What is maribavir studying for cytomegalovirus (CMV) infections?

Maribavir is being studied to see how safe and well-tolerated it is in adults with CMV infections after stem cell or organ transplants, especially when other treatments have not worked. The study also evaluates how effectively maribavir clears the virus and controls symptoms. Takeda is sponsoring this research to better understand treatment options for CMV infections.

Who may be eligible for this cytomegalovirus clinical trial?

Adults 18 years or older of Chinese descent who have had a stem cell or organ transplant and a confirmed CMV infection not responding to certain standard antiviral drugs may be eligible. Participants must be able to swallow tablets and meet certain health criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this cytomegalovirus clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits are the participant's responsibility and may vary. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06439342

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

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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

Research Team

Takeda Contact

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