Infections, Cytomegalovirus
Conditions
Brief summary
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
DRUGmaribavir
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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMV viremia clearance rate | At Week 4 | 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 | At Week 4 | The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs | From first dose of study drug up to week 8 | 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 | From first dose of study drug up to week 8 | 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 | At Week 8 | 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 | From first dose of study drug up to week 8 | All-cause mortality means death due to any cause. |
Countries
China
Contacts
Primary ContactJiang Erlie, doctor
Backup ContactPang Aiming, doctor
Outcome results
None listed