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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004279-15 | EudraCT Number | ||
| jRCT2031230753 | Registry Identifier | jRCT | |
| 2023-508988-73-00 | EU Trial (CTIS) Number | EU Trial Number |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of maribavir using a 200 milligrams (mg) tablet formulation or powder for oral suspension.
The participants will be treated with maribavir for 8 weeks.
Participants need to visit their doctor during 12-week follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Maribavir 400, 200 or 100 mg | Experimental | Participants with greater than or equal to (>=) 12 to less than (<) 18 years of age will receive maribavir 400 milligrams (mg) (2*200 mg tablets or powder for oral suspension) twice daily (BID) based on body weight >= 25 kilogram (kg); or 200 mg tablet or powder for oral suspension BID based on body weight 14 to < 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to < 14 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8). |
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| Cohort 2: Maribavir 400, 200 or 100 mg | Experimental | Participants with >= 6 to < 12 years of age will receive maribavir 400 mg (2*200 mg tablets or powder for oral suspension) BID based on body weight >= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to < 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to < 14 kg orally for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8). |
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| Cohort 3: Maribavir 400, 200, 100 or 50 mg | Experimental | Participants with 0 to < 6 years of age will receive maribavir 400 mg (2*200 mg tablets or powder for oral suspension) BID based on body weight >= 25 kg; or 200 mg tablet or powder for oral suspension BID based on body weight 14 to < 25 kg; or 100 mg powder for oral suspension BID based on body weight 10 to < 14 kg; or 50 mg powder for oral suspension BID based on body weight 7 to < 10 kg; or 50 mg powder for oral suspension once daily (QD) based on body weight 5 to <7 kg for up to 8 weeks treatment period (Day 1/Week 0 to Day 56/Week 8). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maribavir | Drug | Participants will receive maribavir. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Maribavir | Cmax of maribavir will be evaluated. | Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Time to Maximum Observed Concentration (Tmax) of Maribavir | Tmax of maribavir will be evaluated. | Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Minimum Plasma Concentration (Cmin) of Maribavir | Cmin of maribavir will be evaluated. | Pre-dose; (0.5, 1.5, 3, 4, 6, and 8 hours post-dose) on Day 7 (Week 1); Pre-dose on Day 28 (Week 4); Pre-dose; (2 to 4 hours post-dose) on Day 56 (Week 8) |
| Area Under the Plasma Concentration-Time Curve Over the 1 Dosing Interval of 12 Hours at Steady State (AUC0-tau) of Maribavir | AUC0-tau of maribavir will be evaluated. | Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Half-Life (t1/2) of Maribavir | t1/2 of maribavir will be evaluated. | Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Terminal Elimination Rate Constant (lambdaz) of Maribavir | Lambdaz of maribavir will be evaluated. | Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Apparent Volume of Distribution (Vz/F) of Maribavir | Vz/F of maribavir will be evaluated. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed CMV viremia Clearance at Week 8 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower limit of quantification (LLOQ) at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days at Week 8 regardless of the length of study treatment. Percentage of participants with confirmed CMV viremia clearance at Week 8 will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
Previously approved agents under investigation for additional indications are not exclusionary.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Takeda Contact | Contact | +1-877-825-3327 | medinfoUS@takeda.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Health - Wilmington - PIN | Recruiting | Wilmington | Delaware | 19803-3607 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38447094 | Derived | Fisher JE, Mulieri K, Finch E, Ericson JE. Use of Maribavir for Multidrug Resistant Cytomegaloviremia in a Pediatric Oncology Patient. J Pediatr Hematol Oncol. 2024 Apr 1;46(3):e244-e247. doi: 10.1097/MPH.0000000000002841. Epub 2024 Mar 1. |
| Label | URL |
|---|---|
| Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed. | 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.
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Three dosing cohorts based on participant's age.
