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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2021210056 | Registry Identifier | jRCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maribavir | Experimental | Maribavir 400 milligrams (mg), tablets, orally twice a day (BID) for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maribavir | Drug | Maribavir tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Week 8 |
| 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. | From first dose of study drug up to Week 20 |
| 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. | From first dose of study drug up to Week 20 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria
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.
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):
Be able to swallow tablets.
Have life expectancy of >=8 weeks.
Weigh >=40 kg.
Exclusion Criteria
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ehime University Hospital | Tōon | Ehime | Japan | |||
| Kyushu University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42283791 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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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.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Japanese participants with cytomegalovirus (CMV) infection were enrolled to receive maribavir treatment in this study.
The study was conducted at 23 sites in Japan from 18 January 2022 to 27 June 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Maribavir | Participants received maribavir 400 milligrams (mg), oral tablet, twice a day (BID) for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full analysis set (FAS) included of all participants who had taken at least 1 dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Maribavir | Participants received maribavir 400 milligrams (mg), oral tablet, twice a day (BID) for up to 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | FAS included of all participants who had taken at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
From the 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maribavir | Participants received maribavir 400 mg, oral tablet, BID for up to 8 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 28, 2021 | Jun 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2023 | Jun 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C400401 | maribavir |
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| From first dose of study drug up to Week 20 |
| 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. | From first dose of study drug up to Week 20 |
| 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. | From first dose of study drug up to Week 20 |
| 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. | From first dose of study drug up to Week 20 |
| 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. | From first dose of study drug up to Week 8 |
| 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. | From first dose of study drug up to Week 20 |
| At Week 8 through Weeks 12, 16 and 20 |
| 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 \ | From first dose of study drug up to Week 20 |
| 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. | From Week 9 up to Week 20 |
| 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. | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 14, 16, 18 and 20 |
| 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 (\ | 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 |
| 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. | From first dose of study drug up to Week 20 |
| 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. | At Week 8 |
| Minimum Observed Plasma Concentration (Cmin) of Maribavir | Cmin (pre-dose) of maribavir was assessed. | At Weeks 1, 4, and 8: Pre-dose |
| Fukuoka |
| Fukuoka |
| Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | Japan |
| Sapporo City General Hospital | Sapporo | Hokkaido | Japan |
| Sapporo Hokuyu Hospital | Sapporo | Hokkaido | Japan |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | Japan |
| Imamura General Hospital | Kagoshima | Kagoshima-ken | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | Japan |
| Osaka University Hospital | Suita | Osaka | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | Japan |
| The Jikei University Hospital | Minato-ku | Tokyo | Japan |
| Toranomon Hospital | Minato-ku | Tokyo | Japan |
| Keio University Hospital | Shinjuku-ku | Tokyo | Japan |
| Yochomachi Clinic | Shinjuku-ku | Tokyo | Japan |
| Chiba University Hospital | Chiba | Japan |
| Fukushima Medical University Hospital | Fukushima | Japan |
| Kyoto University Hospital | Kyoto | Japan |
| Okayama University Hospital | Okayama | Japan |
| Osaka Metropolitan University Hospital | Osaka | Japan |
| Jichi Medical University Saitama Medical Center | Saitama | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimetres (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Body Mass Index (BMI) | BMI was calculated as weight (kg)/ (height [meter]) ^2. | Mean | Standard Deviation | kilograms per meter square (kg/m^2) |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 8 |
|
|
|
| Primary | 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. | Safety set included of all participants who had taken at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From first dose of study drug up to Week 20 |
|
|
|
| Secondary | 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. | FAS included of all participants who had taken at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 through Weeks 12, 16 and 20 |
|
|
|
| Secondary | 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 \ | FAS included of all participants who had taken at least 1 dose of study treatment. | Posted | Median | 95% Confidence Interval | days | From first dose of study drug up to Week 20 |
|
|
|
| Secondary | 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. | FAS included of all participants who had taken at least 1 dose of study treatment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | From Week 9 up to Week 20 |
|
|
|
| Secondary | 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. | FAS included of all participants who had taken at least 1 dose of study treatment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified timepoints. | Posted | Mean | Standard Deviation | IU/mL | Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,12, 14, 16, 18 and 20 |
|
|
|
| Secondary | 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 (\ | FAS included of all participants who had taken at least 1 dose of study treatment. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | 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 |
|
|
|
| Secondary | 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. | FAS included of all participants who had taken at least 1 dose of study treatment. | Posted | Number | percentage of participants | From first dose of study drug up to Week 20 |
|
|
|
| Secondary | 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. | FAS included of all participants who had taken at least 1 dose of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 8 |
|
|
|
| Secondary | Minimum Observed Plasma Concentration (Cmin) of Maribavir | Cmin (pre-dose) of maribavir was assessed. | Pharmacokinetic set included of all participants in the safety set who had plasma sample drawn and tested for maribavir concentrations. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable for the specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | At Weeks 1, 4, and 8: Pre-dose |
|
|
|
| 2 |
| 41 |
| 13 |
| 41 |
| 26 |
| 41 |
| COVID-19 | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 26 | Systematic Assessment |
|
| Chronic myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26 | Systematic Assessment |
|
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
|
| Graft versus host disease | Immune system disorders | MedDRA 26 | Systematic Assessment |
|
| Graft versus host disease in gastrointestinal tract | Immune system disorders | MedDRA 26 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 26 | Systematic Assessment |
|
| Laryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26 | Systematic Assessment |
|
| Pneumonia legionella | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 26 | Systematic Assessment |
|
| Transplantation complication | Injury, poisoning and procedural complications | MedDRA 26 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 26 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 26 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 26 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 26 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 26 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 26 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 26 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 26 | Systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 26 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Measurements |
|---|---|
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| At Week 20 |
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| Change at Week 3 |
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| Change at Week 4 |
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| Change at Week 5 |
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| Change at Week 6 |
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| Change at Week 7 |
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| Change at Week 8 |
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| Change at Week 9 |
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| Change at Week 10 |
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| Change at Week 11 |
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| Change at Week 12 |
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| Change at Week 14 |
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| Change at Week 16 |
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| Change at Week 18 |
|
|
| Change at Week 20 |
|
|
| Title | Measurements |
|---|---|
|
| While on Study Assigned Treatment (Week 0 to End of Treatment [EOT] [Week 8 or earlier]) |
|
| While off Study Assigned Treatment (EOT [Week 8 or earlier] to Week 20) |
|
|
| Week 8: Pre-dose |
|
|