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    Summary
    EudraCT Number:2016-001754-18
    Sponsor's Protocol Code Number:CLR_15_03
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-03-21
    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
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-001754-18
    A.3Full title of the trial
    A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706 in Healthy Subjects and in Subjects with Chronic Myeloid Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
    A.4.1Sponsor's protocol code numberCLR_15_03
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02629692
    A.5.4Other Identifiers
    Name:IND NumberNumber:127347
    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 SponsorSun Pharma Advanced Research Company (SPARC) Limited
    B.1.3.4CountryIndia
    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 supportSun Pharma Advanced Research Company (SPARC) Limited
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSun Pharma Advanced Research Company (SPARC) Limited
    B.5.2Functional name of contact pointSponsor representative - Chimote
    B.5.3 Address:
    B.5.3.1Street Address17/B Mahal Industrial Estate, Mahakali Caves Road Andheri (E)
    B.5.3.2Town/ cityMumbai
    B.5.3.3Post code400 093
    B.5.3.4CountryIndia
    B.5.4Telephone number+91 22 66455876
    B.5.5Fax number+91 22 66455685
    B.5.6E-mailgeetanjali.chimote@sparcmail.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 nameK0706
    D.3.2Product code K0706
    D.3.4Pharmaceutical form Capsule
    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 INNK0706
    D.3.9.2Current sponsor codeK0706
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number48
    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 nameK0706
    D.3.2Product code K0706
    D.3.4Pharmaceutical form Capsule
    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 INNK0706
    D.3.9.2Current sponsor codeK0706
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number24
    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 nameK0706
    D.3.2Product code K0706
    D.3.4Pharmaceutical form Capsule
    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 INNK0706
    D.3.9.2Current sponsor codeK0706
    D.3.9.3Other descriptive nameK0706
    D.3.9.4EV Substance CodeSUB184023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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
    Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
    E.1.1.1Medical condition in easily understood language
    leukemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009015
    E.1.2Term Chronic myeloid leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10034877
    E.1.2Term Philadelphia chromosome positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of Part B of the study are to:
    • Determine the MTD (or RP2D) of K0706 administered orally
    • Evaluate the safety of K0706

    The primary objective of Part C of the study are to:
    • Evaluate the anti-leukemic efficacy of K0706 in subjects with CML-CP by cytogenetic outcomes and in subjects with, AP and BP by hematologic outcomes who have failed ≥ 3 TKIs one of which includes ponatinib
    E.2.2Secondary objectives of the trial
    The secondary objectives of Part B of the study are to:
    • Evaluate the therapeutic activity of K0706
    • Evaluate the PK of K0706 after multiple oral doses in subjects with selected BCR-ABL-associated hamatologic malignancies

    The secondary objectives of Part C of the study are to evaluate:
    • Anti-leukemic efficacy of K0706 by molecular outcomes
    • Anti-leukemic efficacy of K0706 by hematological outcomes in CML-CP
    • Anti-leukemic efficacy of K0706 by cytogenetic outcomes in CML-AP & BP
    • Time to first hematologic response
    • Duration of response
    • Progression free survival (PFS) and Overall survival (OS)
    • Population PK of K0706
    • Safety of K0706 in the dosed subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part B:
    1.Willing and able to give written/signed, and dated, informed consent (or by legally acceptable representative/impartial witness when applicable - inclusion of subjects needing legally acceptable representative/impartial witness will be in compliance to the enrolling country’s regulatory requirement) and is available for the entire study
    2.Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions and be accessible for follow-up
    3.Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP, or Ph+ ALL who are refractory or intolerant to at least 3 TKIs or are not eligible (e.g.: due to comorbidities, hypersensitivity to excipients, lack of insurance coverage) for their local country’s regulatory approved and medically appropriate TKIs (e.g.: a TKI that is effective against mutations in the patient’s tumor)
    4.Male or female aged ≥ 18 years
    5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    6.Adequate organ and immune system function as indicated by the laboratory values obtained ≤ 2 weeks prior to IMP administration
    7.Subjects of childbearing potential must practice a medically acceptable method of birth control as judged by the Investigator (refer to protocol for details)
    8.Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an acceptable method as detailed in the Inclusion criteria # 7 and judged by the Investigator for the duration of the study and for 3 months after the last IMP administration
    9.Female subjects of childbearing potential must have a negative pregnancy test (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin).
    10.Female subjects must be non-lactating and non-breast-feeding

