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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004726-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir.
Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it.
After treatment, each participant will be followed up for up to 12 weeks.
Participants will visit their study clinic up to 18 times during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valganciclovir 900 mg BID | Active Comparator | Participants received 900 milligrams (mg) of valganciclovir along with a placebo matched to maribavir, twice daily (BID) orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study. |
|
| Maribavir 400 mg BID | Experimental | Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maribavir | Drug | Participants will receive 400 mg of maribavir BID orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 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). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this key secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). CMV Infection Symptom Control is defined as no new clinical findings of CMV tissue invasive disease. Maintenance of Treatment Effect is defined as maintaining confirmed CMV viremia clearance and CMV infection symptom control through Week 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Developing Resistance | Resistance was defined as the presence of any CMV resistance-associated amino acid substitution that has been documented (or suspected) to be associated with reduced susceptibility to conventional anti-CMV therapies (ganciclovir/valganciclovir, foscarnet, and cidofovir) or maribavir. Genotypic resistance analyses were restricted to sequence variants that were known or suspected to be associated with resistance to conventional anti-CMV therapies or maribavir as of January 21, 2022. A participant was categorized as having developed resistance if the central lab genotyping results indicated the presence of one or more treatment-emergent resistance mutations. |
Inclusion Criteria:
Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participants before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 January 2021, Q11).
Be greater than or equal to (>=) 16 years of age at the time of consent.
Be a recipient of hematopoietic stem cell transplant.
Have a documented asymptomatic CMV infection, with a screening value of CMV DNA >=1365 International Units per millilitre (IU/mL) to less than or equal to (<=) 273000 IU/mL in whole blood or >=455 IU/mL to <=91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Participants with CMV DNA less than (<) 910 and >=455 IU/mL in plasma or <2730 and >=1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible:
Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.
Per investigator's judgment, be eligible for treatment with valganciclovir.
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):
Have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment.
Be able to swallow tablets.
Have life expectancy of >=8 weeks.
Weigh >=40 kilograms (kg).
Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.
Exclusion Criteria:
Note: Participants who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| UCLA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39302855 | Derived | Chou S, Winston DJ, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Gu J, Pocock G, Papanicolaou GA. Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection. J Infect Dis. 2025 Mar 17;231(3):e470-e477. doi: 10.1093/infdis/jiae469. | |
| 38036487 |
| 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.
Participants who were hematopoietic stem cell transplant (HSCT) recipients with a diagnosis of asymptomatic cytomegalovirus (CMV) infection were enrolled then randomized in a 1:1 ratio to receive either maribavir or valganciclovir (along with placebo matched to comparator) in each arm in a double-blind, double-dummy fashion.
Participants were randomized at 97 sites in United States,Spain,France,Germany,United Kingdom,Belgium,China,Italy,Israel,Australia,Canada,Singapore,Croatia, Czech Republic,Greece,Hungary,Korea,New Zealand,Poland,Russia,Switzerland, and Turkey from 14 April 2017(first participant first visit) to 01 July 2022(last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | Valganciclovir 900 mg BID | Participants received 900 milligrams (mg) of valganciclovir along with a placebo matched to maribavir, twice daily (BID) orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2021 | Dec 14, 2022 |
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| Valganciclovir |
| Drug |
Participants will receive valganciclovir tablets orally. |
|
| Placebo | Other | Participants will receive placebo tablets matched to either maribavir or valganciclovir. |
|
| Week 8 up to Week 16 |
| Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. Participants who discontinued treatment early were non-responders for this endpoint. | Week 8 |
| Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. | Week 8 through Weeks 12, 16 and 20 |
| Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether the 8-week study-assigned treatment was completed or discontinued early) and had no symptoms of tissue invasive CMV disease at Week 8, Week 8 through Week 12, and Week 8 through Week 20, respectively. | Week 8 through Weeks 12 and 20 |
| Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) lower limit of quantification (LLOQ, i.e. >=137 International units per milliliter [IU/mL]) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Up to Week 8 |
| Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | From Week 9 up to Week 20 |
| Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Up to Week 20 |
| Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Baseline up to Week 20 |
| Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment | Grade 3 and grade 4 neutropenia are defined as absolute neutrophil count (ANC) <1000 per cubic millimeter (/mm^3) and ANC <500/mm^3 respectively. Incidence of Grade 3 or 4 neutropenia represents the percentage of participants with Grade <3 (or missing) neutropenia at baseline, but Grade 3 or 4 while on study treatment. Incidence of Grade 4 neutropenia represents the number of participants with Grade <4 (or missing) neutropenia at baseline, but Grade 4 while on study treatment. | From start of study drug to end of study drug + 1 day (up to approximately Week 8) |
| Number of Participants With Treatment-Emergent Adverse Events During the On-Treatment Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE that has a start date on or after the first dose of study treatment, or that has a start date before the date of first dose of study treatment but increases in severity after the first dose of study treatment, will be considered a treatment-emergent AE (TEAE). | From the start of the study treatment to 7 days after the last dose of study treatment (up to approximately Week 9) |
| Predose Concentration (Cmin) of Maribavir | The primary plasma maribavir concentration dataset (primary concentration dataset) includes all plasma maribavir concentrations. Missing PK sampling times are imputed according to the sparse sampling schedule in primary concentration dataset. | Weeks 1, 4, and 8: pre-morning dose |
| Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
| Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
| Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
| Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
| Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
| From start of study drug up to end of the study (up to Week 20) |
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University | Stanford | California | 94305 | United States |
| Colorado Blood Cancer Institute - PPDS | Denver | Colorado | 80218 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Harper University Hospital | Detroit | Michigan | 48201 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Mayo Clinic - PIN | Rochester | Minnesota | 59905 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Joan and sandford I. Weill Medical College of Cornell University Clinic | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| TriStar Centennial Medical Center | Nashville | Tennessee | 37203-1624 | United States |
| Saint Davids South Austin Medical Center | Austin | Texas | 78704 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| VA Puget Sound Health Care System - NAVREF - PPDS | Seattle | Washington | 98108 | United States |
| The Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | United States |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Medizinische Universitat Wien (Medical University of Vienna) | Vienna | State of Vienna | Austria |
| Elisabethinen Hospital Linz | Linz | 4020 | Austria |
| UZ Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Institute Jules Bordet | Brussels | Brussels Capital | 1000 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | 1200 | Belgium |
| Universitair Ziekenhuis Brussel - PIN | Jette | Brussels Capital | 1090 | Belgium |
| University Hospital Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| UZ Leuven | Leuven | Vlaams Brabant | 3000 | Belgium |
| AZ Sint-Jan AV | Bruges | West-Vlaanderen | 8000 | Belgium |
| CHU de Liège | Liège | 4000 | Belgium |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | L8N 3Z5 | Canada |
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Nanfang Hospital Southern Medical University | Guangzhou | Guangdong | 510515 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Xiangya Hospital Central South University | Changsha | 410008 | China |
| Guangzhou First People's Hospital | Guangzhou | 510180 | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou Zhejiang | 310003 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| University Hospital Center Zagreb | Zagreb | 10000 | Croatia |
| Fakultni nemocnice v Motole | Prague | Praha, Hlavní Mesto | 150 00 | Czechia |
| Ustav hematologie a krevni transfuze | Prague | 128 20 | Czechia |
| Institut de Cancérologie Strasbourg Europe | Strasbourg | Bas-Rhin | 67033 | France |
| Hopital de Hautepierre | Strasbourg | Bas-Rhin | 67098 | France |
| CHU de Bordeaux | Pessac | Gironde | 33604 | France |
| Hôpital Universitaire Dupuytren | Limoges | Haute-Vienne | 87042 | France |
| CHU de GRENOBLE | Grenoble | Isère | 38043 | France |
| Hôtel Dieu | Nantes | Loire-Atlantique | 44093 | France |
| CHU Angers | Angers | Maine-et-Loire | 49933 | France |
| Hopital Henri Mondor | Créteil | Val-de-Marne | 94010 | France |
| Hopital Jean Minjoz | Besnçon | 25030 | France |
| Institut Paoli Calmettes | Nice | 7120 | France |
| Hôpital Saint Antoine | Paris | 75012 | France |
| Hôpital Saint Louis | Paris | 75475 | France |
| EDOG - Institut Claudius Regaud - PPDS | Toulouse | 31059 | France |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | Rhineland-Palatinate | 55131 | Germany |
| Universität des Saarlandes | Homburg | Saarland | 66424 | Germany |
| Universitatsklinikum Leipzig | Leipzig | Saxony | 04103 | Germany |
| Universitätsklinikum Augsburg | Augsburg | 86156 | Germany |
| Helios Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Martin Luther Universitat Halle Wittenberg | Halle | 6120 | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | 20251 | Germany |
| Universitätsklinik Rostock | Rostock | Germany |