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| Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Apparent Oral Clearance (CL/F) of Maribavir | CL/F of maribavir will be evaluated. | Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1) |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily be considered related to investigational product. SAE is any untoward medical occurrence (whether considered related to investigational product or not) that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, or is an important medical event. | From start of study drug administration up to follow-up (Week 20) |
| At Week 8 |
| Percentage of Participants who Achieve Maintenance of Confirmed CMV Viremia Clearance and Symptom Control at Week 8 Through Weeks 12, 16 and 20 | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower LLOQ at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days regardless of the length of study treatment. CMV infection symptom control is defined as resolution or improvement of tissue invasive disease or CMV syndrome for symptomatic participants at baseline, or no new symptoms for asymptomatic participants at baseline. Percentage of participants who achieve maintenance of confirmed CMV viremia clearance and symptom control at Week 8 through Weeks 12, 16 and 20 will be reported. | At Week 8 through Weeks 12, 16, and 20 |
| Percentage of Participants With Confirmed Recurrence of CMV Viremia on Study Treatment and Off Study Treatment | Confirmed recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (>=) LLOQ when assessed in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with confirmed recurrence of viremia on study treatment and off study treatment will be reported. | Up to Week 20 |
| Time to First Confirmed Viremia Clearance | Confirmed CMV viremia clearance is defined as plasma CMV DNA concentration below the lower LLOQ when assessed at a central specialty laboratory, in 2 consecutive postbaseline samples, separated by at least 5 days. Time to first confirmed viremia clearance at any time during the study will be summarized using the Kaplan-Meier method. | Up to Week 20 |
| Percentage of Participants With Confirmed Recurrence of CMV Viremia Treated With Alternative Anti-CMV Treatment During 12-Week Follow-up Period in Participants With Confirmed Viremia Clearance at Week 8 | Confirmed recurrence of CMV viremia is defined as plasma CMV DNA concentration >= LLOQ when assessed in 2 consecutive plasma samples at least 5 days apart, after achieving confirmed viremia clearance. Percentage of participants with confirmed recurrence of CMV viremia treated with alternative anti-CMV treatment in the 12-Week follow-up period in participants with confirmed viremia clearance at Week 8 will be reported. | From Week 8 through Week 20 |
| Change From Baseline in Log10 Plasma CMV Deoxyribonucleic Acid (DNA) Load | Change from baseline in log10 plasma CMV DNA on study after receiving study treatment by study week will be reported. | Baseline up to Week 20 |
| Number of Participants who Develop CMV Resistance to Maribavir | CMV DNA genotyping will be performed for the UL97, UL54, UL56, and UL27 genes known to confer resistance to conventional anti-CMV therapies or Maribavir. Number of participants who developed post-baseline CMV resistance to maribavir up to Week 12 will be reported. | Up to Week 12 |
| Summary Scores for Palatability Assessment of Maribavir | Palatability (taste, feel, smell, ease of swallowing and after-taste) is being measured using a 5-point facial hedonic scale correlated with a 100-point linear visual analogue scale (VAS) ranges from 0: very bad to 100: very good. Scores will be summarized descriptively at Weeks 1, 4 and 8. | At Weeks 1, 4, and 8 |
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| Ann and Robert H Lurie Childrens Hospital of Chicago - PIN | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Nebraska Medical Center -985400 Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68114-4113 | United States |
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| Cincinnati Children's Hospital Medical Center - PIN | Recruiting | Cincinnati | Ohio | 45229-3026 | United States |
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| Cook Children's Health Care System | Recruiting | Fort Worth | Texas | 76104-2733 | United States |
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| University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd | Recruiting | Houston | Texas | 77030-4000 | United States |
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| Texas Children's Hospital - Wallace Tower - PIN | Recruiting | Houston | Texas | 77030 | United States |
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| Minderoo Children's Comprehensive Cancer Centre | Recruiting | Randwick | New South Wales | 2031 | Australia |
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| Queensland Children's Hospital | Recruiting | Woollangabba | Queensland | 4101 | Australia |
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| Royal Children's Hospital Melbourne - PIN | Recruiting | Parkville | Victoria | 3052 | Australia |
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| Perth Children's Hospital | Recruiting | Nedlands | Western Australia | 6009 | Australia |
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| Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) | Recruiting | Brussels | Brussels Capital | 1020 | Belgium |
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| Cliniques Universitaires Saint-Luc | Recruiting | Woluwe-Saint-Lambert | Brussels Capital | 1200 | Belgium |
