A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Children and Teenage Transplant Recipients With CMV Infection

A Phase 3, Open-label, Single-arm, Repeated-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)

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) adult tablet formulation or other formulation based on PK modeling.

The participants will be treated with maribavir for 8 weeks.

Participants need to visit their doctor during 12-week follow-up period.

Study Overview

• Status: Recruiting
• Conditions: Cytomegalovirus (CMV)
• Intervention / Treatment: Drug: Maribavir

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Recruiting
      • Sydney Children's Hospital
      • Contact: Site Contact; Phone Number: +61293821690; Email: adam.nelson@health.nsw.gov.au
      • Principal Investigator: Adam Nelson, MD
  • Queensland
    • Woollangabba, Queensland, Australia, 4101
      • Recruiting
      • Queensland Children's Hospital
      • Contact: Site Contact; Phone Number: +61393455522; Email: Trisha.SoosayRaj@health.qld.gov.au
      • Principal Investigator: Trisha Soosay Raj, MD
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • Perth Children's Hospital
      • Contact: Site Contact; Phone Number: +61893408222; Email: michelle.ng@health.wa.gov.au
      • Principal Investigator: Michelle Ng, MD
• Belgium
  • Brussels, Belgium, 1020
    • Recruiting
    • Hôpital Universitaire des Enfants Reine Fabiola
    • Contact: Site Contact; Phone Number: +3224773100; Email: christine.devalck@hubruxelles.be
    • Principal Investigator: Christine Devalck, MD
  • Brussels
    • Sint-Lambrechts-Woluwe, Brussels, Belgium, 1200
      • Recruiting
      • Cliniques Universitaires Saint-Luc
      • Contact: Site Contact; Phone Number: +3227641387; Email: xavier.stephenne@saintluc.uclouvain.be
      • Principal Investigator: Xavier Stephenne, MD
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Gent
      • Contact: Site Contact; Phone Number: +3293325860; Email: victoria.bordon@uzgent.be
      • Principal Investigator: Victoria Bordon
• Brazil
  • São Paulo, Brazil, 04038-002
    • Recruiting
    • Hospital Do Rim E Hipertensão
    • Contact: Site Contact; Phone Number: +551150878000; Email: heliotedesco@medfarm.com.br
    • Principal Investigator: Helio Tedesco Silva, MD
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
      • Recruiting
      • Irmandade Da Santa Casa de Misericordia de Porto Alegre
      • Contact: Site Contact; Phone Number: +555132148640; Email: cdruckgarcia@gmail.com
      • Principal Investigator: Clotilde Druck Garcia, MD
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Recruiting
      • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
      • Contact: Site Contact; Phone Number: +555133598317; Email: ldaudt@hcpa.edu.br
      • Principal Investigator: Liane Esteves Daudt, MD
• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Children's Hospital Capital Institute of Pediatrics
      • Principal Investigator: Rong Liu, MD
      • Contact: Site Contact; Phone Number: +8613601123876; Email: liurong201305@sina.com
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Shanghai Children's Medical Center
      • Principal Investigator: Jing Chen
      • Contact: Site Contact; Phone Number: +8618930830632; Email: chenjingscmc@hotmail.com
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
      • Contact: Site Contact; Phone Number: +8613752090418; Email: xfzhu1981@126.com
      • Principal Investigator: Xiaofan Zhu, MD
• France
  • Paris, France, 75015
    • Recruiting
    • Hopital Necker
    • Contact: Site Contact; Phone Number: +33144494622; Email: pierre.frange@aphp.fr
    • Principal Investigator: Pierre Frange, MD, PhD
  • Ille-et-Vilaine
    • Rennes, Ille-et-Vilaine, France, 35000
      • Recruiting
      • CHU de Rennes - Hôpital Pontchaillou
      • Principal Investigator: Virginie Gandemer