| Robert Bosch Krankenhaus | Stuttgart | 70376 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Attikon University General Hospital | Athens | Attica | 124 64 | Greece |
| Georgios Papanikolaou General Hospital of Thessaloniki | Thessaloniki | 57010 | Greece |
| Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet | Budapest | 1097 | Hungary |
| Sheba Medical Center - PPDS | Ramat Gan | Central District | 5262000 | Israel |
| Hadassah Medical Center - PPDS | Jerusalem | Jerusalem | 90000 | Israel |
| Rambam Medical Center - PPDS | Haifa | 31999 | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Tel Aviv | 64239 | Israel |
| Ospedale Dell'Angelo | Brescia | Lombardy | 30174 | Italy |
| Ospedale Infantile Regina Margherita - INCIPIT - PIN | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliera Universitaria Integrata Di Verona | Verona | Veneto | 37134 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50134 | Italy |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | 20122 | Italy |
| Fondazione Policlinico Universitario A Gemelli | Roma | 00168 | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Auckland City Hospital | Grafton | Auckland | 1023 | New Zealand |
| Canterbury Health Laboratories | Christchurch | South Island | 8011 | New Zealand |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Lower Silesian Voivodeship | 50-367 | Poland |
| MTZ Clinical Research Sp z o o - PRATIA - PPDS | Warsaw | Masovian Voivodeship | 02-106 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| First St. Petersburg State Medical University n.a. I.P Pavlov | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| Regional Oncology Center | Irkutsk | 664035 | Russia |
| Kirov Research Institute of Haematology and Blood Transfusion | Kirov | 610027 | Russia |
| National University Hospital | Singapore | 119228 | Singapore |
| Singapore General Hospital (SGH) | Singapore | 169608 | Singapore |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Complejo Asistencial Universitario de Salamanca - H. Clinico | Salamanca | Castille and León | 37007 | Spain |
| Hospital Universitario Vall d'Hebrón - PPDS | Barcelona | 08035 | Spain |
| ICO l'Hospitalet Hospital Duran i Reynals | Barcelona | 08908- | Spain |
| C.H. Regional Reina Sofia - PPDS | Córdoba | 14004 | Spain |
| Hospital Universitario Virgen de Las Nieves | Granada | 18014 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | 28222 | Spain |
| Hospital Regional Universitario de Malaga - Hospital General | Málaga | 29010 | Spain |
| Hospital Universitario de Donostia | San Sebastian Gipuzkoa | 20014 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Baskent University Medical Faculty Adana Practice and Research Center | Adana | 1250 | Turkey (Türkiye) |
| Ankara University Medica Faculty Hematology Department Clinical Research Area PPDS | Ankara | 06590 | Turkey (Türkiye) |
| Birmingham Heartlands Hospital | West Midlands | Birmingham | B9 5SS | United Kingdom |
| Hammersmith Hospital | London | London, City of | W12 0HS | United Kingdom |
| University College London | London | London, City of | WC1E 6BT | United Kingdom |
| St George's Hospital | Tooting | London | SW17 0QT | United Kingdom |
| Clatterbridge Cancer Centre Liverpool | Liverpool | Merseyside | L7 8XP | United Kingdom |
| The Christie NHS Foundation Trust - PPDS | Manchester | M20 4BX | United Kingdom |
| Southampton University Hospitals NHS Trust | Southampton | SO16 6YD | United Kingdom |
| Papanicolaou GA, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Fournier M, Murray RA, Wu J, Winston DJ; AURORA Trial Investigators. Treatment for First Cytomegalovirus Infection Post-Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir. Clin Infect Dis. 2024 Mar 20;78(3):562-572. doi: 10.1093/cid/ciad709. |
| 37899366 | Derived | Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30. |
| FG001 |
| Maribavir 400 mg BID |
Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks. |
| Treated Participants | Treated participants (full analysis set) included the participants from the randomized set who took at least one dose of assigned study drug and were analyzed for efficacy and safety evaluations. |
|
| Participants Received 8 Weeks Treatment | Participants who received 8 weeks of treatment include the participants who completed study drug treatment. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Randomized set included all participants in the enrolled set for whom a randomization number had been assigned.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Valganciclovir 900 mg BID | Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study. |
| BG001 | Maribavir 400 mg BID | Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Number analyzed is the number of participants with data available for analysis for height. | Mean | Standard Deviation | cm |
| ||||||||||||||
| Weight | Number analyzed is the number of participants with data available for analysis for weight. | Mean | Standard Deviation | kg |
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| Body Mass Index (BMI) | BMI = Body Mass Index. It is computed by [weight (kg) / height (cm)^2] x 10,000. | Number analyzed is the number of participants with data available for analysis for BMI. | Mean | Standard Deviation | kg/m^2 |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 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). | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this key secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). CMV Infection Symptom Control is defined as no new clinical findings of CMV tissue invasive disease. Maintenance of Treatment Effect is defined as maintaining confirmed CMV viremia clearance and CMV infection symptom control through Week 16. | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Posted | Count of Participants | Participants | Week 8 up to Week 16 |
