of Post Hematopoietic Stem Cell Transplantation Cytomegalovirus Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: maribavir.
- Who it may be relevant to
- Registry conditions: Infections, Cytomegalovirus. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Drug maribavir
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.
Primary outcome measures
- CMV viremia clearance rate [Time frame: At Week 4]
- CMV disease remission rate [Time frame: At Week 4]
Secondary outcome measures (4)
- Number of participants with AEs [Time frame: From first dose of study drug up to week 8]
- CMV DNA undetected time [Time frame: From first dose of study drug up to week 8]
- CMV viremia clearance at the end of 8 weeks of treatment [Time frame: At Week 8]
- Number of participants with all-cause mortality [Time frame: From first dose of study drug up to week 8]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Participants who meet any of the following criteria are not eligible for this study:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT07141095 · IIT2025003