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Cytomegalovirus (CMV)Phase 3NCT05137717

A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection

A Phase 3 study testing Maribavir in people with Cytomegalovirus (CMV), run by Takeda at 20 sites in Japan.

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 the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it. Read more about this study

Who is it for?
Ages 16 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
41 participants
Where
20 sitesJapan
Study dates
18 Jan 2022to 27 Jun 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Be Japanese with Japanese nationality, >=16 years of age at the time of consent.
  • Be a recipient of HSCT or SOT that is functioning at the time of Screening.
  • Have a documented CMV infection with a screening value of >455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by a central specialty laboratory qPCR or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to first dose of study treatment with the second sample obtained within 5 days prior to first dose of study treatment at Visit 2/Day 0.
  • Have the current CMV infection after HSCT or SOT, either primary or reactivation, which, in the investigator's opinion, requires treatment and have any of the following.
  • Asymptomatic participants: The subjects do not have CMV tissue-invasive disease or CMV syndrome (SOT subjects only) at Baseline, as determined by the investigator according to the criteria specified by Ljungman et al., 2017.
  • Refractory or resistant participants: The participant must have a current CMV infection that is refractory to the most recently administered of the anti-CMV treatment agent(s). Refractory is defined as documented failure to achieve >1 log10 (common logarithm to base 10) decrease in CMV DNA level in plasma after a 14 day or longer treatment period with IV ganciclovir/oral valganciclovir, or IV foscarnet.
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  • Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
  • Absolute neutrophil count >=1,000/mm^3 (1.0 × 10^9/L)
  • Platelet count >=25,000/mm^3 (25 × 10^9/L)
  • Hemoglobin >=8 g/dL
  • Estimated creatinine clearance >=30 mL/minute (estimated glomerular filtration rate by Modification of Diet in Renal Disease)
  • Be able to swallow tablets.
  • Have life expectancy of >=8 weeks.
  • Weigh >=40 kg.

Who cannot join

  • Have central nervous system (CNS) CMV tissue-invasive disease or CMV retinitis as assessed by the investigator at the time of Screening and prior to administration at Visit 2/Day 0.
  • Be receiving valganciclovir, ganciclovir, foscarnet, or letermovir when study treatment is initiated, or anticipated to require 1 of these agents during the 8-week treatment period.
  • NOTE: Participants receiving letermovir must discontinue 3 days prior to first dose of study treatment. Ganciclovir, valganciclovir, and foscarnet must be discontinued prior to the first dose of study treatment.
  • Have known hypersensitivity to the active substance or to an excipient of the study treatments.
  • Have severe vomiting, diarrhea, or other severe GI illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
  • Require mechanical ventilation or vasopressors for hemodynamic support at the time of Baseline.
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  • Pregnant or nursing female.
  • Have received any investigational agent (including CMV-specific T-cells) with known anti-CMV activity within 30 days before initiation of the study treatment at any time.
  • Have previously received maribavir.
  • Have 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), as analyzed by local or central laboratory.
  • Have known (previously documented) positive results for HIV. Participants 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.
  • Have 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 HSCT or SOT was performed), as determined by the investigator, are not to be enrolled.
  • Be undergoing treatment for acute or chronic hepatitis C.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Japan20 sites

  • Chiba University Hospital

    Chiba

  • Kyushu University Hospital

    Fukuoka, Fukuoka

  • Fukushima Medical University Hospital

    Fukushima

  • Imamura General Hospital

    Kagoshima, Kagoshima-ken

  • Kyoto University Hospital

    Kyoto

  • The Jikei University Hospital

    Minato-ku, Tokyo

  • Toranomon Hospital

    Minato-ku, Tokyo

  • Okayama University Hospital

    Okayama

  • Osaka International Cancer Institute

    Osaka, Osaka

  • Osaka Metropolitan University Hospital

    Osaka

  • Jichi Medical University Saitama Medical Center

    Saitama

  • Hokkaido University Hospital

    Sapporo, Hokkaido

  • Sapporo City General Hospital

    Sapporo, Hokkaido

  • Sapporo Hokuyu Hospital

    Sapporo, Hokkaido

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi

  • Keio University Hospital

    Shinjuku-ku, Tokyo

  • Yochomachi Clinic

    Shinjuku-ku, Tokyo

  • Osaka University Hospital

    Suita, Osaka

  • Ehime University Hospital

    Tōon, Ehime

  • University of Tsukuba Hospital

    Tsukuba, Ibaraki

Other trials in Japan

About this study

Official title: A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoietic Stem Cell Transplant (HSCT) or Solid Organ Transplant (SOT)

The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting side effects from it.

Japanese recipients of a hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) will take Maribavir tablets two times a day for 8 weeks in this study.

During the study, participants will visit their study clinic 18 times as a maximum.

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 SHP620, TAK-620

    Maribavir tablets

Study groups in NCT05137717
Study groupRoleWhat they receive
MaribavirExperimentalMaribavir 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. Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8

    The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the lower limit of quantification (LLOQ) (that is [i.e.], less than [<] 34.5 international units per milliliter [IU/mL]) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).

    Measured: At Week 8

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

    A TEAEs was defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsened in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability / incapacity, was a congenital anomaly / birth defect or was medically important due to other reasons than the above mentioned criteria.

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

  3. Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir

    The number of participants with TEAEs leading to maribavir study treatment discontinuation (including treatment interruption or withdrawal) were reported.

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

  4. Number of Participants With Clinically Meaningful Changes in Vital Signs

    Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any clinically meaningful change in vital signs which were deemed clinically significant by the investigator were reported.