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| Secondary | Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. Participants who discontinued treatment early were non-responders for this endpoint. | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Posted | Count of Participants | Participants | Week 8 |
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| Secondary | Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Posted | Count of Participants | Participants | Week 8 through Weeks 12, 16 and 20 |
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| Secondary | Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. <137 International units per milliliter [IU/mL]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether the 8-week study-assigned treatment was completed or discontinued early) and had no symptoms of tissue invasive CMV disease at Week 8, Week 8 through Week 12, and Week 8 through Week 20, respectively. | Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment. | Posted | Count of Participants | Participants | Week 8 through Weeks 12 and 20 |
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| Secondary | Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) lower limit of quantification (LLOQ, i.e. >=137 International units per milliliter [IU/mL]) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Posted | Count of Participants | Participants | Up to Week 8 |
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| Secondary | Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Posted | Count of Participants | Participants | From Week 9 up to Week 20 |
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| Secondary | Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Posted | Count of Participants | Participants | Up to Week 20 |
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| Secondary | Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment | Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\ | Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance. | Posted | Count of Participants | Participants | Baseline up to Week 20 |
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| Secondary | Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment | Grade 3 and grade 4 neutropenia are defined as absolute neutrophil count (ANC) <1000 per cubic millimeter (/mm^3) and ANC <500/mm^3 respectively. Incidence of Grade 3 or 4 neutropenia represents the percentage of participants with Grade <3 (or missing) neutropenia at baseline, but Grade 3 or 4 while on study treatment. Incidence of Grade 4 neutropenia represents the number of participants with Grade <4 (or missing) neutropenia at baseline, but Grade 4 while on study treatment. | Safety set included all participants who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From start of study drug to end of study drug + 1 day (up to approximately Week 8) |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events During the On-Treatment Period | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE that has a start date on or after the first dose of study treatment, or that has a start date before the date of first dose of study treatment but increases in severity after the first dose of study treatment, will be considered a treatment-emergent AE (TEAE). | Safety set included all participants who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From the start of the study treatment to 7 days after the last dose of study treatment (up to approximately Week 9) |
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| Secondary | Predose Concentration (Cmin) of Maribavir | The primary plasma maribavir concentration dataset (primary concentration dataset) includes all plasma maribavir concentrations. Missing PK sampling times are imputed according to the sparse sampling schedule in primary concentration dataset. | Pharmacokinetic (PK) Set included all participants in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants available for analyses at the given timepoint. | Posted | Mean | Standard Deviation | micrograms per milliliter (µg/mL) | Weeks 1, 4, and 8: pre-morning dose |
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| Secondary | Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only | An adolescent PK set consisted of all participants of ≥16 to <18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. | Posted | Mean | Full Range | hours (h)*μg/mL | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only | An adolescent PK set consisted of all participants of ≥16 to <18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. | Posted | Mean | Full Range | µg/mL | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
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| Secondary | Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only | An adolescent PK set consisted of all participants of ≥16 to <18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. | Posted | Median | Full Range | hours (h) | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
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| Secondary | Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only | An adolescent PK set consisted of all participants of ≥16 to <18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. | Posted | Mean | Full Range | liters per hour (L/h) | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only | An adolescent PK set consisted of all participants of ≥16 to <18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. | Posted | Mean | Full Range | liters (L) | Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1 |
