Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-004279-15
    Sponsor's Protocol Code Number:TAK-620-2004
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-09-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-004279-15
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to validate health outcomes of maribavir for the treatment of cytomegalovirus (CMV) infection in children and adolescents who have received transplant
    A.3.2Name or abbreviated title of the trial where available
    Protego
    A.4.1Sponsor's protocol code numberTAK-620-2004
    A.5.4Other Identifiers
    Name:INDNumber:IND 051001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/335/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center Americas, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Center Americas, Inc.
    B.5.2Functional name of contact pointRobert Bradley
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avenue
    B.5.3.2Town/ cityLexington MA
    B.5.3.3Post code02 421
    B.5.3.4CountryUnited States
    B.5.4Telephone number001781482 1638
    B.5.6E-mailrobert.bradley@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1133
    D.3 Description of the IMP
    D.3.1Product nameMaribavir
    D.3.2Product code TAK-620
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMARIBAVIR
    D.3.9.1CAS number 176161-24-3
    D.3.9.2Current sponsor codeTAK-620
    D.3.9.3Other descriptive nameserine/threonine kinase inhinitor
    D.3.9.4EV Substance CodeSUB03090MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)
    E.1.1.1Medical condition in easily understood language
    Cytomegalovirus (CMV) infection in children and adolescents who have received a transplant
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021829
    E.1.2Term Infection in solid organ transplant recipients
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021819
    E.1.2Term Infection in marrow transplant recipients
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To characterize the pharmacokinetics (PK) of maribavir and identify dosing regimens for CMV infection treatment in pediatric HSCT and SOT subjects from 0 years to <18years of age.
    2. To assess the safety and tolerability of maribavir in children and adolescents.
    E.2.2Secondary objectives of the trial
    1. To evaluate the antiviral activity of maribavir in CMV viremia clearance at the end of Week8 regardless of the length of study treatment
    2. To assess the maintenance of CMV viremia clearance and symptom control achieved at Week8, through Week12 (4weeks post-treatment), Week16 (8weeks post-treatment), and Week20 (12weeks post-treatment)
    3.To evaluate the recurrence of CMV viremia during study-assigned treatment and in follow-up period after the subject discontinued from study-assigned treatment
    4.To evaluate the time to first confirmed viremia clearance 5. To evaluate the recurrence of CMV viremia requiring treatment during the 12-week follow-up period in subjects with confirmed viremia clearance at Week 8
    6. To assess the time course of changes in plasma CMV deoxyribonucleic acid (DNA) load from baseline(Visit 2/Day 0/Week 0)
    7. To assess the profile of mutations in the CMV genes conferring resistance to maribavir
    8. To assess the acceptability and palatability of maribavir
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Parent/both parents or LAR must provide signature of informed consent and there must be documentation of assent by the subject, as age appropriate, before completing any study-related procedures. During the coronavirus disease (COVID‑19) public health emergency, informed consent from a potential or current trial subject 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.Subjects must also;
    2.Be a male or female child or adolescent <18 years of age at the time of consent; for subjects in Cohort3 only, must have a minimum gestational age of at least 38 weeks and minimum weight of 5kg. 3.Be a recipient of an SOT or an HSCT that is functioning at the time of screening.
    4.Have a documented CMV infection, with a CMV DNA screening value of ≥1365IU/mL in whole blood or ≥455 IU/mL in plasma in 2 consecutive assessments within 14 days of first dose of study drug, separated by at least 1day, by qPCR or comparable quantitative CMV DNA results.
    5.Have all the following results as part of screening laboratory assessments:a.Absolute neutrophil count ≥500/mm3(0.5×109/L)b.Platelet count ≥15,000/mm3(15×109/L)c.Hemoglobin ≥7 g/dL.
    6.Have an estimated glomerular filtration rate (creatinine-based Bedside Schwartz equation)≥30mL/min/1.73 m2.
    7.Be a female of nonchildbearing potential. If a female of childbearing potential, have a negative serum human chorionic gonadotropin (hCG) or beta-hCG(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 90days after the last dose of study treatment.
