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    Summary
    EudraCT Number:2022-002374-82
    Sponsor's Protocol Code Number:TAK-620-3001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-11-21
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2022-002374-82
    A.3Full title of the trial
    A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoietic Stem Cell Transplant (HSCT) or Solid Organ Transplant (SOT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Maribavir in Japanese People With CMV Infection
    A.4.1Sponsor's protocol code numberTAK-620-3001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05137717
    A.5.4Other Identifiers
    Name:jRCTNumber:jRCT2021210056
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda
    B.1.3.4CountryJapan
    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 Pharmaceutical Company Limited
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address95 Hayden Avenue
    B.5.3.2Town/ cityLexington
    B.5.3.3Post codeMA 02421
    B.5.3.4CountryUnited States
    B.5.6E-mailTrialDisclosures@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; SHP620
    D.3.4Pharmaceutical form 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 nameSHP620
    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 Infection in Hematopoietic Stem Cell Transplant or Solid Organ Transplant Recipients
    E.1.1.1Medical condition in easily understood language
    Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant or Solid Organ Transplant Patients
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10011831
    E.1.2Term Cytomegalovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the efficacy of maribavir in CMV viremia clearance at the end of Study Week 8 (8 weeks after start of administration) in Japanese HSCT or SOT recipients with CMV infection.
    - To assess the safety and tolerability of maribavir in Japanese transplant recipients with CMV infection.
    E.2.2Secondary objectives of the trial
    -To assess maintenance of CMV viremia clearance and infection symptom control achieved at Study Week 8 (8 weeks after start of administration), through Study Week 12 (4 weeks of post-treatment), Study Week 16 (8 weeks of post-treatment), and Study Week 20 (12 weeks of post-treatment).
    -To evaluate the time to first confirmed CMV viremia clearance.
    -To evaluate the recurrence of confirmed CMV viremia requiring treatment during 12-week follow-up period in participants who achieved confirmed viremia clearance at Study Week 8.
    -To assess the time course of changes in plasma CMV viremia load from Baseline.
    -To evaluate the recurrence of CMV viremia during study treatment and in follow-up period after the participant is discontinued from study treatment.
    -To assess the profile of mutations in CMV genes conferring resistance to maribavir.
    -To assess CMV viremia clearance at cut-off value of 137 international units (IU)/mL at the end of Study Week 8.
    -To characterise PK of maribavir.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be Japanese with Japanese nationality, >=16 years of age at the time of consent.
    2. Be a recipient of hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) that is functioning at the time of Screening.
    3. Have a documented CMV infection with a screening value of >455 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by a central specialty laboratory qPCR or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to first dose of study treatment with the second sample obtained within 5 days prior to first dose of study treatment at Visit 2/Day 0.
    4. Have the current CMV infection after HSCT or SOT, either primary or reactivation, which, in the investigator's opinion, requires treatment and have any of the following.
    a. Asymptomatic participants: The participants do not have CMV tissue-invasive disease or CMV syndrome (SOT participants only) at Baseline, as determined by the investigator according to the criteria specified in the protocol.
    b. Refractory or resistant participants: The participant must have a current CMV infection that is refractory to the most recently administered of the anti-CMV treatment agent(s). Refractory is defined as documented failure to achieve >1 log10 (common logarithm to base 10) decrease in CMV DNA level in plasma after a 14 day or longer treatment period with IV ganciclovir/oral valganciclovir, or IV foscarnet.
    5. Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):
    a. Absolute neutrophil count >=1,000/millimeter (mm)^3 (1.0 × 10^9/liter [L])
    b. Platelet count >=25,000/mm^3 (25 × 10^9/L)
    c. Hemoglobin >=8 grams per deciliter (g/dL)
    d. Estimated creatinine clearance >=30 milliliters (mL)/minute (estimated glomerular filtration rate by Modification of Diet in Renal Disease)
    6. Be able to swallow tablets.
    7. Have life expectancy of >=8 weeks.
    8. Weigh >=40 kilograms (kg).
    E.4Principal exclusion criteria
    1. Have central nervous system (CNS) CMV tissue-invasive disease or CMV retinitis as assessed by the investigator at the time of Screening and prior to administration at Visit 2/Day 0.
    2. Be receiving valganciclovir, ganciclovir, foscarnet, or letermovir when study treatment is initiated, or anticipated to require 1 of these agents during the 8-week treatment period.
    NOTE: Participants receiving letermovir must discontinue 3 days prior to first dose of study treatment. Ganciclovir, valganciclovir, and foscarnet must be discontinued prior to the first dose of study treatment.
    3. Have known hypersensitivity to the active substance or to an excipient of the study treatments.
    4. Have severe vomiting, diarrhea, or other severe GI illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
    5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of Baseline.
    6. Pregnant or nursing female.
    7. Have received any investigational agent (including CMV-specific T-cells) with known anti-CMV activity within 30 days before initiation of the study treatment at any time.
    8. Have previously received maribavir.
    9. Have serum aspartate aminotransferase (AST) >5 times upper limit of normal (ULN) at Screening, or serum alanine aminotransferase (ALT) >5 times ULN at Screening, or total bilirubin >=3.0* ULN at Screening (except for documented Gilbert's syndrome), as analyzed by local or central laboratory.
    10. Have known (previously documented) 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.
    11. 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.
    12. Be undergoing treatment for acute or chronic hepatitis C.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of Participants With CMV Viremia Clearance (Clearance of Plasma CMV DNA)
    2. Number of Participants with Serious Adverse Events (SAE)
    3. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
    4. Number of Participants with Adverse Events Leading to Interruption with Maribavir
    5. Number of Participants with Adverse Events Leading to Permanent Treatment Discontinuation with Maribavir
    6. Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs
    7. Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings Reported as TEAEs
    8. Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters Reported as TEAEs
    9. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as TEAEs
    10. Immunosuppressant Drug Concentration Levels in Blood
    11. Number of Participants with TEAEs of New Onset of Acute or Chronic Graft-versus-host Disease (GVHD), Graft Rejection, or Graft Loss
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 20
    E.5.2Secondary end point(s)
    1. Percentage of Participants Who Maintained CMV Viremia Clearance and CMV Infection Symptom Control Achieved at the End of Study Week 8 Through Weeks 12, 16 and 20
    2. Time to First Confirmed CMV Viremia Clearance
    3. Percentage of Participants with Recurrence of Confirmed CMV Viremia during the 12-Week Follow-up Period in Participants with Confirmed CMV Viremia Clearance at Week 8 Requiring Additional Anti-CMV Treatment
    4. Change from Baseline in Plasma CMV Viremia Load
    5. Percentage of Participants with Recurrences of CMV Resistance Mutations after Maribavir Treatment
    6. Number of Kinds for CMV Genes Mutation Conferring Resistance to Maribavir after Maribavir Treatment
    7. Percentage of Participants who Achieved Confirmed Clearance at 137 IU/mL or Less of Plasma CMV DNA (CMV Viremia Clearance)
    8. Maribavir Minimum Concentration (Cmin)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to Week 20
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Being pediatric age group, participants were not able to give consent, thus needed parent/caregiver to sign consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 44
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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