    Part C:
    1.Willing and able to give written/signed, and dated, informed consent (or by legally acceptable representative/impartial witness when applicable- inclusion of subjects needing legally acceptable representative/impartial witness will be in compliance to the enrolling country’s regulatory requirement) and is available for the entire study
    2.Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions, and be accessible for follow-up
    3.Subjects with Ph+CML CP, AP or BP who are resistant and/or intolerant to ≥ 3 prior TKIs one of which includes ponatinib. (Subjects with Ph+ ALL are not included)
    4.Male or female aged ≥ 18 years
    5.Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
    6.Adequate organ and immune system function as indicated by the following laboratory values obtained ≤ 2 weeks prior to IMP administration.
    7.Subjects of childbearing potential must practice a medically acceptable method of birth control as judged by the Investigator (refer to protocol for details)
    8.Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an acceptable method as detailed in the Inclusion criteria # 7 and judged by the Investigator for the duration of the study and for 3 months after the last IMP administration
    9.Female subjects of childbearing potential must have a negative pregnancy test (as confirmed by a negative urine pregnancy test with a sensitivity of less than 50 mIU/mL or equivalent units of human chorionic gonadotropin).
    10.Female subjects must be non-lactating and non-breast-feeding
    E.4Principal exclusion criteria
    Part B:
    1.Presence of T315I mutations
    2.Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
    3.Inability to swallow oral medication
    4.Inability to undergo venipuncture and/or tolerate venous access
    5.Evidence of clinically significant organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical laboratory test findings as per the Investigator’s discretion
    6.Positive tests: urine pregnancy tests (if applicable), HIV
    7.History of any relevant allergy/hypersensitivity (including known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or its excipients)
    8.Known history of active hepatitis B or hepatitis C
    9.Received any other investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer, of IMP administration
    10.Use of concomitant medication that might influence the results of the study prior to IMP administration and/or anticipated need at any time during the study
    11.Known or suspected history of significant drug abuse as judged by the Investigator
    12.Known or suspected history of alcohol abuse or excessive intake of alcohol in the 12 months prior to study entry
    14.Radiotherapy or cytotoxic chemotherapy within 21 days or Vincristine within 7 days (for Ph+ ALL only); interferon or Cytarabine or immunotherapy within 14 days prior to the first IMP administration visit
    15.Malabsorption syndrome or other illness that could affect oral absorption of the IMP
    16.Clinically significant, uncontrolled, or active cardiovascular disease
    17.Uncontrolled intercurrent illness
    18.Subjects eligible and willing to undergo transplant
    20.Autologous or allogeneic stem cell transplant ≤ 3 months prior to Screening
    Other criteria may apply (refer to protocol)

    Part C:
    1.Presence of T315I mutations
    2.Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration
    3.Inability to swallow oral medication
    5.Evidence of clinically significant organ dysfunction or any clinically relevant deviation from normal in physical examination, ECG findings, vital signs, or clinical laboratory test findings which in the opinion of the investigator may jeopardize the safety of the patient during the study or may interfere with the evaluation of the study medication.
    6.Positive tests: urine pregnancy tests (if applicable), HIV
    7.History of any relevant allergy/hypersensitivity (including known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the IMP or its excipients)
    8.Known history of active hepatitis B or hepatitis C
    9.Received an investigational agent within 30 days or a washout of at least 5 half-lives, whichever is longer of IMP administration
    10.Use of concomitant medication that might influence the results of the study prior to IMP administration/or anticipated need any time during the study
    11.Known or suspected history of alcohol abuse or excessive intake of alcohol in the 12 months prior to study entry
    12.Known or suspected history of significant drug abuse as judged by the Investigator
    14.Radiotherapy or cytotoxic chemotherapy within 21 days or Vincristine within 7 days (for Ph+ ALL only); interferon or Cytarabine or immunotherapy within 14 days prior to the first IMP administration visit
    15.Active central nervous system (CNS) disease as evidenced by cytology or pathology.
    16.Malabsorption syndrome or other illness that could affect oral absorption of the IMP
    18.Clinically significant, uncontrolled, or active cardiovascular disease
    19.Uncontrolled intercurrent illness
    20.Subjects eligible and willing to undergo bone marrow transplant
    21.Autologous or allogeneic stem cell transplant ≤ 3 months prior to Screening
    22.Another primary malignancy within the past 3 years or earlier.
    23.Any contraindications for repeated bone marrow sample collection
    24.Prior exposure to K0706 therapy as a participant in Part B of the protocol
    Other criteria may apply (refer to protocol)
    E.5 End points
    E.5.1Primary end point(s)
    Part B
    The primary endpoint will be the MTD as determined by the frequency of DLTs
    The safety endpoint will be AEs assessed based on the NCI CTCAE v4.03, ECOG performance status, vital signs, ECG, clinical laboratory values, and physical examination

