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

Institute of Hematology & Blood Diseases Hospital, China

Status

Not yet enrolling

Conditions

Infections, Cytomegalovirus

Treatments

Drug: maribavir

Study type

Observational

Funder types

Other

Identifiers

NCT07141095

IIT2025003

Details and patient eligibility

About

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.

Enrollment

17 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.