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A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

An Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet

NCT06439342•Takeda

View on ClinicalTrials.gov

Summary

The main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus (CMV) infection and how well they tolerate treatment with maribavir. Other aims are to see how effective maribavir is in treating CMV infection and getting rid of the symptoms, the recurrence rate of CMV infection after treatment with maribavir and if the treatment is required again. Researchers will also check for changes (mutations) occurring in the virus which may cause treatment with maribavir to no longer work well or to not work at all (resistance to maribavir). The participants will be treated with maribavir for 8 weeks. During the study, participants will visit their study clinic 18 times.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The participant or the participant's legally acceptable representative is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
•The participant/participant's legally representative has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any study procedures.
•The participant is aged 18 years or older (ie, greater than or equal to \[\>=\] 18 years) at the time of signing the ICF.
•The participant must be of Chinese descent, defined as born in China and having Chinese parents and Chinese maternal and paternal grandparents.
•The participant must be a recipient of hematopoietic stem cell or solid organ transplant.
•The participant must have a documented CMV infection in whole blood or plasma, with a screening value of \>=1,365 International unit per milliliter IU/mL in whole blood or \>=455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to receiving the investigational product with second sample obtained within 5 days prior to receiving the investigational product. The same laboratory and same sample type (whole blood or plasma) must be used for these assessments.
•The participant must have a current CMV infection that is refractory to the most recently administered of the 4 anti-CMV treatment agent(s) eg, intravenous (IV) ganciclovir/oral valganciclovir, IV foscarnet, or IV cidofovir. Refractory is defined as documented failure to achieve greater than (\>) 1 log10 (common logarithm to base 10) decrease in CMV DNA level in whole blood or plasma after a 14 day or longer treatment period with the above 4 agents.
•Participants who have documentation of 1 or more CMV genetic mutations associated with resistance to ganciclovir/valganciclovir, cidofovir, or foscarnet must also meet the definition of refractory CMV infection.
•Have all the following results as part of screening laboratory assessments:
•* Absolute neutrophil count \>=1000 per cubic millimeter (/mm\^3) (1\*10\^9 per liter \[/L\]).
+7 more criteria

Exclusion Criteria

•The participant has CMV disease with central nervous system (CNS involvement) (eg, CMV encephalitis) or ophthalmic involvement (eg, CMV retinitis) as assessed by the investigator at the time of screening.
•That participant has uncontrolled other type of infection as assessed by the investigator on the date of treatment assignment.
•The participant has a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator.
•The participant has a known hypersensitivity to maribavir or to any excipients.
•The participant has severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of investigational product or a GI absorption abnormality that would preclude administration of oral medication.
•The participant has any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the investigational product, or compromise the safety or well-being of the participant.
•The participant is receiving valganciclovir, ganciclovir, cidofovir, foscarnet, letermovir, leflunomide, or artesunate when investigational product is initiated, or anticipated to require one of these agents during the 8-week treatment period.
•The participant requires mechanical ventilation or vasopressors for hemodynamic support at the time of baseline.
•The participant has previously received maribavir.
•The participant has previously completed, discontinued, or have been withdrawn from this study.
+7 more criteria

Locations (12)

Anhui Provincial Hospital(The First Affiliated Hospital of USTC)

Hefei, Anhui, China

Xinqiao Hospital Army Medical University

Chongqing, Chongqing Municipality, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Peking University People's Hospital

Beijing, North China, China

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 16, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

March 2, 2026

Enrollment

ESTIMATED participants

Conditions

Cytomegalovirus (CMV)

Interventions

Maribavir

DRUG

Contacts

Takeda Contact

CONTACT

+1-877-825-3327 medinfoUS@takeda.com

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COMPLETED

A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections

Inclusion Criteria

Exclusion Criteria

Comparison Diagnostic Tests for the Diagnosis of CYTOmegalovirus Organ Disease in Patients With intestinalBOweL Diseases

A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection

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