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

NCT07141095 | Not Yet Recruiting

• 1 other identifier: IIT2025003
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Infections, Cytomegalovirus

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Number of participants with AEs

  From first dose of study drug up to week 8

• CMV DNA undetected time

  From first dose of study drug up to week 8

• CMV viremia clearance at the end of 8 weeks of treatment

  At Week 8

• Number of participants with all-cause mortality

  From first dose of study drug up to week 8

Study Arms (1)

Participants with CMV Infection

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

Drug: maribavir

Interventions

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.

Participants with CMV Infection

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Confirmed CMV infection, including CMV viremia and CMV disease after Hematopoietic Stem Cell Transplant.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

maribavir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Jiang Erlie, doctor

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Pang Aiming, doctor

CONTACT

+86-13820398091; pangaiming@ihcams.ac.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 26, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-07

Locations

CN (1)