A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
NCT ID: NCT06439342
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
20 participants
INTERVENTIONAL
2024-12-16
2026-12-31
Brief Summary
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The participants will be treated with maribavir for 8 weeks.
During the study, participants will visit their study clinic 18 times.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Maribavir
Participants will receive maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.
Maribavir
Maribavir tablets
Interventions
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Maribavir
Maribavir tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
* The female participant either be of nonchildbearing potential, or if of childbearing potential then have a negative serum human chorionic gonadotropin (hCG) or beta-hCG (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating female participants who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the investigational product administration period and for 90 days after the last dose of investigational product.
* The participant must be able to swallow tablets, or receive tablets crushed and/or dispersed in water via a nasogastric or orogastric tube.
Exclusion Criteria
* 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.
* The participant is undergoing treatment for acute or chronic hepatitis C and hepatitis B.
* The participant is pregnant or expecting to conceive or nursing/breastfeeding.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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To obtain more information about this study, click this link
Other Identifiers
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TAK-620-3002
Identifier Type: -
Identifier Source: org_study_id
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