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

  5. Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings

    Physical examination included assessments of the head, eyes, ears, nose, throat, neck, lymph nodes, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems. Any clinically meaningful change in physical examination which were deemed clinically significant by the investigator were reported.

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

  6. Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters

    Clinical laboratory parameters included evaluations of hematology, chemistry, urinalysis. Any clinically meaningful change in clinical laboratory parameters which were deemed clinically significant by the investigator were reported.

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

  7. Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)

    12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically meaningful by the investigator were reported.

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

  8. Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood

    Immunosuppressant drug concentration testing was solely for participants who received immunosuppressive therapy with tacrolimus, cyclosporine, or everolimus. The number of participants with an increased level of at least one immunosuppressant drug was reported.

    Measured: From first dose of study drug up to Week 8

  9. Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss

    New onset of acute or chronic GVHD assessed as TEAEs, and graft rejection, or graft loss assessed were reported.

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

Secondary outcomes (8)

  1. Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20

    The confirmed viremia clearance was defined as a plasma CMV DNA concentration below the LLOQ (i.e., <34.5 IU/mL) when assessed by the COBAS® 8800/COBAS® CMV Test, in two consecutive post-baseline samples, separated by at least 5 days. Percentage of participants who maintained combined CMV viremia clearance and CMV infection symptom control at Week 8 Through Weeks 12, 16 and 20 were reported.

    Measured: At Week 8 through Weeks 12, 16 and 20

  2. Time to First Confirmed CMV Viremia Clearance

    Time to first confirmed viremia clearance was defined as time from the start date of first dose of study treatment to the date of confirmed viremia clearance (event), or the date of last CMV DNA assessment on study before the initiation of alternative anti-CMV treatment (censored). The time to first confirmed CMV viremia clearance was calculated as date of first confirmed CMV viremia clearance - randomization date + 1). The date of first confirmed CMV viremia clearance was the date of first of two consecutive samples with plasma CMV DNA <LLOQ that meet the criteria of confirmed CMV viremia clearance.

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

  3. Percentage of Participants With Recurrence of Confirmed CMV Viremia During Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8 Who Required Additional Anti-CMV Treatment

    Recurrence of confirmed CMV viremia was defined as plasma CMV DNA concentration greater than or equal to (>= 34.5 IU/mL) LLOQ when assessed by the COBAS® 8800/COBAS®CMV Test in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance.

    Measured: From Week 9 up to Week 20

  4. Change From Baseline in Plasma CMV Viremia Load

    The change from baseline in plasma CMV viral load, i.e., plasma CMV DNA concentration was assessed and reported.

    Measured: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 14, 16, 18 and 20

  5. Percentage of Participants With Recurrence of CMV Viremia During Study Treatment and in the Follow-Up Period After the Participants Are Discontinued From Study Treatment and While On/Off Study Assigned Treatment

    Recurrence of CMV viremia was defined as plasma CMV DNA concentration >= lower limit of quantification (LLOQ, i.e. >=34.5 IU/mL) when assessed by COBAS® 8800/COBAS® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (<LLOQ, i.e. <34.5 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study. Study Treatment: The first stipulated 8 weeks treatment. Follow up period: period started after completion of stipulated 8 weeks treatment to Week 20. While on study assigned treatment: period over which participants received actual dosing regardless of stipulated 8 weeks completion (Week 8 or earlier). While off study assigned treatment: period after study treatment, regardless of stipulated 8 weeks completion (Week 8 or earlier up to Week 20).

    Measured: Study treatment: Week 0 to Week 8; Follow-up Period:Week 9 to Week 20; At Any time during study:Week 0 to Week 20; While on study assigned treatment: Week 0 to EOT(Week 8 or earlier); While off study assigned treatment: EOT (Week 8 or earlier) to Week 20

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

    Plasma samples were obtained and tested to identify mutations in the viral UL97 and UL54 genes confer resistance to maribavir. Percentage of participants with any mutations in the CMV genes conferring resistance to maribavir was reported.

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

  7. Percentage of Participants Who Achieved Confirmed CMV Viremia Clearance at Week 8 to be Less Than (<) 137 IU/mL

    The confirmed CMV viremia clearance at Week 8 was defined as plasma CMV DNA concentrations <137 IU/mL, in 2 consecutive post-baseline samples separated by at least 5 days, regardless of whether study treatment was discontinued before the end of the stipulated 8 weeks of therapy.

    Measured: At Week 8

  8. Minimum Observed Plasma Concentration (Cmin) of Maribavir

    Cmin (pre-dose) of maribavir was assessed.

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

Timeline

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

  1. First posted30 Nov 2021
  2. Study start18 Jan 2022
  3. Primary completion27 Jun 2023
  4. Study completion27 Jun 2023

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
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05137717
Sponsor's protocol ID
TAK-620-3001
Other IDs
jRCT2021210056
Status last verified
Jul 2024
First submitted
25 Nov 2021
Last updated
9 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
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.

Publications

  • Kanda Y, Takenaka K, Tanabe T, Omoto K, Kamimura K, Kudou K, Kaneko M. Efficacy and safety of maribavir in Japanese patients with post-transplant cytomegalovirus infections: a phase III study. Int J Hematol. 2026 Jun 12. doi: 10.1007/s12185-026-04220-3. Online ahead of print.

    PubMed 42283791

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 20 sites in Japan.

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 14 inclusion and 13 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 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 9 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8 (time frame: At Week 8). The study lists 9 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 NCT05137717, which also lists 1 linked publication.

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 9 Jul 2024.

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