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    Summary
    EudraCT Number:2018-001331-48
    Sponsor's Protocol Code Number:D9481C00001
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-22
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2018-001331-48
    A.3Full title of the trial
    A Phase 3, Dose-Escalating Study in Children With Hyperkalaemia Between Birth and <18 Years of Age to Evaluate Increasing Doses of Sodium Zirconium Cyclosilicate (SZC) Given Three Times Daily for the Correction of Hyperkalaemia and the Effectiveness of the Same Dose of SZC Given Once Daily to Maintain Normokalaemia Among Those Requiring Continuous Treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate increasing doses of Sodium Zirconium Cycloscilicate (SZC) in children under 18 years old who have high blood potassium levels (Hyperkalaemia ). Patients will take SZC each day (in one or three doses), until normal blood potassium levels are reached (Normokalaemia)
    A.4.1Sponsor's protocol code numberD9481C00001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/053/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformation.center@astrazeneca.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 nameSodium zirconium cyclosilicate
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNNot assigned
    D.3.9.1CAS number 242800-27-7
    D.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Yes
    D.2.1.1.1Trade name Lokelma 5 g powder for oral suspension
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje, Sweden
    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 nameSodium zirconium cyclosilicate
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNNot assigned
    D.3.9.1CAS number 242800-27-7
    D.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 nameSodium zirconium cyclosilicate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNNot assigned
    D.3.9.1CAS number 242800-27-7
    D.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 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 nameSodium zirconium cyclosilicate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Yes
    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 INNNot assigned
    D.3.9.1CAS number 242800-27-7
    D.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.125
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for oral solution in sachet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hyperkalaemia
    E.1.1.1Medical condition in easily understood language
    High blood potassium
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10020647
    E.1.2Term Hyperkalemia
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    28-day maintenance phase (MP) primary objective: To compare the effect of SZC vs placebo on maintaining normokalaemia during the MP

    Correction phase (CP) primary objective: To evaluate SZC dose levels on achieving normokalaemia during the CP
    E.2.2Secondary objectives of the trial
    CP secondary objectives evaluate SZC dose levels on the following:
    achieving normokalaemia within the first 72 hours
    time to achieving normokalaemia during the CP
    the reduction of serum K levels during the CP
    time to reduction of serum K levels during the CP
    MP secondary objectives evaluate SZC vs placebo on the following:
    time from randomization to relapse of hyperkalaemia
    the proportion of subjects with normokalaemia per visit over the MP
    the change in serum K levels over the MP
    time to increase in serum K during the MP
    proportion of days of normokalaemia during the MP
    mean serum K during the MP
    proportion of subjects experiencing hypo- or hyperkalaemia during the MP
    serum aldosterone at end of the MP
    plasma electrolytes (including bicarbonate) and spot urinary pH and electrolytes
    Long term maintenance phase(LTMP)objective:To evaluate long term maintenance of normokalemia during treatment with SZC
    Acceptability and palatability of SZC is evaluated in all study phases
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent of the subject or legal representative, and informed assent from the subject (as appropriate)
    2. Female or male from birth to <18 years of age.
    3. Subjects requiring long term treatment of hyperkalaemia (chronic hyperkalaemia) in the age cohort ≥2 years, and subjects requiring either short- or long-term treatment for hyperkalaemia (acute and chronic hyperkalaemia) in the age cohort <2 years.
    4. Subjects must meet 1 of the following criteria for hyperkalaemia:
    (a) For subjects ≥2 years of age, mean i STAT K level >5.0 mmol/L at Screening. Two consecutive i STAT K values, measured 60 (±15) minutes apart, both ≥5.0 mmol/L and measured within 1 day before the first dose of SZC on CP Study Day 1.
    (b) For subjects <2 years of age, i STAT K level >6.0 mmol/L at Screening, measured within 1 day before the first dose of SZC on CP Study Day 1.
    5. Using digital ECG, QT interval corrected by Bazett's method (QTcB) must meet the age-appropriate parameters at Screening:
    (a) For subjects aged 0 to ≤3 days after birth: <450 ms
    (b) For subjects aged >3 days to <12 years: <440 ms
    (c) For subjects ≥12 to <18 years: <450 ms (male), <460 ms (female)
    All QTcB values outside the reference values specified in the protocol should be manually re-measured and re-calculated, and if there is a difference in measurement between the automatic and manual ECG, the manual measurement should always be considered correct.
    6. Ability to have repeated blood draws or effective venous catheterization.
    7. Females of childbearing potential must have a negative pregnancy test within 1 day prior to the first dose of SZC on CP Study Day 1 and sexually active females of childbearing potential must be using 2 forms of medically acceptable contraception with at least 1 being a barrier method
    E.4Principal exclusion criteria
    1. Neonates with a gestational age <30 weeks or a birth weight <1500 g.
    2. Subjects with pseudohyperkalaemia caused by excessive fist clenching to enable venepuncture, by haemolysed blood specimens, or by severe leukocytosis or thrombocytosis.
