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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with CMV Infection | Participants will receive maribavirv tablets, 400 mg, orally twice a day(bid) for up to 8 weeks treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maribavir | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 4 |
| CMV disease remission rate | The proportion of patients who achieved remission of CMV disease after 4 weeks of treatment. | At Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first dose of study drug up to week 8 |
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Inclusion Criteria:
Hematopoietic Stem Cell Transplant Recipients
Exclusion Criteria:
Participants who meet any of the following criteria are not eligible for this study:
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Confirmed CMV infection, including CMV viremia and CMV disease after Hematopoietic Stem Cell Transplant.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Erlie, doctor | Contact | +86-15122538106 | jiangerlie@ihcams.ac.cn | |
| Pang Aiming, doctor | Contact | +86-13820398091 | pangaiming@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin | Tianjin Municipality | China |
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| CMV DNA undetected time |
The time when CMV DNA was first detected under the limit of detection in plasma. |
| 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. | At Week 8 |
| Number of participants with all-cause mortality | All-cause mortality means death due to any cause. | From first dose of study drug up to week 8 |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C400401 | maribavir |
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