AzTrials
AzTrials

Cytomegalovirus (CMV)Phase 3NCT05319353

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)

A Phase 3 study testing Maribavir in people with Cytomegalovirus (CMV), run by Takeda at 53 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Cytomegalovirus (CMV)
What is being tested?
Maribavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
53 sitesin 11 countries
Study dates
13 Nov 2023to 18 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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])
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

53 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

53 sites in 11 countries

United States8 sites, 8 recruiting

  • Ann and Robert H Lurie Childrens Hospital of Chicago - PIN

    Chicago, Illinois, 60611

    Site Contact, 312-227-4688, thsargent@luriechildrens.org

    Taylor Heald-Sargent, MD

    Recruiting

  • Cincinnati Children's Hospital Medical Center - PIN

    Cincinnati, Ohio, 45229-3026

    Site Contact, 513-636-9101, lara.danziger-isakov@cchmc.org

    Lara Danziger-Isakov, MD, MPH

    Recruiting

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104-2733

    Site Contact, 682-885-8084, richard.howrey@cookchildrens.org

    Richard Howrey, MD

    Recruiting

  • University of Texas MD Anderson Cancer Center - 1515 Holcombe Blvd

    Houston, Texas, 77030-4000

    Site Contact, 713-792-3497, ptewari@mdanderson.org

    Priti Tewari, MD

    Recruiting

  • Texas Children's Hospital - Wallace Tower - PIN

    Houston, Texas, 77030

    Site Contact, 832-824-1779, cb135591@bcm.edu

    Claire Bocchini

    Recruiting

  • University of Nebraska Medical Center -985400 Nebraska Medical Center

    Omaha, Nebraska, 68114-4113

    Site Contact, 402-559-6463, kneemann@unmc.edu

    Kari Neemann, MD

    Recruiting

  • Johns Hopkins All Children's Hospital - Main - PIN

    St. Petersburg, Florida, 33701

    Site Contact, 727-767-5002, malicea4@jh.edu

    Minelys Alicea Marrero, MD

    Recruiting

  • Nemours Children's Health - Wilmington - PIN

    Wilmington, Delaware, 19803-3607

    Site Contact, 302-651-5584, emi.caywood@nemours.org

    Emi Caywood, MD

    Recruiting

Other trials in United States

China6 sites, 6 recruiting

  • Capital Center For Children's Healthy, Capital Medical University

    Beijing, Beijing Municipality, 100020

    Site Contact, 8613601123876, liurong201305@sina.com

    Rong Liu, MD

    Recruiting

  • Beijing Children's Hospital, Capital Medical University - PIN

    Beijing, Beijing Municipality, 100045

    Site Contact, +8613601203966, Maoquan.Qin@outlook.com

    Maoquan Qin

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University - Main

    Guangzhou, Guangdong, 510080

    Site Contact, +8613600450862, wangchx@mail.sysu.edu.cn

    Changxi Wang, MD

    Recruiting

  • Shanghai Children's Medical Center - Zhangjiang Campus

    Shanghai, Shanghai Municipality, 200127

    Site Contact, 8618930830632, chenjingscmc@hotmail.com

    Jing Chen

    Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518038

    Site Contact, +8618938690206, tiger647@126.com

    Sixi Liu, MD

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences - PPDS

    Tianjin, Tianjin Municipality, 300020

    Site Contact, +8613752090418, xfzhu1981@126.com

    Xiaofan Zhu, MD

    Recruiting

Other trials in China

Germany5 sites, 5 recruiting

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

    Site Contact, +4940741052720, i.mueller@uke.de

    Ingo Müller, MD, MSc, PhD

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Site Contact, +495115326747, maecker.britta@mh-hannover.de

