A 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)

May 20, 2026 updated by: Takeda

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) 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Minderoo Children's Comprehensive Cancer Centre
        • Principal Investigator:
          • Adam Nelson, MD
        • Contact:
    • Queensland
      • Woollangabba, Queensland, Australia, 4101
        • Recruiting
        • Queensland CHILDREN'S HOSPITAL
        • Principal Investigator:
          • Trisha Soosay Raj, MD
        • Contact:
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Royal Children's Hospital Melbourne - PIN
        • Contact:
        • Principal Investigator:
          • Theresa Cole, MD
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Perth Children's Hospital
        • Contact:
        • Principal Investigator:
          • Michelle Ng, MD
  • Belgium
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1020
        • Recruiting
        • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
        • Contact:
        • Principal Investigator:
          • Christine Devalck, MD
      • Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
        • Principal Investigator:
          • Victoria Bordon
  • Brazil
      • São Paulo, Brazil, 04038-002
        • Recruiting
        • Hospital do Rim e Hipertensão
        • Principal Investigator:
          • Helio Tedesco Silva, MD
        • Contact:
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
        • Recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
        • Contact:
        • 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:
        • Principal Investigator:
          • Laura Fogliatto, MD
      • Porto Alegre, Rio Grande do Sul, Brazil, 05403-000
        • Recruiting
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
        • Contact:
        • Principal Investigator:
          • Juliana Folloni Fernandes, MD
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100020
        • Recruiting
        • Capital Center For Children's Healthy, Capital Medical University
        • Principal Investigator:
          • Rong Liu, MD
        • Contact:
      • Beijing, Beijing Municipality, China, 100045
        • Recruiting
        • Beijing Children's Hospital, Capital Medical University - PIN
        • Contact:
        • Principal Investigator:
          • Maoquan Qin
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University - Main
        • Contact:
        • Principal Investigator:
          • Changxi Wang, MD
      • Shenzhen, Guangdong, China, 518038
        • Recruiting
        • Shenzhen Children's Hospital
        • Principal Investigator:
          • Sixi Liu, MD
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Shanghai Children's Medical Center - Zhangjiang Campus
        • Principal Investigator:
          • Jing Chen
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS
        • Contact:
        • Principal Investigator:
          • Xiaofan Zhu, MD
  • France
      • Paris, France, 75015
        • Recruiting
        • Hôpital Necker
        • Contact:
        • Principal Investigator:
          • Pierre Frange, MD
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35200
        • Recruiting
        • CHU de Rennes - Hopital Pontchaillou
        • Principal Investigator:
          • Virginie Gandemer
        • Contact:
    • Isère
      • La Tronche, Isère, France, 38700
        • Recruiting
        • CHU de Grenoble Alpes - Hôpital Michallon
        • Principal Investigator:
          • Gaelle Stofleth, MD
        • Contact:
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Recruiting
        • CHRU Nantes
        • Principal Investigator:
          • Caroline Thomas, MD
        • Contact:
  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitatsklinikum Hamburg Eppendorf
        • Contact:
        • Principal Investigator:
          • Ingo Müller, MD, MSc, PhD
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
        • Principal Investigator:
          • Britta Maecker-Kolhoff, MD
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • Recruiting
        • Universitatsklinikum Wurzburg
        • Contact:
        • Principal Investigator:
          • Matthias Wölfl, MD
    • North Rhine-Westphalia
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
        • Contact:
        • Principal Investigator:
          • Andreas Groll, MD
    • Thuringia
      • Jena, Thuringia, Germany, 07745
        • Recruiting
        • Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101
        • Contact:
        • Principal Investigator:
          • Bernd Gruhn, MD, PhD
  • Israel
      • Haifa, Israel, 31096
        • Recruiting
        • Rambam Health Care Campus - PPDS
        • Contact:
        • Principal Investigator:
          • Aharon (Roni) Gefen, MD
      • Petah Tikva, Israel, 4920235
        • Recruiting
        • Hadassah Medical Center- Ein Kerem - PPDS
        • Contact:
        • Principal Investigator:
          • Ehud Even-Or, MD
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 52394
        • Recruiting
        • The Chaim Sheba Medical Center - PPDS
        • Contact:
        • Principal Investigator:
          • Bella Bielorai, MD
      • Tel Aviv, Tel Aviv, Israel, 64239
        • Recruiting
        • Tel Aviv Sourasky Medical Center Ichilov - PPDS
        • Contact:
        • Principal Investigator:
          • Ronit Elhasid, MD
  • Japan
      • Chiba, Japan, 650-0047
        • Recruiting
        • Hyogo Prefectural Kobe Children's Hospital
        • Contact:
        • Principal Investigator:
          • Daiichiro Hasegawa, MD
    • Saitama
      • Saitama-Shi Chuo-Ku, Saitama, Japan, 330-8777
        • Recruiting
        • Saitama Prefectural Children's Medical Center
        • Principal Investigator:
          • Katsuyoshi Koh, MD
        • Contact:
    • Shizuoka
      • Aoi-ku, Shizuoka, Japan, 420-8660
        • Recruiting
        • Shizuoka Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kenichiro Watanabe, MD
    • Tokyo
      • Setagaya-Ku, Tokyo, Japan, 157-8535
        • Recruiting
        • National Center for Child Health and Development
        • Principal Investigator:
          • Hirotoshi Sakaguchi, MD, PhD
        • Contact:
    • Ôsaka
      • Izumi-Shi, Ôsaka, Japan, 594-1101
        • Recruiting
        • Osaka Women's and Children's Hospital
        • Principal Investigator:
          • Akihisa Sawada, MD, PhD
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d´Hebron- PPDS
        • Contact:
        • Principal Investigator:
          • Pere Soler Palacin, MD
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Infantil Universitario Niño Jesus - PIN
        • Contact:
        • Principal Investigator:
          • Blanca Molina
    • Barcelona
      • Espluges de Llobregat, Barcelona, Spain, 08950
        • Recruiting
        • Hospital Sant Joan de Deu - PIN
        • Principal Investigator:
          • Claudia Fortuny Guasch, MD
        • Contact:
    • Madrid
      • Horcajo de la Sierra, Madrid, Spain, 28755
        • Recruiting
        • Hospital Universitario La Paz - PPDS
        • Contact:
        • Principal Investigator:
          • David Bueno Sanchez, MD
    • Málaga
      • Málaga, Málaga, Spain, 29011
        • Recruiting
        • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil
        • Contact:
        • Principal Investigator:
          • Jorge Diez-Pastor, MD
  • United Kingdom
      • London, United Kingdom, WC1N 3JH
        • Recruiting
        • Great Ormond Street Hospital
        • Contact:
        • Principal Investigator:
          • Stephen Marks, MD
    • Lambeth
      • London, Lambeth, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital
        • Contact:
        • Principal Investigator:
          • Anita Verma, MD
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Recruiting
        • Royal Manchester Children's Hospital - PIN
        • Contact:
        • Principal Investigator:
          • Robert Wynn, MD
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Principal Investigator:
          • Andrew (Drew) Maxted, MD
        • Contact:
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Recruiting
        • Birmingham Women's and Children's NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Girish Gupte, MD
  • United States
    • Delaware
      • Wilmington, Delaware, United States, 19803-3607
        • Recruiting
        • Nemours Children's Health - Wilmington - PIN
        • Principal Investigator:
          • Emi Caywood, MD
        • Contact:
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital - Main - PIN
        • Contact:
        • Principal Investigator:
          • Minelys Alicea Marrero, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN
        • Contact:
        • Principal Investigator:
          • Taylor Heald-Sargent, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4113
        • Recruiting
        • University of Nebraska Medical Center -985400 Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Kari Neemann, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3026
        • Recruiting
        • Cincinnati Children's Hospital Medical Center - PIN
        • Contact:
        • Principal Investigator:
          • Lara Danziger-Isakov, MD, MPH
    • Texas
      • Fort Worth, Texas, United States, 76104-2733
        • Recruiting
        • Cook Children's Health Care System
        • Contact:
        • Principal Investigator:
          • Richard Howrey, MD
      • Houston, Texas, United States, 77030-4000
        • Recruiting
        • University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd
        • Contact:
        • Principal Investigator:
          • Priti Tewari, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital - Wallace Tower - PIN
        • Contact:
        • Principal Investigator:
          • Claire Bocchini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 13 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.
  • Be a male or female child or adolescent < 18 years of age at the time of consent. For participants in Cohort 3 only (0 to <6 years) must have a gestational age of at least 39 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 which may be a first episode of post-transplant CMV viremia (primary or reactivation) or refractory to other anti-CMV treatments, with a CMV 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 laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative nucleic acid amplification test (qNAAT) results. Quantitative assays must be standardized to the World Health Organization (WHO) CMV International Standard. 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. If documented and verified values are available in medical history that fulfill this criterion entirely, they may be used instead.
  • 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) (>=80 grams per liter [g/L]).
  • 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.
  • Participants must have a confirmed negative human immunodeficiency virus (HIV) test result within 3 months of first dose of study drug or, if unavailable, be tested by a local laboratory during the screening period.

