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NCT Number: NCT07141095

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

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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Key information

Conditions

Infections, Cytomegalovirus Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Tianjin, Tianjin Municipality, China

Location contact

Erlie Jiang

CONTACT

[email protected]

+86-15122538106

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. CMV viremia clearance rate

    Time frame: 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.

  2. CMV disease remission rate

    Time frame: At Week 4

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

Secondary outcomes

  1. Number of participants with AEs

    Time frame: 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.

  2. CMV DNA undetected time

    Time frame: 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.

  3. CMV viremia clearance at the end of 8 weeks of treatment

    Time frame: At Week 8

    The proportion of patients with confirmed clearance of CMV viremia in plasma at the end of 8 weeks of treatment.

  4. Number of participants with all-cause mortality

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

    All-cause mortality means death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiang Erlie, doctor

CONTACT

[email protected]

+86-15122538106

Pang Aiming, doctor

CONTACT

[email protected]

+86-13820398091

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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