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

NCT ID: NCT07141095

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-25

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infections, Cytomegalovirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with CMV Infection

Participants will receive maribavirv tablets, 400 mg, orally twice a day(bid) for up to 8 weeks treatment period.

maribavir

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Central Contacts

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Jiang Erlie, doctor

Role: CONTACT

+86-15122538106

Pang Aiming, doctor

Role: CONTACT

+86-13820398091

Facility Contacts

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Erlie Jiang

Role: primary

+86-15122538106

Other Identifiers

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IIT2025003

Identifier Type: -

Identifier Source: org_study_id

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