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| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
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| Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Recruiting | Porto Alegre | Rio Grande do Sul | 05403-000 | Brazil |
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| Irmandade Da Santa Casa de Misericordia de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
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| Hospital de Clinicas de Porto Alegre (HCPA) - PPDS | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
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| Hospital Do Rim E Hipertensão | Recruiting | São Paulo | 04038-002 | Brazil |
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| Capital Center For Children's Healthy, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| Beijing Children's Hospital, Capital Medical University - PIN | Recruiting | Beijing | Beijing Municipality | 100045 | China |
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| The First Affiliated Hospital, Sun Yat-sen University - Main | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Shenzhen Children's Hospital | Recruiting | Shenzhen | Guangdong | 518038 | China |
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| Shanghai Children's Medical Center - Zhangjiang Campus | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| CHU de Rennes - Hôpital Pontchaillou | Recruiting | Rennes | Ille-et-Vilaine | 35200 | France |
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| CHU de Grenoble Alpes - Hôpital Michallon | Recruiting | La Tronche | Isère | 38700 | France |
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| CHRU Nantes | Recruiting | Nantes | Loire-Atlantique | 44000 | France |
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| Hopital Necker | Recruiting | Paris | 75015 | France |
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| Universitätsklinikum Würzburg | Recruiting | Würzburg | Bavaria | 97080 | Germany |
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| Universitätsklinikum Münster | Recruiting | Münster | North Rhine-Westphalia | 48149 | Germany |
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| Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101 | Recruiting | Jena | Thuringia | 07745 | Germany |
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| Universitätsklinikum Hamburg Eppendorf | Recruiting | Hamburg | 20246 | Germany |
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| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
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| The Chaim Sheba Medical Center - PPDS | Recruiting | Ramat Gan | Tel Aviv | 52394 | Israel |
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| Tel Aviv Sourasky Medical Center Ichilov - PPDS | Recruiting | Tel Aviv | Tel Aviv | 64239 | Israel |
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| Rambam Health Care Campus - PPDS | Recruiting | Haifa | 31096 | Israel |
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| Hadassah Medical Center- Ein Kerem - PPDS | Recruiting | Petah Tikva | 4920235 | Israel |
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| Saitama Prefectural Children's Medical Center | Recruiting | Saitama-Shi Chuo-Ku | Saitama | 330-8777 | Japan |
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| Shizuoka Children's Hospital | Recruiting | Aoi-ku | Shizuoka | 420-8660 | Japan |
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| National Center for Child Health and Development | Recruiting | Setagaya-Ku | Tokyo | 157-8535 | Japan |
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| Hyogo Prefectural Kobe Children's Hospital | Recruiting | Chiba | 650-0047 | Japan |
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| Osaka Women's and Children's Hospital | Recruiting | Izumi-Shi | Ôsaka | 594-1101 | Japan |
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| Hospital Sant Joan de Deu - PIN | Recruiting | Espluges de Llobregat | Barcelona | 08950 | Spain |
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| Hospital Universitario La Paz - PPDS | Recruiting | Horcajo de la Sierra | Madrid | 28755 | Spain |
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| Hospital Regional Universitario de Malaga - Hospital Materno-Infantil | Recruiting | Málaga | Málaga | 29011 | Spain |
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| Hospital Universitario Vall d´Hebron- PPDS | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Infantil Universitario Niño Jesus - PIN | Recruiting | Madrid | 28009 | Spain |
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| King's College Hospital | Recruiting | London | Lambeth | SE5 9RS | United Kingdom |
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| Royal Manchester Children's Hospital - PIN | Recruiting | Manchester | Lancashire | M13 9WL | United Kingdom |
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| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
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| Birmingham Women's and Children's NHS Foundation Trust | Recruiting | Birmingham | West Midlands | B4 6NH | United Kingdom |
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| Great Ormond Street Hospital | Recruiting | London | WC1N 3JH | United Kingdom |
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| Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language. | View source |
| ID | Term |
|---|---|
| C400401 | maribavir |
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