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TAK-620-3002
Will Be Recruiting

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

Clinicaltrials.gov
#NCT06439342

About this clinical trial

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.

CN
Interventional Phase 3 clinical trial.

At a glance

What medical conditions are being studied?

Cytomegalovirus (CMV)

What is the clinical trial testing?

Maribavir

How many participants are being enrolled?

20

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Mar 2025 - Feb 2027

How long is participation in the clinical trial?

Participants can be in this study for up to 22 weeks.

Key requirements

Sexes

All

Age

18+ years

Healthy volunteers?

No

Entry criteria

Men and women aged ≥ 18 years can participate in this study.
Must be of Chinese descent. This means participants must be born in China and have Chinese parents and grandparents (on both the mother’s and the father’s side).
Must have had a stem cell transplant or an organ transplant.
Must have a CMV infection.
Must weigh at least 35 kg.
Cannot have previously been treated with Maribavir.
Cannot have active cancer (other than skin cancer).
Additional entry criteria will be discussed with the study doctor.

Locations