      • Contact: Site Contact; Phone Number: +33299265835; Email: virginie.gandemer@chu-rennes.fr
  • Isère
    • La Tronche, Isère, France, 38700
      • Recruiting
      • CHU de Grenoble Alpes - Hôpital Michallon
      • Principal Investigator: Gaelle Stofleth, MD
      • Contact: Site Contact; Phone Number: +33476765911; Email: gstofleth@chu-grenoble.fr
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44000
      • Recruiting
      • CHRU Nantes
      • Contact: Site Contact; Phone Number: +33240083610; Email: Fanny.RIALLAND@chu-nantes.fr
      • Principal Investigator: Fanny Rialland, MD
• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg Eppendorf
    • Contact: Site Contact; Phone Number: +4940741052720; Email: i.mueller@uke.de
    • Principal Investigator: Ingo Müller, MD, MSc, PhD
  • Bayern
    • Würzburg, Bayern, Germany, 97080
      • Recruiting
      • Universitätsklinikum Würzburg
      • Contact: Site Contact; Phone Number: +4993120127999; Email: woelfl_m@ukw.de
      • Principal Investigator: Matthias Wölfl, MD
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Recruiting
      • Medizinische Hochschule Hannover
      • Contact: Site Contact; Phone Number: +495115326747; Email: maecker.britta@mh-hannover.de
      • Principal Investigator: Britta Maecker-Kolhoff, MD
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Recruiting
      • Universitatsklinikum Münster
      • Contact: Site Contact; Phone Number: +492518343415; Email: andreas.groll@ukmuenster.de
      • Principal Investigator: Andreas Groll, MD
  • Thüringen
    • Jena, Thüringen, Germany, 07747
      • Recruiting
      • Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
      • Contact: Site Contact; Phone Number: +493641328134; Email: bernd.gruhn@med.uni-jena.de
      • Principal Investigator: Bernd Gruhn, MD, PhD
• Israel
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Medical Center - PPDS
    • Contact: Site Contact; Phone Number: +97247774798; Email: r_gefen@rambam.health.gov.il
    • Principal Investigator: Aharon (Roni) Gefen, MD
  • Jerusalem, Israel, 911
    • Recruiting
    • Hadassah Medical Center - PPDS
    • Contact: Site Contact; Phone Number: +97226417095; Email: udi.evenor@gmail.com
    • Principal Investigator: Ehud Even-Or, MD
  • Tel-Aviv
    • Ramat Gan, Tel-Aviv, Israel, 52394
      • Recruiting
      • The Chaim Sheba Medical Center - PPDS
      • Contact: Site Contact; Phone Number: +97235303030; Email: bella.bielorai@sheba.health.gov.il
      • Principal Investigator: Bella Bielorai, MD
    • Tel Aviv-Yafo, Tel-Aviv, Israel, 64239
      • Recruiting
      • Tel Aviv Sourasky Medical Center - PPDS
      • Contact: Site Contact; Phone Number: +972524266464; Email: ronite@tlvmc.gov.il
      • Principal Investigator: Ronit Elhasid, MD
• Japan
  • Chiba-Shi, Japan, 650-0047
    • Recruiting
    • Hyogo Prefectural Kobe Children's Hospital
    • Contact: Site Contact; Phone Number: +81789457300; Email: hasegawa_kch@hp.pref.hyogo.jp
    • Principal Investigator: Daiichiro Hasegawa, MD
  • Aiti
    • Nagoya-Shi, Aiti, Japan, 453-0046
      • Recruiting
      • National Center for Child Health and Development
      • Contact: Site Contact; Phone Number: +81524815111; Email: hirotoshi_sakaguchi@mac.com
      • Principal Investigator: Hirotoshi Sakaguchi, MD, PhD
  • Kanagawa
    • Isehara-Shi, Kanagawa, Japan, 259-1143
      • Recruiting
      • Saitama Children's Medical Center
      • Contact: Site Contact; Phone Number: +81463931121; Email: ko.katsuyoshi@scmc.pref.saitama.jp
      • Principal Investigator: Katsuyoshi Koh, MD
  • Sizuoka
    • Aoi-ku, Sizuoka, Japan, 420-8660
      • Recruiting
      • Shizuoka Children's Hospital
      • Contact: Site Contact; Phone Number: +81542476251; Email: wataken@kuhp.kyoto-u.ac.jp
      • Principal Investigator: Kenichiro Watanabe
  • Ôsaka
    • Izumi-Shi, Ôsaka, Japan, 594-1101
      • Recruiting