    8.Be able to swallow awholetablet until a liquid formulation becomes available for the study.
    9.Have life expectancy of ≥8 weeks.
    10.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.
    E.4Principal exclusion criteria
    Subjects must not:
    1.Have CMV tissue invasive disease involving the central nervous system or retina as assessed by the investigator at the time of screening.
    2.Have uncontrolled other type of infection as assessed by the investigator on the date of enrollment.
    3.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.
    4.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.
    5.Have a known hypersensitivity to maribavir or to any excipients.
    6.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.
    7.Require mechanicalventilation or vasopressors for hemodynamic support at baseline(Visit2/Day0/Week0).
    8.Be pregnant (or expecting to conceive) or nursing.
    9.Have previously completed, discontinued, or have been withdrawn from this study.
    10.Have received an investigational agentor devicewithin 30 days before initiation of study treatment (includes any investigational agent with known anti-CMV activity, and CMV-specific T-cells). Previously approved agents under investigation for additional indications are not exclusionary.
    11.Have previously received maribavir or CMV vaccine at any time.
    12.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 theassigned study treatment, or compromise the safety or well-being of the subject.
    13.Have severe liver disease (Child-Pugh score of ≥10).
    14.Have serum aspartate aminotransferase >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.
    15.Have known (previously documented) positive results for human immunodeficiency virus (HIV). Subjects 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.
    16.Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Subjects 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.
    17.Be undergoing treatment for acute or chronic hepatitis B or hepatitis C.
    E.5 End points
    E.5.1Primary end point(s)
    1. Pharmacokinetic parameters at steady state at Week1 including maximum observed plasma concentration (Cmax), time when Cmaxis observed (Tmax), maribavir minimum concentration predose (Cmin), area under the plasma concentration-time curve over the 1 dosing interval of 12hours at steady state (AUC0-tau), half-life (t1/2), terminal elimination rate constant (λz), apparent volume of distribution (Vz/F), and apparent oral clearance (CL/F) based on serial PK samples collected at Week1. Cminat Week4 (predose) and Week 8 (predose and 2 to 4 hours after the morning dose).
    2. Safety and tolerability assessments: serious adverse events (SAEs), adverse events (AEs) (including instances of CMV disease), vital signs, clinical laboratory evaluations at specified visits, ECGs, and discontinuations from the study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Week 1, 4, 8
    2) Between Baseline and End of Study (EOS)
    E.5.2Secondary end point(s)
    1. Achievement of the confirmed clearance of plasma CMV DNA (ie, 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.
    2. Maintenance of CMV viremia clearance and symptom control achieved at Week8 through Week 12 (4 weeks post-treatment period), Week16 (8 weeks post-treatment period), and Week20 (12weeks post-treatment period).
    3. Recurrence of CMV viremia during study-assigned treatment and in the follow-up period after the subject is discontinued from study-assigned treatment.
    4. Time to first confirmed viremia clearance at any time during the study.
    5. Recurrence treated with alternative anti-CMV treatment in the 12-week follow-up period in subjects with confirmed viremia clearance at Week 8.
    6. Changes in plasma CMV DNA load from baseline(Visit 2/Day0/Week0)by study week.
    7. Maribavir CMV resistance profile.
    8. Acceptability and palatability assessment of maribavir at Weeks 1, 4, and 8 (or end of treatment).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Week 8
    2) Week 8 through Week 12, 16 and 20
    3) During 8 week treatment an follow-up period
    4) During the study
    5) 12-week follow-up period in subjects
    with confirmed viremia clearance at Week 8
    6) from baseline by study week
    7) During the study
    8) Weeks 1, 4, and 8 (or end of treatment)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Palatability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    China
    Israel
    Japan
    United States
    France
    Spain
    Germany
    Belgium
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study is planned to be completed in approximately 48 months. The study completion date is defined as the date on which the last subject in the study completes the final protocol-defined assessment(s). This includes the follow-up visit or contact (in person and/or by phone or video), whichever is later
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 3
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 47
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 27
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pediatric
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No aftercare is planned for this study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-08-31
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 03 22:17:59 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA