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    Summary
    EudraCT Number:2019-002621-30
    Sponsor's Protocol Code Number:M19-063
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-002621-30
    A.3Full title of the trial
    A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label 2-Arm Study of Venetoclax in Combination with Azacitidine Versus Best Supportive Care after Allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML)
    A.3.2Name or abbreviated title of the trial where available
    P3 Ven+Aza vs BSC in AML post allogneneic stem cell transplant
    A.4.1Sponsor's protocol code numberM19-063
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointGlobal Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbvie House, Vanwall Business Park
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-mailglobal-clinical-trials@abbvie.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 nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    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 INNVenetoclax 10 mg
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    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 nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    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 INNVenetoclax 50 mg
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    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 nameVenetoclax
    D.3.2Product code ABT-199 (GDC-0199)
    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 INNVenetoclax 100 mg
    D.3.9.2Current sponsor codeABT-199 (GDC-0199)
    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 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.IMP: 4
    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 Yes
    D.2.1.1.1Trade name Azacitidine Accord
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare S.L.U.
    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 nameAzacitidine
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzacitidine
    D.3.9.1CAS number 320-67-2
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive nameVidaza
    D.3.9.4EV Substance CodeSUB05624MIG
    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 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
    Acute Myeloid Leukemia (AML)
    E.1.1.1Medical condition in easily understood language
    Hematologic Malignancies
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part I: To determine the recommended Phase 3 dose of venetoclax in combination with azacitidine in AML patients when given as maintenance therapy following allogeneic SCT.

    Part II:To evaluate the efficacy of venetoclax in combination with azacitidine to improve OS in AML patients compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation
    E.2.2Secondary objectives of the trial
    Part 2:
    *To confirm the safety of venetoclax in combination with azacitidine after allogeneic transplantation in subjects diagnosed with AML.
    *To determine the efficacy of venetoclax in combination with azacitidine as measured by RFS.
    *To determine the efficacy of venetoclax in combination with azacitidine on the frequency and severity of GvHD.
    *To determine the effect of venetoclax in combination with azacitidine on Quality of Life (QoL).
    *To determine the effect of venetoclax in combination with azacitidine on minimal residual disease levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult male or female ≥ 18 years old for Part 1 and, male or female at least 12 years old for Part 2.
    Subject must be diagnosed with AML by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days.
    Blast percentage in bone marrow prior to pre-transplant conditioning must be < 10%.
    Blast count in peripheral blood must be “0” and malignant Blast percentage in bone marrow must be < 5% after transplant within 7 days prior to Cycle 1 Day 1.
    Bilirubin ≤3 × ULN* within 7 days prior to Cycle 1 Day 1
    For Part 1: ANC ≥1,500/µL, measured twice at least 2 days apart (approximately 48 hours) and within 1 week prior to Cycle 1 Day 1.
    Subjects should not have granulocyte-colony stimulating factor (G-CSF) treatment for 7 days before first ANC count.
    For Part 2: ANC ≥1,000/µL, measured twice at least 2 days apart (approximately 48 hours) and within 1 week prior to Cycle 1 Day 1 or prior to dosing on Cycle 1 Day 1. Subjects should not have granulocyte-colony stimulating factor (G-CSF) treatment for 7 days before first ANC count.
    Part 1: Platelet count ≥80,000/µL measured twice at least 2 days apart (approximately 48 hours) and within 1 week prior to Cycle 1 Day 1.
    Subjects should not have supportive treatment (e.g., transfusions and/or growth factors) for 7 days before first platelet count.
    Part 2: Platelet count ≥50,000/µL measured twice at least 2 days apart (approximately 48 hours) and within 1 week prior to Cycle 1 Day 1 or prior to dosing on Cycle 1 Day 1. Subjects should not have supportive treatment (e.g., transfusions and/or growth factors) for 7 days before first platelet count.
    Adequate renal function as demonstrated by a creatinine clearance > 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.