      • Osaka Women's and Children's Hospital
      • Contact: Site Contact; Phone Number: +81725561220; Email: asawada@mch.pref.osaka.jp
      • Principal Investigator: Akihisa Sawada, MD, PhD
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitario Vall d´Hebron- PPDS
    • Contact: Site Contact; Phone Number: +34 934893000; Email: pere.soler@vallhebron.cat
    • Principal Investigator: Pere Soler Palacin, MD
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz - PPDS
    • Contact: Site Contact; Phone Number: +34917277223; Email: david.bueno@salud.madrid.org
    • Principal Investigator: David Bueno Sanchez
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Infantil Universitario Niño Jesus - PIN
    • Contact: Site Contact; Phone Number: +34 630667275; Email: blanca.molina@salud.madrid.org
    • Principal Investigator: Blanca Molina
  • Barcelona
    • Espluges De Llobregat, Barcelona, Spain, 08950
      • Recruiting
      • Hospital Sant Joan de Deu - PIN
      • Contact: Site Contact; Phone Number: +34 932532100; Email: claudia.fortuny@sjd.es
      • Principal Investigator: Claudia Fortuny Guasch, MD
  • Málaga
    • Malaga, Málaga, Spain, 29011
      • Recruiting
      • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
      • Contact: Site Contact; Phone Number: +34686595189; Email: pascualmartinez5@hotmail.com
      • Principal Investigator: Antonia Pascual Martinez, MD
• United Kingdom
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M13 9WL
      • Recruiting
      • Royal Manchester Children's Hospital
      • Principal Investigator: Robert Wynn
      • Contact: Site Contact; Phone Number: +441612761234; Email: Robert.Wynn@mft.nhs.uk
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Recruiting
      • Nottingham University Hospitals NHS Trust
      • Contact: Site Contact; Phone Number: +448888888888; Email: drew.maxted@nuh.nhs.uk
      • Principal Investigator: Andrew (Drew) Maxted, MD
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B4 6NH
      • Recruiting
      • Birmingham Women's and Children's NHS Foundation Trust
      • Contact: Site Contact; Phone Number: +441213338252; Email: girishgupte@nhs.net
      • Principal Investigator: Girish Gupte, MD
• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198-7680
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Site Contact; Phone Number: 402-559-8929; Email: ncastilloalmeida@unmc.edu
      • Principal Investigator: Natalia Castillo Almeida, MD
  • Texas
    • Fort Worth, Texas, United States, 76104-2733
      • Recruiting
      • Cook Children's Health Care System
      • Contact: Site Contact; Phone Number: 682-885-8084; Email: Richard.Howrey@cookchildrens.org
      • Principal Investigator: Richard Howrey, MD
    • Houston, Texas, United States, 77030-4009
      • Recruiting
      • University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
      • Contact: Site Contact; Phone Number: 713-792-3497; Email: ptewari@mdanderson.org
      • Principal Investigator: Priti Tewari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participant, as age appropriate, 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 capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site.
• Be a male or female child or adolescent < 18 years of age at the time of consent. For participants in Cohort 3 only, must have a gestational age of at least 38 weeks and a minimum weight of 5 kg.
• Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
• Have a documented CMV infection, with a CMV deoxyribonucleic acid (DNA) screening value of >= 1365 International Units per milliliter (IU/mL) in whole blood or >= 455 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 must be taken within 14 days of first dose of study drug, with the second sample obtained within 5 days prior to first dose of study drug. The same laboratory and same sample type (whole blood or plasma) must be used for both assessments.

