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Cytomegalovirus (CMV)Phase 3NCT06439342

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

A Phase 3 study testing Maribavir in people with Cytomegalovirus (CMV), run by Takeda at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cytomegalovirus (CMV)
What is being tested?
Maribavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
11 sitesChina
Study dates
16 Dec 2024to 22 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant or the participant's legally acceptable representative is willing and able to understand and fully comply with study procedures and requirements, in the opinion of the investigator.
  • 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.
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  • 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.

Who cannot join

  • The participant has CMV disease with central nervous system (CNS involvement) (eg, CMV encephalitis) or ophthalmic involvement (eg, CMV retinitis) as assessed by the investigator at the time of screening.
  • 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.
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  • 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.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Peking University People's Hospital

    Beijing, North China, 100044

  • Xinqiao Hospital Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • Anhui Provincial Hospital(The First Affiliated Hospital of USTC)

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450004

Other trials in China

About this study

Official title: An Open-label, Single-arm Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet

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.

Being tested
Maribavir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaribavirDrug

    Also called TAK-620

    Maribavir tablets

Study groups in NCT06439342
Study groupRoleWhat they receive
MaribavirExperimentalParticipants will receive maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks.
Receives: Drug: Maribavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE), and Adverse Events of Special interest (AESIs)

    TEAEs will be defined as those with a start date on or after the first dose of study treatment, or with a start date before the date of first dose of study treatment but increasing in severity after the first dose of study treatment. An SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria. AESIs is defined as any adverse event of special interest.

    Measured: From first dose of study drug up to Week 20

  2. Number of Participants With Clinically Significant Changes in Vital Signs

    Vital signs will include temperature, arterial blood pressure (systolic and diastolic) and pulse. Any change in vital signs assessments which will be deemed clinically significant by the investigator will be reported.

    Measured: From first dose of study drug up to Week 20

  3. Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

    Clinical laboratory parameters will include chemistry, hematology, and urinalysis. Any clinical laboratory abnormalities which will be deemed clinically significant by the investigator will be recorded.

    Measured: From first dose of study drug up to Week 20

  4. Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings

    12-lead ECG will be evaluated. Any ECG assessments which will be deemed clinically significant by the investigator will be reported.

    Measured: From first dose of study drug up to Week 20

  5. Number of Participants Who will Discontinue From the Study Drug and Study

    Participants discontinuing the study drug treatment and the study will be reported.

    Measured: From first dose of study drug up to Week 20

Secondary outcomes (18)

  1. Percentage of Participants With Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) (CMV Viremia Clearance) at Week 8

    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (<LLOQ), when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy.

    Measured: At Week 8

  2. Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Weeks 8, 12, 16, and 20

    Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (<LLOQ), when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days, regardless of whether either study-assigned treatment was discontinued before the end of the stipulated 8 weeks of therapy. Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. This outcome measure will be assessed regardless of whether participants complete the stipulated 8 weeks of study-assigned treatment.

    Measured: At Weeks 8, 12, 16 and 20

  3. Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 (After Completion of 8 Weeks Therapy)

    Confirmed CMV viremia clearance will be defined as plasma CMV DNA concentration <LLOQ, when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days (after completion of 8 weeks therapy). Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline.

    Measured: At Week 8

  4. Percentage of Participants With Achievement of CMV Viremia Clearance and CMV Infection Symptom Control After Completion of 8 weeks Therapy Followed by Maintenance of This Treatment Effect Through Weeks 12, 16 and 20

    Confirmed CMV viremia clearance will be defined as plasma CMV DNA concentration <LLOQ, when assessed by CMV Test (Roche COBAS CMV 6800/8800) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days (after completion of 8 weeks therapy). Symptom control is defined as resolution or improvement of tissue invasive CMV disease or CMV syndrome for participants symptomatic at baseline or no new symptoms of tissue invasive CMV disease or CMV syndrome for participants asymptomatic at baseline. The maintenance of treatment effect will be based on the achievement of CMV viremia clearance and symptom control at Week 8 after completion of 8 weeks therapy, followed by maintenance of this treatment effect through Weeks 12, 16 and 20.

    Measured: At Weeks 12, 16 and 20

  5. Percentage of Participants With Recurrence of CMV Viremia During the First 8 Weeks and Through Week 12 to Week 20

    Recurrence of CMV viremia is defined as plasma CMV DNA concentrations greater than or equal to (>=) LLOQ, when assessed by central specialty laboratory, in 2 consecutive plasma samples separated by at least 5 days after achieving confirmed viremia clearance.

    Measured: From first dose of study drug up to Week 8, and through Week 12 to Week 20

  6. Percentage of Participants With Recurrence of CMV Viremia During on Treatment and off Treatment

    Recurrence of CMV viremia is defined as plasma CMV DNA concentrations >= LLOQ, when assessed by central specialty laboratory, in 2 consecutive plasma samples separated by at least 5 days after achieving confirmed viremia clearance. On treatment is the period over which participant received actual dosing (that can be before the stipulated 8 weeks of study-assigned treatment). Off treatment is the period after study treatment.

    Measured: From first dose of study drug up to Week 8 (on treatment) and Week 20 (off treatment)

  7. Percentage of Participants With Recurrence of CMV Viremia Requiring Alternative Treatment After Achieving CMV Viremia Clearance at Study Week 8

    Recurrence of CMV viremia is defined as plasma CMV DNA concentrations >=LLOQ, when assessed by central specialty laboratory, in 2 consecutive plasma samples separated by at least 5 days after achieving confirmed viremia clearance.

    Measured: At Week 8

  8. Percentage of Participants With Mutations in the CMV Genes Conferring Resistance to Maribavir

    Percentage of participants with mutations in the CMV genes conferring resistance to maribavir will be reported.

    Measured: Up to Week 20

  9. Number of Participants With All-cause Mortality During the Study

    All-cause mortality during the study will be reported.

    Measured: Up to Week 20

  10. Maximum Observed Plasma Concentration (Cmax) at Steady State for Maribavir

    Cmax at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8, and 12 hours post-dose

  11. Time to Reach Cmax (Tmax) at Steady State for Maribavir

    Tmax at steady state of maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

  12. Minimum Observed Plasma Concentration (Cmin) for Maribavir

    Cmin of maribavir will be assessed.

    Measured: Pre-dose and at Weeks 1, 4, and 8

  13. Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration Area (AUC0-t) at Steady State for Maribavir

    AUC0-t at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

  14. Area Under the Plasma Concentration-Time Curve Over 1 Dosing Interval of 12 Hours (AUC0-tau) at Steady State for Maribavir

    AUC0-tau at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

  15. Half -life (t1/2) at Steady State for Maribavir

    t1/2 at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

  16. Terminal Elimination Rate Constant (Lambda z) at Steady State for Maribavir

    Lambda z at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

  17. Apparent Volume of Distribution (Vz/F) at Steady State for Maribavir

    Vz/F at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

  18. Apparent Oral Clearance (CL/F) at Steady State for Maribavir

    CL/F at steady state for maribavir will be assessed.

    Measured: Week 1, Day 7: Pre-dose, 0.5, 1.5, 3, 4, 6, 8 and 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study start16 Dec 2024
  3. Primary completion22 Jul 2026
  4. Study completion22 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06439342
Sponsor's protocol ID
TAK-620-3002
Status last verified
Sep 2026
First submitted
28 May 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maribavir in people with Cytomegalovirus (CMV), run by Takeda at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE), and Adverse Events of Special interest (AESIs) (time frame: From first dose of study drug up to Week 20). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06439342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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