    Britta Maecker-Kolhoff, MD

    Recruiting

  • Universitatsklinikum Jena - Am Klinikum 1-Erlanger Allee 101

    Jena, Thuringia, 07745

    Site Contact, +493641328134, bernd.gruhn@med.uni-jena.de

    Bernd Gruhn, MD, PhD

    Recruiting

  • Universitätsklinikum Münster

    Münster, North Rhine-Westphalia, 48149

    Site Contact, +492518343415, andreas.groll@ukmuenster.de

    Andreas Groll, MD

    Recruiting

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

    Site Contact, +4993120127999, woelfl_m@ukw.de

    Matthias Wölfl, MD

    Recruiting

Other trials in Germany

Japan5 sites, 5 recruiting

  • Shizuoka Children's Hospital

    Aoi-ku, Shizuoka, 420-8660

    Site Contact, +81542476251, wataken@kuhp.kyoto-u.ac.jp

    Kenichiro Watanabe, MD

    Recruiting

  • Hyogo Prefectural Kobe Children's Hospital

    Chiba, 650-0047

    Site Contact, +81789457300, hasegawa_kch@hp.pref.hyogo.jp

    Daiichiro Hasegawa, MD

    Recruiting

  • Osaka Women's and Children's Hospital

    Izumi-Shi, Ôsaka, 594-1101

    Site Contact, +81725561220, asawada@wch.opho.jp

    Akihisa Sawada, MD, PhD

    Recruiting

  • Saitama Prefectural Children's Medical Center

    Saitama-Shi Chuo-Ku, Saitama, 330-8777

    Site Contact, 81463931121, ko.katsuyoshi@saitama-pho.jp

    Katsuyoshi Koh, MD

    Recruiting

  • National Center for Child Health and Development

    Setagaya-Ku, Tokyo, 157-8535

    Site Contact, +81334160181, sakaguchi-hi@ncchd.go.jp

    Hirotoshi Sakaguchi, MD, PhD

    Recruiting

Other trials in Japan

Spain5 sites, 5 recruiting

  • Hospital Universitario Vall d´Hebron- PPDS

    Barcelona, 08035

    Site Contact, +34 934893000, pere.soler@vallhebron.cat

    Pere Soler Palacin, MD

    Recruiting

  • Hospital Sant Joan de Deu - PIN

    Espluges de Llobregat, Barcelona, 08950

    Site Contact, +34932804000, claudia.fortuny@sjd.es

    Claudia Fortuny Guasch, MD

    Recruiting

  • Hospital Universitario La Paz - PPDS

    Horcajo de la Sierra, Madrid, 28755

    Site Contact, +34917277223, david.bueno@salud.madrid.org

    David Bueno Sanchez, MD

    Recruiting

  • Hospital Infantil Universitario Niño Jesus - PIN

    Madrid, 28009

    Site Contact, +34 630667275, blanca.molina@salud.madrid.org

    Blanca Molina

    Recruiting

  • Hospital Regional Universitario de Malaga - Hospital Materno-Infantil

    Málaga, Málaga, 29011

    Site Contact, +348888888888, jorgediezp@outlook.es

    Jorge Diez-Pastor, MD

    Recruiting

Other trials in Spain

United Kingdom5 sites, 5 recruiting

  • Birmingham Women's and Children's NHS Foundation Trust

    Birmingham, West Midlands, B4 6NH

    Site Contact, +441213338252, girishgupte@nhs.net

    Girish Gupte, MD

    Recruiting

  • King's College Hospital

    London, Lambeth, SE5 9RS

    Site Contact, 441132432799, anitaverma@nhs.net

    Anita Verma, MD

    Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH

    Site Contact, 442074059200, stephen.marks@gosh.nhs.uk

    Stephen Marks, MD

    Recruiting

  • Royal Manchester Children's Hospital - PIN

    Manchester, Lancashire, M13 9WL

    Site Contact, +441612761234, Robert.Wynn@mft.nhs.uk

    Robert Wynn, MD

    Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG5 1PB

    Site Contact, +448888888888, drew.maxted@nhs.net

    Andrew (Drew) Maxted, MD

    Recruiting

Other trials in United Kingdom

Australia4 sites, 4 recruiting

  • Perth Children's Hospital

    Nedlands, Western Australia, 6009

    Site Contact, +61893408222, michelle.ng@health.wa.gov.au

    Michelle Ng, MD

    Recruiting

  • Royal Children's Hospital Melbourne - PIN

    Parkville, Victoria, 3052

    Site Contact, +61393455522, theresa.cole@rch.org.au

    Theresa Cole, MD

    Recruiting

  • Minderoo Children's Comprehensive Cancer Centre

    Randwick, New South Wales, 2031

    Site Contact, 61293821690, adam.nelson@health.nsw.gov.au

    Adam Nelson, MD

    Recruiting

  • Queensland Children's Hospital

    Woollangabba, Queensland, 4101

    Site Contact, 61393455522, Trisha.SoosayRaj@health.qld.gov.au

    Trisha Soosay Raj, MD

    Recruiting

Other trials in Australia

Brazil4 sites, 4 recruiting

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    Porto Alegre, Rio Grande do Sul, 05403-000

    Site Contact, +555132178555, julianafolloni@gmail.com

    Juliana Folloni Fernandes, MD

    Recruiting

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

    Site Contact, +555132148640, cdruckgarcia@gmail.com

    Clotilde Druck Garcia, MD

    Recruiting

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Porto Alegre, Rio Grande do Sul, 90035-903

