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

NCT06439342 | Recruiting Phase 3

• 1 other identifier: TAK-620-3002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Cytomegalovirus (CMV)

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE), and Adverse Events of Special interest (AESIs)

  TEAEs will be defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria. AESIs is defined as any adverse event of special interest.

  From first dose of study drug up to Week 20

• Number of Participants With Clinically Significant Changes in Vital Signs

  Vital signs will include temperature, arterial blood pressure (systolic and diastolic) and pulse. Any change in vital signs assessments which will be deemed clinically significant by the investigator will be reported.

  From first dose of study drug up to Week 20

• Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

  Clinical laboratory parameters will include chemistry, hematology, and urinalysis. Any clinical laboratory abnormalities which will be deemed clinically significant by the investigator will be recorded.

  From first dose of study drug up to Week 20

• Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

  12-lead ECG will be evaluated. Any ECG assessments which will be deemed clinically significant by the investigator will be reported.

  From first dose of study drug up to Week 20

• Number of Participants Who will Discontinue From the Study Drug and Study

  Participants discontinuing the study drug treatment and the study will be reported.

  From first dose of study drug up to Week 20

Secondary Outcomes (18)

• Percentage of Participants With Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) (CMV Viremia Clearance) at Week 8

  At Week 8

• Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Weeks 8, 12, 16, and 20

  At Weeks 8, 12, 16 and 20

• Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 (After Completion of 8 Weeks Therapy)

  At Week 8

• Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control After Completion of 8 weeks Therapy Followed by Maintenance of This Treatment Effect Through Weeks 12, 16 and 20

  At Weeks 12, 16 and 20

• Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks and Through Week 12 to Week 20

  From first dose of study drug up to Week 8, and through Week 12 to Week 20

Study Arms (1)

Maribavir

EXPERIMENTAL

Participants will receive maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.

Drug: Maribavir

Interventions

Maribavir DRUG

Maribavir tablets

Also known as: TAK-620

Maribavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[/L\]).
• Platelet count \>= 25,000/mm\^3 (25\*10\^9/L)
• Hemoglobin \>= 8 grams per deciliter (g/dL)
• Estimated glomerular filtration rate \>= 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as assessed by Modification of Diet in Renal Disease (MDRD) formula.
• The participant must have life expectancy of at least 8 weeks.
• The participant has a body weight of at least 35 kilogram (kg).

You may not qualify if:

• 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.
• The participant has received any investigational agent with known anti-CMV activity within 30 days before initiation of investigational product or CMV vaccine at any time.
• The participant has received any investigational agent or device within 30 days before initiation of investigational product.
• The participant has serum aspartate aminotransferase (AST) \>5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) \>5 times ULN at screening, or total bilirubin \>=3.0 × ULN at screening (except for documented Gilbert's syndrome), by a local laboratory. Note: Participants with biopsy confirmed CMV hepatitis will not be excluded from study participation despite AST or ALT \>5 times ULN at screening.
• The participant has known (previously documented) positive results for human immunodeficiency virus (HIV). Participant must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.
• The participant has active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which hematopoietic stem-cell transplantation (HSCT) or solid organ transplant (SOT) was performed), as determined by the investigator, are not to be enrolled.

Sponsors & Collaborators

• Takeda: lead

Study Sites (12)

Anhui Provincial Hospital(The First Affiliated Hospital of USTC)

Hefei, Anhui, 230001, China

RECRUITING

Xinqiao Hospital Army Medical University

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450004, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Peking University People's Hospital

Beijing, North China, 100044, China

RECRUITING

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

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
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MeSH Terms

Interventions

maribavir

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (12)