Actively Recruiting
A Study Evaluating Safety, Tolerability, Efficacy, and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus Infections Resistant to Standard Treatments
Led by Takeda · Updated on 2026-03-02
20
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of maribavir in Chinese adults who have received hematopoietic stem cell or organ transplants and have cytomegalovirus (CMV) infections that are resistant or unresponsive to standard treatments. The study also aims to understand the recurrence rate of CMV after maribavir treatment and monitor for viral mutations that could cause resistance to the drug. Participants will take maribavir tablets orally, 400 mg twice daily, for up to 8 weeks. The study is open-label and single-arm, meaning all participants receive maribavir without placebo comparison. Treatment effects and drug levels in the body will be closely observed during and after the treatment period. During the study, participants will visit the clinic 18 times for evaluations including vital signs, laboratory tests, and electrocardiograms. Researchers will track side effects, blood levels of the virus, symptom control, and any return of infection up to 20 weeks from starting the drug. The study also includes detailed blood sampling to measure how maribavir is processed in the body.
CONDITIONS
Brief Title
A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legal representative can understand and comply with study procedures
- Signed informed consent provided before any study procedures
- Age 18 years or older at time of consent
- Of Chinese descent (born in China with Chinese parents and grandparents)
- Recipient of hematopoietic stem cell or solid organ transplant
- Documented CMV infection with specified viral load levels in blood or plasma
- CMV infection refractory to recent treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet
- Required blood lab results within specified limits (neutrophils, platelets, hemoglobin, kidney function)
- Life expectancy of at least 8 weeks
- Body weight of at least 35 kg
- Women of childbearing potential must have negative pregnancy test; contraception required during treatment and 90 days after
- Ability to swallow tablets or receive crushed tablets via feeding tube
You will not qualify if you...
- CMV disease involving central nervous system or eyes
- Uncontrolled infections other than CMV
- History of alcohol or drug abuse affecting compliance
- Known allergy to maribavir or its ingredients
- Severe gastrointestinal illness affecting drug absorption
- Medical or surgical conditions interfering with study or safety
- Concurrent use or anticipated need for certain anti-CMV drugs during treatment
- Requirement for mechanical ventilation or blood pressure support at baseline
- Previous treatment with maribavir or prior participation in this study
- Recent use of investigational anti-CMV agents or vaccines
- High liver enzyme levels or bilirubin above limits (except Gilbert’s syndrome or confirmed CMV hepatitis)
- Known HIV infection or lack of recent negative HIV test
- Active cancer except nonmelanoma skin cancer
- Treatment for acute or chronic hepatitis B or C
- Pregnant, planning pregnancy, or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive maribavir tablets orally twice a day for up to 8 weeks to treat CMV infections resistant to standard treatments.
Visits occur at Weeks 1, 4, and 8 with additional pharmacokinetic sampling on Week 1, Day 7
Duration - Up to 12 weeks after treatment (through Week 20)
Participants are monitored for safety, efficacy, and CMV infection status after completing treatment, up to Week 20.
Visits at Weeks 12, 16, and 20
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
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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