Actively Recruiting
A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
Led by Takeda · Updated on 2026-03-02
20
Participants Needed
12
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally acceptable representative is willing and able to comply with study procedures and requirements.
- Provided signed informed consent and any required privacy authorization before any study procedures.
- Aged 18 years or older at the time of signing consent.
- Of Chinese descent, defined as born in China with Chinese parents and maternal and paternal grandparents.
- Recipient of hematopoietic stem cell or solid organ transplant.
- Documented CMV infection in whole blood or plasma with specified viral load levels in two consecutive assessments within 14 days prior to treatment.
- Current CMV infection refractory to treatment with ganciclovir, valganciclovir, foscarnet, or cidofovir, defined by failure to reduce CMV DNA by >1 log10 after at least 14 days of treatment.
- If CMV genetic mutations associated with resistance are documented, must also meet refractory infection definition.
- Screening lab results must show absolute neutrophil count ≥1000/mm³, platelet count ≥25,000/mm³, hemoglobin ≥8 g/dL, and estimated glomerular filtration rate ≥30 mL/min/1.73 m².
- Life expectancy of at least 8 weeks.
- Body weight of at least 35 kg.
- Female participants must be of nonchildbearing potential or have a negative pregnancy test; sexually active males and nonpregnant females must comply with contraceptive requirements.
- Able to swallow tablets or receive tablets crushed and/or dispersed in water via nasogastric or orogastric tube.
You will not qualify if you...
- CMV disease involving central nervous system or eyes at screening.
- Uncontrolled infections other than CMV at treatment assignment.
- History of alcohol or drug abuse interfering with treatment compliance.
- Known allergy to maribavir or any excipients.
- Severe vomiting, diarrhea, or gastrointestinal illness within 24 hours before first dose or GI absorption issues preventing oral medication.
- Any significant medical or surgical condition that may interfere with study results or participant safety.
- Receiving valganciclovir, ganciclovir, cidofovir, foscarnet, letermovir, leflunomide, or artesunate at study start or expected to need them during treatment.
- Requires mechanical ventilation or vasopressors at baseline.
- Previous treatment with maribavir.
- Previously completed, discontinued, or withdrawn from this study.
- Received investigational anti-CMV agents within 30 days before study or any investigational agent/device within 30 days before study.
- Elevated liver enzymes or bilirubin above set limits at screening (except Gilbert's syndrome or biopsy-confirmed CMV hepatitis).
- Known positive HIV status; must have recent negative HIV test.
- Active malignancy except nonmelanoma skin cancer or relapse/progression of underlying malignancy.
- Undergoing treatment for acute or chronic hepatitis B or C.
- Pregnant, expecting to conceive, or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Anhui Provincial Hospital(The First Affiliated Hospital of USTC)
Hefei, Anhui, China, 230001
Actively Recruiting
2
Xinqiao Hospital Army Medical University
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
4
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450004
Actively Recruiting
6
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
7
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
8
Peking University People's Hospital
Beijing, North China, China, 100044
Actively Recruiting
9
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
10
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
11
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
12
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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