Trial · NCT05137717

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

NCT05137717, Phase 3, Completed, Takeda; results first posted 2024-07-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection. Trials, record NCT05137717. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05137717

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection
NCT number: NCT05137717
Status: Completed
Phases: Phase 3
Enrollment: 41 participants, actual
Lead sponsor: Takeda
Conditions: Cytomegalovirus (CMV)
Interventions: Maribavir
First posted: 2021-11-30
Last updated: 2024-07-09
Results first posted: 2024-07-09

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8	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).
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	From first dose of study drug up to Week 20	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.
Primary	Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir	From first dose of study drug up to Week 20	The number of participants with TEAEs leading to maribavir study treatment discontinuation (including treatment interruption or withdrawal) were reported.
Primary	Number of Participants With Clinically Meaningful Changes in Vital Signs	From first dose of study drug up to Week 20	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.
Primary	Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings	From first dose of study drug up to Week 20	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.
Primary	Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters	From first dose of study drug up to Week 20	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.
Primary	Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)	From first dose of study drug up to Week 20	12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically meaningful by the investigator were reported.
Primary	Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood	From first dose of study drug up to Week 8	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.
Primary	Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss	From first dose of study drug up to Week 20	New onset of acute or chronic GVHD assessed as TEAEs, and graft rejection, or graft loss assessed were reported.
Secondary	Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20	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.

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8	At Week 8	FAS included of all participants who had taken at least 1 dose of study treatment.	percentage of participants	NUMBER
PRIMARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Meaningful Changes in Vital Signs	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood	From first dose of study drug up to Week 8	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss	From first dose of study drug up to Week 20	Safety set included of all participants who had taken at least 1 dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control at Week 8 Through Weeks 12, 16 and 20	At Week 8 through Weeks 12, 16 and 20	FAS included of all participants who had taken at least 1 dose of study treatment.	percentage of participants	NUMBER

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group43

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percentage of Participants Who Achieved Confirmed Clearance of Plasma CMV Deoxyribose Nucleic Acid (DNA) at Week 8	Maribavir		68.3	95% Confidence Interval 51.9 to 81.9	percentage of participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Maribavir	Participants with TEAEs	39		Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	Maribavir	Participants with Serious TEAEs	13		Participants
Number of Participants With TEAEs Leading to Treatment Discontinuation With Maribavir	Maribavir		9		Participants
Number of Participants With Clinically Meaningful Changes in Vital Signs	Maribavir		0		Participants
Number of Participants With Clinically Meaningful Abnormalities in Physical Examination Findings	Maribavir		0		Participants
Number of Participants With Clinically Meaningful Abnormalities in Clinical Laboratory Parameters	Maribavir		0		Participants
Number of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs)	Maribavir		0		Participants
Number of Participants With Events of Immunosuppressant Drug Level Increased in Blood	Maribavir		1		Participants
Number of Participants With TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss	Maribavir	TEAEs of Acute or Chronic GVHD	2		Participants

1 to 10 of 43Source ClinicalTrials.gov

See all 43 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Maribavir	41
Overall Study	COMPLETED	Maribavir	33
Overall Study	NOT COMPLETED	Maribavir	8

Source ClinicalTrials.gov

Adverse events33

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Maribavir	7	41
other	Decreased appetite	Metabolism and nutrition disorders	Maribavir	4	41
other	Dysgeusia	Nervous system disorders	Maribavir	3	41
other	Generalised oedema	General disorders	Maribavir	4	41
other	Headache	Nervous system disorders	Maribavir	6	41
other	Hypertension	Vascular disorders	Maribavir	3	41
other	Insomnia	Psychiatric disorders	Maribavir	4	41
other	Nausea	Gastrointestinal disorders	Maribavir	10	41
other	Neutrophil count decreased	Investigations	Maribavir	3	41
other	Oedema peripheral	General disorders	Maribavir	3	41

1 to 10 of 33Source ClinicalTrials.gov

See all 33 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Maribavir	2	41
Total, other adverse events	Maribavir	26	41
Total, serious adverse events	Maribavir	13	41

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42283791	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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