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

Not yet recruiting

• Conditions: Infections, Cytomegalovirus
• Interventions: Drug: maribavir

• Registration Number: NCT07141095
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-26
• Last Update Posted: 2025-08-26
• Study Start: 2025-09-25
• Primary Completion: 2026-10-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with CMV Infection	maribavir	Participants will receive maribavirv tablets, 400 mg, orally twice a day(bid) for up to 8 weeks treatment period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin Municipality, China