    Site Contact, +(55519) 963-5250, fogliattolaura@gmail.com

    Laura Fogliatto, MD

    Recruiting

  • Hospital Do Rim E Hipertensão

    São Paulo, 04038-002

    Site Contact, 551150878000, heliotedesco@medfarm.com.br

    Helio Tedesco Silva, MD

    Recruiting

Other trials in Brazil

France4 sites, 4 recruiting

  • CHU de Grenoble Alpes - Hôpital Michallon

    La Tronche, Isère, 38700

    Site Contact, +33476765911, gstofleth@chu-grenoble.fr

    Gaelle Stofleth, MD

    Recruiting

  • CHRU Nantes

    Nantes, Loire-Atlantique, 44000

    Site Contact, +33240083610, caroline.thomas@chu-nantes.fr

    Caroline Thomas, MD

    Recruiting

  • Hopital Necker

    Paris, 75015

    Site Contact, +(3314) 449-4622, pierre.frange@nck.aphp.fr

    Pierre Frange, MD

    Recruiting

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, 35200

    Site Contact, +33299265835, virginie.gandemer@chu-rennes.fr

    Virginie Gandemer

    Recruiting

Other trials in France

Israel4 sites, 4 recruiting

  • Rambam Health Care Campus - PPDS

    Haifa, 31096

    Site Contact, +97247774798, r_gefen@rambam.health.gov.il

    Aharon (Roni) Gefen, MD

    Recruiting

  • Hadassah Medical Center- Ein Kerem - PPDS

    Petah Tikva, 4920235

    Site Contact, +97226417095, udi.evenor@gmail.com

    Ehud Even-Or, MD

    Recruiting

  • The Chaim Sheba Medical Center - PPDS

    Ramat Gan, Tel Aviv, 52394

    Site Contact, +97235303030, bella.bielorai@sheba.health.gov.il

    Bella Bielorai, MD

    Recruiting

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    Tel Aviv, Tel Aviv, 64239

    Site Contact, +972524266464, ronite@tlvmc.gov.il

    Ronit Elhasid, MD

    Recruiting

Other trials in Israel

Belgium3 sites, 3 recruiting

  • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

    Brussels, Brussels Capital, 1020

    Site Contact, +3224773100, christine.devalck@hubruxelles.be

    Christine Devalck, MD

    Recruiting

  • UZ Gent

    Ghent, Oost-Vlaanderen, 9000

    Site Contact, +3293325860, victoria.bordon@uzgent.be

    Victoria Bordon

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Brussels Capital, 1200

    Site Contact, +3227641387, xavier.stephenne@saintluc.uclouvain.be

    Xavier Stephenne, MD

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Being tested
Maribavir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MaribavirDrug

    Also called TAK-620

    Participants will receive maribavir.

Study groups in NCT05319353
Study groupRoleWhat they receive
Cohort 1: Maribavir 400, 200 or 100 mgExperimentalParticipants 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).
Receives: Drug: Maribavir
Cohort 2: Maribavir 400, 200 or 100 mgExperimentalParticipants 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).
Receives: Drug: Maribavir
Cohort 3: Maribavir 400, 200, 100 or 50 mgExperimentalParticipants 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).
Receives: Drug: Maribavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of Maribavir

    Cmax of maribavir will be evaluated.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  2. Time to Maximum Observed Concentration (Tmax) of Maribavir

    Tmax of maribavir will be evaluated.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  3. Minimum Plasma Concentration (Cmin) of Maribavir

    Cmin of maribavir will be evaluated.

    Measured: 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)

  4. 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.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  5. Half-Life (t1/2) of Maribavir

    t1/2 of maribavir will be evaluated.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  6. Terminal Elimination Rate Constant (lambdaz) of Maribavir

    Lambdaz of maribavir will be evaluated.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  7. Apparent Volume of Distribution (Vz/F) of Maribavir

    Vz/F of maribavir will be evaluated.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  8. Apparent Oral Clearance (CL/F) of Maribavir

    CL/F of maribavir will be evaluated.

    Measured: Pre-dose; 0.5, 1.5, 3, 4, 6, and 8 hours post-dose on Day 7 (Week 1)

  9. 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.

    Measured: From start of study drug administration up to follow-up (Week 20)

Secondary outcomes (8)

  1. 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.

    Measured: At Week 8

  2. 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.

    Measured: At Week 8 through Weeks 12, 16, and 20

  3. 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.

    Measured: Up to Week 20

  4. 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.

    Measured: Up to Week 20

  5. 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.

    Measured: From Week 8 through Week 20

  6. 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.

    Measured: Baseline up to Week 20

  7. 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.

    Measured: Up to Week 12

  8. 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.

    Measured: At Weeks 1, 4, and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start13 Nov 2023
  3. Primary completion18 Jan 2027 (estimated)
  4. Study completion18 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Three dosing cohorts based on participant's age.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05319353
Sponsor's protocol ID
TAK-620-2004
Other IDs
2021-004279-15, jRCT2031230753, 2023-508988-73-00, 2023
Status last verified
May 2026
First submitted
1 Apr 2022
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38447094

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maribavir in people with Cytomegalovirus (CMV), run by Takeda at 53 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, China, Germany, Japan, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05319353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in