    Part C
    •Cohort A: For CML subjects in CP at study entry: Major Cytogenetic Response (MCyR), defined as complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR).
    CP subjects in CCyR are not eligible for this study.

    •Cohort B: For CML subjects in AP at study entry: Major Hematologic Response (MaHR), defined as complete hematologic response (CHR) or no evidence of leukemia (NEL).
    AP subjects in MaHR are not eligible for this study.

    •Cohort C: For CML subjects in BP at study entry: MaHR, consisting of CHR or NEL. BP subjects in MaHR are not eligible for this study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    throghout the study duration
    E.5.2Secondary end point(s)
    Part B:
    • Anti-leukemic response assessment following the assessments following the hematological, cytogenetic and molecular assessments
    The PK endpoints will be:
    • Cmax, tmax, CL/F (for Cycle 2), AUC(0 tau), AUC(0 tau)/dose, Cmax/dose, Vz/F, and accumulation ratios for AUC and Cmax
    • Ctrough

    Part C:
    • In subjects with CML-CP
    - Hematological responses: Proportion of subjects who achieve or maintain complete hematological response
    - Cytogenetic response: Proportion of subjects who achieve CCyR
    - Molecular responses: Proportion of subjects who achieve or maintain MMR
    • In subjects with CML-AP or CML-BP
    - Cytogenetic responses: Proportion of subjects who achieve CCyR, PCyR
    - Molecular responses: Proportion of subjects who achieve MMR
    • In all subjects: Safety and tolerability in terms of incidence and severity of treatment emergent AEs
    • In all subjects: Time to response, duration of response, PFS and OS
    E.5.2.1Timepoint(s) of evaluation of this end point
    For efficacy outcome: throghout the study duration
    For PK:
    - Day 1 of Cycle 1: Predose, 0.5, 1, 2, 2.5, 4, 8, 24 hours (i.e., Day 2) postdose.
    - Days 3, 8, 15, and 22 of Cycle 1: Predose only.
    - Day 1 of Cycle 2 (Day 29 from start of treatment): Predose, 0.5, 1, 2, 2.5, 4, 8, 24 hours (i.e., Day 30) postdose.
    - Days 8, 15, and 22 of Cycle 2: Predose only.
    - Subsequent cycles: Predose samples on Day 1.

    For Part C: throghout the study duration
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Part B: to determine the MTD/RP2D; Part C: to evaluate the anti-leukemic efficacy
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Belgium
    France
    Germany
    Hungary
    India
    Italy
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Thailand
    Turkey
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    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) Yes
    F.1.2.1Number of subjects for this age range: 116
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 139
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 119
    F.4.2.2In the whole clinical trial 255
    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)
    After a subject has completed the study or has withdrawn early from the study, usual treatment (as per the local standards of care) will be administered, if required, in accordance with the study center’s generally accepted medical practice and depending on the subject’s individual medical needs. The Sponsor will not have any role to play in further treatment and the treatment regimen followed will be outside the purview of the study protocol.
    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 Decision2017-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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