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 (Visit 2/Day 1/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) or plan to receive an investigational agent or device during the study.

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 HIV.
  • 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 a 4-week period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Maribavir 400, 200 or 100 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 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).
Drug: Maribavir
Participants will receive maribavir.
Other Names:
  • TAK-620
Experimental: Cohort 2: Maribavir 400, 200 or 100 mg
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).
Drug: Maribavir
Participants will receive maribavir.
Other Names:
  • TAK-620
Experimental: Cohort 3: Maribavir 400, 200, 100 or 50 mg
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).
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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
Time Frame: 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)
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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
Time Frame: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)
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)
Time Frame: From start of study drug administration up to follow-up (Week 20)
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)

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
Time Frame: 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
Time Frame: Up to Week 20
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
Time Frame: Baseline up to Week 20
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
Time Frame: At Weeks 1, 4, and 8
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
Time Frame: 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
Time Frame: Up to Week 20
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
Time Frame: From Week 8 through Week 20
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
Time Frame: Up to Week 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Collaborators

Takeda Development Center Americas, Inc.

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Estimated)

January 18, 2027

Study Completion (Estimated)

January 18, 2027

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 (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-620-2004
  • 2021-004279-15 (EudraCT Number)
  • jRCT2031230753 (Registry Identifier: jRCT)
  • 2023-508988-73-00 (Ctis: EU Trial 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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