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| Other Pre-specified | Number of Participants Developing Resistance | Resistance was defined as the presence of any CMV resistance-associated amino acid substitution that has been documented (or suspected) to be associated with reduced susceptibility to conventional anti-CMV therapies (ganciclovir/valganciclovir, foscarnet, and cidofovir) or maribavir. Genotypic resistance analyses were restricted to sequence variants that were known or suspected to be associated with resistance to conventional anti-CMV therapies or maribavir as of January 21, 2022. A participant was categorized as having developed resistance if the central lab genotyping results indicated the presence of one or more treatment-emergent resistance mutations. | Safety set included all participants who took at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From start of study drug up to end of the study (up to Week 20) |
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All-cause mortality: From start of study drug up to end of the study (up to Week 20); Serious and Other Adverse Events: From the start of the study drug to 7 days after the last dose of study treatment (up to approximately Week 9)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Valganciclovir 900 mg BID | Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study. | 29 | 277 | 95 | 274 | 256 | 274 |
| EG001 | Maribavir 400 mg BID | Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks. | 37 | 276 | 88 | 273 | 245 | 273 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute graft versus host disease in intestine | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute graft versus host disease in skin | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute graft versus host disease oral | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute lymphocytic leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Acute polyneuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Autoimmune haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| B precursor type acute leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic graft versus host disease | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic graft versus host disease in eye | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic graft versus host disease in intestine | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis haemorrhagic | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus gastritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus gastrointestinal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus oesophagitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Disseminated toxoplasmosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysbiosis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Epstein-Barr viraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Epstein-Barr virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Eye infection toxoplasmal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Food intolerance | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis astroviral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster meningoencephalitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Herpes zoster reactivation | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Leukaemic infiltration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Limbic encephalitis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection fungal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neurosensory hypoacusis | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia parainfluenzae viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Product use issue | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Streptococcal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Toxoplasmosis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Transformation to acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Transplant rejection | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Warm type haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute graft versus host disease in skin | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 23.0 | 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 | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2022 | Dec 14, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C400401 | maribavir |
| D000077562 | Valganciclovir |
| ID | Term |
|---|---|
| D015774 | Ganciclovir |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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| China |
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| Korea, South |
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| New Zealand |
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| Belgium |
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| Switzerland |
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| Czech Republic |
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| Germany |
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| Croatia |
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| Israel |
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| Turkey |
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| United States |
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Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks. |
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Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.
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