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    Summary
    EudraCT Number:2019-000413-36
    Sponsor's Protocol Code Number:BGB-3111-306
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000413-36
    A.3Full title of the trial
    A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus Bendamustine plus Rituximab in Patients with Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
    Studio di fase III randomizzato, in aperto, multicentrico, volto a confrontare zanubrutinib (BGB-3111) più rituximab rispetto a bendamustina più rituximab in pazienti affetti da linfoma mantellare non trattato in precedenza non idonei al trapianto di cellule staminali
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus
    Bendamustine plus Rituximab in Patients with Previously Untreated Mantle
    Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
    Study Comparing Zanubrutinib (BGB-3111) plus Rituximab Versus
    Bendamustine plus Rituximab in Patients with Previously Untreated Mantle
    Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
    A.3.2Name or abbreviated title of the trial where available
    N.A.
    N.A.
    A.4.1Sponsor's protocol code numberBGB-3111-306
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04002297
    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 SponsorBeiGene Ltd.
    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 supportBeiGene, Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene, Ltd.
    B.5.2Functional name of contact pointUS
    B.5.3 Address:
    B.5.3.1Street AddressUS
    B.5.3.2Town/ cityUS
    B.5.3.3Post codeUS
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@beigene.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameZanubrutinib
    D.3.2Product code [BGB-3111]
    D.3.4Pharmaceutical form Capsule, hard
    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 INNZANUBRUTINIB
    D.3.9.1CAS number 1691249-45-2
    D.3.9.2Current sponsor codeBGB-3111
    D.3.9.4EV Substance CodeSUB184615
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Levact PA 731/5/2
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLevact
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBENDAMUSTINA CLORIDRATO
    D.3.9.1CAS number 3543-75-7
    D.3.9.2Current sponsor codeN.A.
    D.3.9.4EV Substance CodeSUB00696MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name MabThera EU/1/98/067/001
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMabThera 100mg
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeN.A.
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name MabThera EU/1/98/067/002
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMabThera 500mg
    D.3.2Product code [N.A.]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.2Current sponsor codeN.A.
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Mantle Cell Lymphoma
    linfoma mantellare
    E.1.1.1Medical condition in easily understood language
    Mantle Cell Lymphoma
    linfoma mantellare
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare efficacy, as measured by progression-free survival (PFS)
    determined by independent central review
    Confrontare l’efficacia, misurata mediante la sopravvivenza libera da progressione (Progression-Free Survival, PFS) determinata tramite revisione centrale indipendente
    E.2.2Secondary objectives of the trial
    Secondary:
    • To evaluate efficacy, as measured by the following:
    - Progression-free survival determined by investigator assessment
    - Overall response rate (ORR), as determined by independent
    central review and by investigator assessment
    - Duration of response (DOR), as determined by independent
    central review and by investigator assessment
    - Overall survival (OS)
    - Rate of complete response (CR) or complete metabolic response
    determined by independent central review and by investigator
    assessment
    - Time to response, as determined by independent central review
    and by investigator assessment
    - Patient reported outcomes
    - To evaluate safety and tolerability
    Secondari:
    • Valutare l’efficacia, misurata mediante quanto indicato di seguito:
    - Sopravvivenza libera da progressione, determinata mediante valutazione dello sperimentatore;
    - Tasso di risposta complessiva (Overall Response Rate, ORR), determinato mediante revisione centrale indipendente e valutazione dello sperimentatore;
    - Durata della risposta (Duration of Response, DOR), determinata mediante revisione centrale indipendente e valutazione dello sperimentatore;
    - Sopravvivenza complessiva (Overall Survival, OS);
    - Tasso di risposta completa (Complete Response, CR) o di risposta metabolica completa, determinato mediante revisione centrale indipendente e valutazione dello sperimentatore;
    - Tempo alla risposta, determinato mediante revisione centrale indipendente e valutazione dello sperimentatore;
    - Esiti riferiti dai pazienti.
    - Valutare la sicurezza e la tollerabilità.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • = 70 years of age at the time of informed consent, OR
    • 65-69 years of age with comorbidities precluding autologous stem cell
    transplantation
    • Histologically confirmed diagnosis of MCL
    • No prior systemic treatments for MCL
    • Measurable disease by CT/MRI
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • Adequate marrow and organ function
    • = 70 years of age at the time of informed consent, OR
    • 65-69 years of age with comorbidities precluding autologous stem cell
    transplantation
    • Histologically confirmed diagnosis of MCL
    • No prior systemic treatments for MCL
    • Measurable disease by CT/MRI
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • Adequate marrow and organ function
    E.4Principal exclusion criteria
    • Known central nervous system involvement by lymphoma
    • Patients for whom the goal of therapy is tumor debulking prior to stem
    cell transplant
    • Clinically significant cardiovascular disease
    • History of severe bleeding disorder
    • Unable to swallow capsules or disease significantly affecting
    gastrointestinal function
    • Active fungal, bacterial and/or viral infection requiring systemic
    therapy
    • Requires ongoing treatment with a strong CYP3A inhibitor or inducer
    • Known central nervous system involvement by lymphoma
    • Patients for whom the goal of therapy is tumor debulking prior to stem
    cell transplant
    • Clinically significant cardiovascular disease
    • History of severe bleeding disorder
    • Unable to swallow capsules or disease significantly affecting
    gastrointestinal function
    • Active fungal, bacterial and/or viral infection requiring systemic
    therapy
    • Requires ongoing treatment with a strong CYP3A inhibitor or inducer
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS as determined by independent central
    review using the Lugano Classification for NHL and defined as the time
    from randomization to the date of first documentation of disease
    progression or death, whichever occurs first.
    The primary endpoint is PFS as determined by independent central
    review using the Lugano Classification for NHL and defined as the time
    from randomization to the date of first documentation of disease
    progression or death, whichever occurs first.
    E.5.1.1Timepoint(s) of evaluation of this end point
    date of first documentation of disease progression or death, whichever
    occurs first
    date of first documentation of disease progression or death, whichever
    occurs first
    E.5.2Secondary end point(s)
    • Progression-free survival as determined by investigator assessment
    using the Lugano Classification for NHL, and defined as the time from
    randomization to the date of first documentation of disease progression
    or death, whichever occurs first
    • Overall response rate, defined as the proportion of patients who
    achieve a CR or partial response (PR), determined by independent
    central review and by investigator assessment
    • Duration of response, as determined by independent central review
    and by investigator assessment, and defined as the time from the date
    that response criteria are first met to the date that disease progression
    is objectively documented or death, whichever occurs first
    • Overall survival, defined as the time from randomization to the date of
    death due to any reason
    • Rate of CR or complete metabolic response, defined as the proportion
    of patients who achieve a CR or complete metabolic response,
    determined by independent central review and by investigator
    assessment
    • Time to response, as determined by independent central review and by
    investigator assessment, and defined as time from randomization to the
    first documentation of response
    • Patient-reported outcomes as measured by the EQ-5D-5L and EORTC
    QLQ-C30 questionnaires
    • Safety parameters, including AEs, SAEs, clinical laboratory tests,
    physical exams, and vital signs
    • Progression-free survival as determined by investigator assessment
    using the Lugano Classification for NHL, and defined as the time from
    randomization to the date of first documentation of disease progression
    or death, whichever occurs first
    • Overall response rate, defined as the proportion of patients who
    achieve a CR or partial response (PR), determined by independent
    central review and by investigator assessment
    • Duration of response, as determined by independent central review
    and by investigator assessment, and defined as the time from the date
    that response criteria are first met to the date that disease progression
    is objectively documented or death, whichever occurs first
    • Overall survival, defined as the time from randomization to the date of
    death due to any reason
    • Rate of CR or complete metabolic response, defined as the proportion
    of patients who achieve a CR or complete metabolic response,
    determined by independent central review and by investigator
    assessment
    • Time to response, as determined by independent central review and by
    investigator assessment, and defined as time from randomization to the
    first documentation of response
    • Patient-reported outcomes as measured by the EQ-5D-5L and EORTC
    QLQ-C30 questionnaires
    • Safety parameters, including AEs, SAEs, clinical laboratory tests,
    physical exams, and vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    all of the secondary endpoints except last two have defined timepoints
    included above. In an addition PRO's are measured at every visit during
    treatment. Safety parameters are measured at every visit.
    Adverse events will be reported until 30 days after the last dose of
    zanubrutinib or bendamustine, or until 90 days after the last dose of
    rituximab, whichever occurs later.
    all of the secondary endpoints except last two have defined timepoints
    included above. In an addition PRO's are measured at every visit during
    treatment. Safety parameters are measured at every visit.
    Adverse events will be reported until 30 days after the last dose of
    zanubrutinib or bendamustine, or until 90 days after the last dose of
    rituximab, whichever occurs later.
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA74
    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 Information not present in EudraCT
    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
    Canada
    China
    Japan
    New Zealand
    Russian Federation
    Taiwan
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Denmark
    France
    Germany
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Romania
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months9
    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 No
    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) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 500
    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)
    N.A
    N.A
    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 Decision2020-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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