    Subjects ≥17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and Subjects 12 to 16 years old must have a Lansky Play-Performance Scale (LPPS) score > 40.
    Part 2: If a subject is 12 to 16 at the time of screening and turns 17 during the study, the subject will continue with the LPPS.
    Cycle 1 Day 1 administration of 1st dose of the study drug(s) must occur within 28 to 100 days after transplant. Subjects may enter into Screening upon the first instance of meeting the count recovery criteria without the need for supportive care (e.g., growth factors and/or platelet transfusions) for at least 7 days prior. Upon entering screening, subjects must maintain count thresholds on at least 2 occasions (approximately 48 hours apart) in the absence of supportive care (platelet transfusion/G-CSF within 7 days).
    If graft failure occurs during the registration period and a subsequent transplant is planned, the subject can be reconsented for the study.
    (Notes a - b):
    a) C1D1 must occur within 28 to 100 days of this subsequent transplant date.
    b) If there is a subsequent (second) graft failure after reconsent during the registration period, the subject will not be permitted to enroll into the study.

    No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
    E.4Principal exclusion criteria
    Subjects with favorable cytogenetic risk per NCCN 2016 criteria and in first complete remission prior to transplant are not eligible to enroll in this study.
    History of disease progression during prior treatment with venetoclax.
    History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome; Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation).
    Known infection with HIV or subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV) with high viral titers.
    Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.
    E.5 End points
    E.5.1Primary end point(s)
    Part I: The primary endpoint is the frequency of DLTs of venetoclax in combination with azacitidine
    Part II: OS defined as the time from randomization to death from any cause
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part I: The primary endpoint is the frequency of DLTs of venetoclax in combination with azacitidine
    Part II: OS defined as the time from randomization to death from any cause


    E.5.2Secondary end point(s)
    • IRC-assessed morphologic RFS
    • IRC-assessed composite relapse-free survival

    • GvHD-free, relapse free survival (GRFS).
    • GvHD rate at 90 days after randomization (Arm B) or initiation of treatment (Arm A)
    "Higher grade GvHD" is defined as Grade 2 or higher for aGvHD and moderate or severe for cGvHD as defined by the investigator following National Institutes of Health (NIH) criteria.
    - Change from baseline (Cycle 1 Day 1 [predose]) at 6 months in physical functioning after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects, as measured by the EORTC QLQ-C30 physical functioning domain
    • Fatigue Change from baseline at 6 months after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects - defined as Fatigue measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a
    - Measurable residual disease conversion rate - The rate will be calculated only among subjects with MRD ≥10-3 at baseline (Cycle 1 Day 1 [predose]). The MRD conversion rate will be defined as proportion of subjects who convert to MRD < 10-3 after randomization (Arm B) or initiation of treatment (Arm A)
    - Time to deterioration in Global Health Status (GHS)/QoL in adult subjects - defined as time from randomization to death from any cause, or the first-time deterioration of ≥10 points from baseline (Cycle 1 Day 1 [predose]) in GHS/QoL score as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Version 3, whichever occurs first.
    E.5.2.1Timepoint(s) of evaluation of this end point
    IRC-assessed morphologic RFS (morphologic relapse or death)
    IRC-assessed composite relapse-free survival (morphologic relapse from AML, non-morphologic relapse,or death)
    GvHD-free,relapse free survival(GRFS)-time from randomization to disease relapse, incidence of GvHD, or death(any reason)
    GvHD rate at 90 days after randomization-Grade 2 or higher for aGvHD and moderate/severe for cGvHD per investigator
    Fatigue Change in adult subjects using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.
    Difference between randomization and 6 months after randomization (Arm B) or initiation of study treatment (Arm A)
    Measurable residual disease conversion rate measured as described in Secondary Endpoints

    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best Supportive Care (BSC)
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Switzerland
    Taiwan
    Australia
    Brazil
    Canada
    China
    Czechia
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Spain
    United Kingdom
    United States
    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
    Last subject's last visit or date of the last follow-up contact, whichever is later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 32
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 305
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 424
    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)
    If a subject prematurely discontinues the study (withdrawal of informed consent), The procedures outlined for the end of treatment visit are to be completed as soon as possible, preferably within 2 weeks. In addition, if subject is willing, a 30-day follow-up phone call after the last dose of study drug for subjects in Part 1 and Part 2, Arm A or after study withdrawal for subjects in Part 2, Arm B may be completed to ensure all treatment-emergent AEs/SAEs have been resolved.
    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 Decision2020-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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