    3. Subjects with hyperkalaemia due to soft-tissue damage from crush injury or burns.
    4. Subjects treated with lactulose, rifaximin (XIFAXAN™), or other nonabsorbed antibiotics for hyperammonaemia within the last 7 days.
    5. Subjects treated with calcium polystyrene sulfonate (CPS), sodium polystyrene sulfonate (e.g., KAYEXALATE™), or patiromer within the last 4 days.
    6. Subjects with a life expectancy of less than 3 months.
    7. Subjects who are known to have tested Human Immunodeficiency Virus (HIV) positive.
    8. Presence of any condition which, in the opinion of the Investigator, places the subject at undue risk or potentially jeopardises the quality of the data to be generated.
    9. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof.
    10. Subjects with cardiac arrhythmias that require immediate treatment.
    11. Subjects with a family history of long QT syndrome.
    12. Subjects on dialysis to exclude subjects requiring acute or chronic renal replacement therapy.
    13. Subjects with a history of bowel obstruction.
    14. Subjects with severe gastrointestinal disorder or major gastrointestinal surgery (e.g., large bowel resection).
    15. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    16. Previous treatment with SZC.
    17. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
    18. Previous enrolment in the present study.
    19. Females who are pregnant, breastfeeding, or planning to become pregnant.
    20. Judgment by the Investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
    E.5 End points
    E.5.1Primary end point(s)
    28-day maintenance phase (MP) primary endpoint (primary analysis endpoint):
    The proportion of subjects in whom normokalaemia can be maintained throughout the MP
    Correction phase (CP) primary endpoint:
    The proportion of subjects in whom serum K decreases by ≥0.5 mmol/L and who achieve normokalaemia at (by or before) 24, 48 and 72 hours during CP.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Correction Phase 24, 48 and 72 hours
    Maintenance Phase 28 days
    E.5.2Secondary end point(s)
    CP secondary endpoints:
    - The proportion of subjects in whom serum K decreases by ≥0.5 mmol/L and who achieve normokalaemia during the first 72 hours
    - Time to first day achievement of normokalaemia
    - Absolute and percent change from baseline in serum K levels at all intervals of follow-up after dosing has been initiated
    - Time to decrease of 0.5 mmol/L in serum K level
    - Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)
    MP secondary endpoints:
    - Time from randomization to relapse of hyperkalaemia (return to serum K level >5.0 mmol/L for subjects 2 to <18 years and >6.0 mmol/L for subjects <2 years) in each treatment group
    - Proportion of subjects within each treatment group who maintain normal serum K levels (defined as serum K of ≥3.5 mmol/L and ≤5.0 mmol/L for subjects aged 2 to <18 years and serum K of ≥3.5 mmol/L and ≤6.0 mmol/L for subjects <2 years) per visit over the MP
    - Both absolute and percent change from baseline in serum K levels post dose during the MP and at any time point thereafter in each treatment group
    - Time to an increase in serum K concentration of 0.5 mmol/L in each treatment group
    - Number and percentage of days of normokalaemia
    - The difference in mean of all serum K values obtained during the MP in subjects receiving either SZC or placebo
    - The number and percentage of subjects with hypo- (<3.0 mmol/L) or hyperkalaemia (>6.0 mmol/L) in subjects receiving either SZC or placebo
    - Change from baseline in serum aldosterone (S Aldo) to end of the MP
    - Change from baseline in plasma electrolytes (including bicarbonate) and spot urinary pH and electrolytes to end of the MP
    - Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)
    LTMP secondary endpoints:
    - Proportion of subjects in whom normokalaemia can be maintained over the LTMP
    - Proportion of subjects who needed dose escalation to higher dose levels during the LTMP
    - Proportion of subjects who needed dose de-escalation to lower dose levels during the LTMP
    - The number and percentage of subjects with hypo- (<3.0 mmol/L) or hyperkalaemia (>6.0 mmol/L) during the LTMP
    - Proportion of patients per response category in Study Medication Palatability Assessment questionnaires (self reported or observer assessment)
    E.5.2.1Timepoint(s) of evaluation of this end point
    CP secondary endpoints:
    - 24, 48, 72 hours
    - 24, 48, 72 hours
    - 24, 48, 72 hours
    - 24, 48, 72 hours
    - Day 1 and 3
    MP secondary endpoints:
    - MP Endpoints 1-7 Days 1, 7, 14, 21, 28
    - Days 1 & 21
    - Days 1 & 21
    - Days 7 & 28
    LTMP secondary endpoints:
    - Days 28, 57, 85, 113, 141, 183
    - Days 28, 57, 85, 113, 141, 183
    - Days 28, 57, 85, 113, 141, 183
    - Days 28, 57, 85, 113, 141, 183
    - Day 28 & 183
    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 No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose-escalation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Canada
    Germany
    Italy
    Poland
    Romania
    Russian Federation
    South Africa
    Ukraine
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 1
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 49
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 39
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 100
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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