• Have all the following results as part of screening laboratory assessments:

  • Absolute neutrophil count >= 500 per cubic millimeter (/mm^3) (0.5 × 10^9 per liter [/L])
  • Platelet count >= 15,000/mm^3 (15 × 10^9/L)
  • Hemoglobin >= 8 grams per deciliter (g/dL)
• Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz equation) >= 30 milliliters per minute (mL/min) /1.73 meter square (m^2).
• Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta-human chorionic gonadotropin (β-hCG) pregnancy test at screening. Males, or nonpregnant, nonlactating females who are sexually active must agree to comply with the applicable contraceptive requirements of this protocol during the study treatment administration period and for 90 days after the last dose of study treatment.
• Have life expectancy of >= 8 weeks.
• Be willing and have an understanding and ability to fully comply with the study procedures and restrictions defined in the protocol. For younger children, the parent/both parents or LAR must meet this criterion.

Exclusion Criteria:

• Have CMV tissue invasive disease involving the central nervous system (CNS) or retina as assessed by the investigator at the time of screening.
• Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
• Have a history of clinically relevant alcohol or drug abuse that may interfere with treatment compliance or assessments with the protocol as determined by the investigator.
• Be receiving valganciclovir, ganciclovir, cidofovir, foscarnet, leflunomide, letermovir, or artesunate when study treatment is initiated, or anticipated to require one of these agents during the 8-week treatment period.
• Have a known hypersensitivity to maribavir or to any excipients.
• Have severe vomiting, diarrhea, or other severe gastrointestinal (GI) illness within 24 hours prior to the first dose of study treatment or a GI absorption abnormality that would preclude administration of oral medication.
• Require mechanical ventilation or vasopressors for hemodynamic support at baseline (Week 0).
• Be pregnant (or expecting to conceive) or nursing.
• Have previously completed, discontinued, or have been withdrawn from this study.
• Have received any investigational agent or device within 30 days before initiation of study treatment (includes CMV specific T-cells). Previously approved agents under investigation for additional indications are not exclusionary.
• Have previously received maribavir or CMV vaccine at any time.
• Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the study treatment, or compromise the safety or well-being of the participant.
• Have severe liver disease (Child-Pugh score of >= 10).
• Have serum aspartate aminotransferase greater than (>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase > 5 times ULN at screening, or total bilirubin >= 3.0 times ULN at screening (except for documented Gilbert's syndrome), as analyzed by local laboratory.
• Have positive results for human immunodeficiency virus (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 B or hepatitis C.
• Requiring ongoing treatment with or an anticipated need for treatment with a strong cytochrome P450 3A (CYP3A) inducer.
• Have a low body weight where total blood volume (TBV) required during study participation will exceed 1 percent (%) TBV per study visit or 3% TBV over 30-day period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 3: Maribavir; Participants with 0 to < 6 years of age will receive maribavir based on PK modeling.	Drug: Maribavir; Participants will receive maribavir.; Other Names: TAK-620
Experimental: Cohort 1: Maribavir 400 or 200 mg; 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) twice daily (BID) based on body weight >= 25 kilogram (kg) or 200 mg tablet BID based on body weight 10 to < 25 kg orally for up to 8 weeks treatment period (Day 0/Week 0 to Day 56/Week 8). The dosing regimen will be based on the participant's body weight and may be updated over the course of the study based on the internal interim analyses on PK, safety, and tolerability of at least 5 participants in each cohort.	Drug: Maribavir; Participants will receive maribavir.; Other Names: TAK-620
Experimental: Cohort 2: Maribavir 400 or 200 mg; Participants with >= 6 to < 12 years of age will receive maribavir 400 mg (2*200 mg tablets) BID based on body weight >= 25 kg or 200 mg tablet BID based on body weight 10 to < 25 kg orally for up to 8 weeks treatment period (Day 0/Week 0 to Day 56/Week 8). The dosing regimen will be based on the participant's body weight and may be updated over the course of the study based on the internal interim analyses on PK, safety, and tolerability of at least 5 participants in each cohort.	Drug: Maribavir; Participants will receive maribavir.; Other Names: TAK-620

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)
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.	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)
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 and 2 to 4 hours post-dose on Day 56 (Week 8)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs	An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE is 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 worsens in either intensity or frequency following exposure to the investigational product or medicinal product. An SAE is any untoward medical occurrence (whether considered related to investigational product or not and at any dose) that at any dose results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality or birth defect, an important medical event. TEAEs included serious and non-serious AEs.	From start of study drug administration up to follow-up (Week 20)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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.	At Week 8
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
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
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

Collaborators and Investigators

• Sponsor: Takeda
• Collaborators: Takeda Development Center Americas, Inc.
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): November 22, 2026

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Estimated): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections; Anti-Infective Agents; Antiviral Agents; Maribavir
• Other Study ID Numbers: TAK-620-2004; 2021-004279-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes