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    Summary
    EudraCT Number:2019-003158-10
    Sponsor's Protocol Code Number:212358
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-27
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003158-10
    A.3Full title of the trial
    Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
    Długoterminowe badanie bezpieczeństwa i tolerancji lineriksybatu w leczeniu świądu cholestatycznego u pacjentów z pierwotnym zapaleniem dróg żółciowych.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Linerixibat Long-term Safety and Tolerability Study (LLSAT)
    Długoterminowe badanie bezpieczeństwa i tolerancji lineriksybatu (LLSAT)
    A.3.2Name or abbreviated title of the trial where available
    Long-term safety&tolerability of GSK2330672 as a treatment for cholestatic pruritus participants PBC
    A.4.1Sponsor's protocol code number212358
    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 SponsorGlaxoSmithKline Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 namelinerixibat (GSK2330672) 45mg
    D.3.2Product code GSK2330672
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinerixibat
    D.3.9.1CAS number 1345982-69-5
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB194569
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 namelinerixibat (GSK2330672) 40 mg
    D.3.2Product code GSK2330672
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinerixibat
    D.3.9.1CAS number 1345982-69-5
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB194569
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 namelinerixibat (GSK2330672) 45 mg
    D.3.2Product code GSK2330672
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinerixibat
    D.3.9.1CAS number 1345982-69-5
    D.3.9.2Current sponsor codeGSK2330672
    D.3.9.4EV Substance CodeSUB194569
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number45
    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
    Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Pruritus (itching) caused by primary biliary cholangitis (PBC)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level PT
    E.1.2Classification code 10064190
    E.1.2Term Cholestatic pruritus
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080429
    E.1.2Term Primary biliary cholangitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and tolerability of long-term linerixibat treatment in participants with cholestatic pruritus in PBC
    E.2.2Secondary objectives of the trial
    -To characterize the effects of long-term linerixibat treatment on disease
    burden and health related QOL in participants with
    cholestatic pruritus in PBC
    -To characterize the effects of long-term linerixibat treatment in
    participants with cholestatic pruritus in PBC
    For (Group 2: GLISTEN participants) Only
    -To evaluate the maintenance of efficacy of linerixibat on itch over 52
    weeks.
    -To evaluate the effect of linerixibat on health-related QoL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all the
    following criteria apply:
    Age
    1. Male or female participants must be 18 to 80 years of age inclusive, at
    the time of signing the informed consent in the participant's parent study
    BAT117213, GLIMMER or GLISTEN
    Note: if country/site age requirements for consent differ, the more
    stringent (e.g., higher age) restriction will be required for that country/site.
    Type of Participant and Disease Characteristics
    2. Participants with a diagnosis of PBC and a history of associated
    pruritus as evidenced by randomization into a prior eligible linerixibat
    clinical study(BAT117213, GLIMMER or GLISTEN)
    3. Participants must have completed the main treatment period(s) in a
    prior eligible linerixibat clinical study (BAT117213, GLIMMER or GLISTEN)
    Contraception requirements
    4.Contraceptive/Barrier Requirements (applicable for female
    participants only): A female participant is eligible to participate if she is
    not pregnant or breastfeeding, and one of the following conditions
    applies:
    o Is a woman of non-childbearing potential (WONCBP)
    OR
    o Is a woman of childbearing potential (WOCBP) and using an acceptable
    contraceptive method as described in Section 10.4 during the study
    intervention period (at a minimum until 4 weeks after the last dose of
    study intervention). The investigator should evaluate the potential for
    contraceptive method failure (e.g., noncompliance, recently initiated in
    relationship to the first dose of study intervention, etc.).
    -A WOCBP must have a negative highly sensitive urine pregnancy test
    (or serum, as required by local regulations) within 7 days before the first
    dose of study intervention, see Section 10.4 Pregnancy Testing.
    o If a urine test cannot be confirmed as negative (e.g., an ambiguous
    result), a serum pregnancy test is required. In such cases, the
    participant must be excluded from participation if the serum pregnancy
    result is positive
    • Additional requirements for pregnancy testing during and after study
    intervention are listed in Section 8.3.5 Pregnancy Testing and Section
    10.4 Appendix 4: Contraceptive Guidance and Collection of Pregnancy
    Information.
    • The investigator is responsible for review of medical history, menstrual
    history, and recent sexual activity to decrease the risk for inclusion of a
    woman with an early undetected pregnancy.
    Note: Contraceptive use by women should be consistent with local
    regulations regarding the methods of contraception for those
    participating in clinical studies.
    Full requirements for pregnancy testing during and after study
    intervention are located in Section 10.4 Appendix 4.
    Informed Consent
    5. Capable of giving signed informed consent as described in Appendix 1
    of protocol, which includes compliance with the requirements and
    restrictions listed in the informed consent form (ICF) and in this
    protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria
    apply:
    Medical Conditions
    1. Screening total bilirubin >2x ULN.
    Note: Total bilirubin >2x ULN but <3x ULN is acceptable if bilirubin is
    fractionated and direct bilirubin is <35%
    2. Screening ALT or aspartate aminotransferase (AST) >6x ULN
    3. Screening estimated glomerular filtration rate (eGFR) <30
    mL/min/1.73m² based on the Chronic Kidney Disease Epidemiology
    Collaboration (CKD-EPI) equation
    4. Group 2 Participants who meet increased liver chemistry monitoring
    criteria or any stopping criteria during LLSAT Screening period (GLISTEN
    Week 28 to Week 32 visit) or temporarily discontinue study treatment
    due to a drug-related adverse event
    during the LLSAT Screening period, which is ongoing before Baseline Visit.
    • Note: participants that meet increased liver chemistry monitoring
    criteria or stopping criteria at any timepoint during GLISTEN and restart
    of study intervention has not been approved by GSK are excluded
    5. Presence of hepatic decompensation (e.g., variceal
    bleeding, encephalopathy or ascites)
    6. Presence of actively replicating viral hepatitis B or C (HBV, HCV)
    infection,primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer
    7. Current clinically significant diarrhea in the Investigator's medical
    opinion
    8. Current symptomatic cholelithiasis or cholecystitis. Participants with
    history of cholecystectomy ≥3 months before screening may be eligible
    for enrollment
    9. Current diagnosis or previous diagnosis of colorectal cancer
    10. Any current malignancies (including hematologic and solid
    malignancies).
    11. History of bariatric surgery with ileal bypass at any time, or any
    bariatric surgery performed in the past 3 years.
    12. Any current medical condition (e.g. psychiatric disorder, senility or
    dementia), which may affect the participant's ability to comply with the
    protocol specified procedures
    Prior/Concomitant Therapy
    13. Use of Obeticholic acid: within 8 weeks prior to the date of the
    screening visit and may not restart until after the end of the study or early
    study withdrawal. [Rationale: The potential for a Drug-Drug Interaction
    (DDI) between obeticholic acid and linerixibat is under investigation. A
    DDI study assessing the concomitant use of OCA and 40 mg linerixibat
    twice daily is planned and depending on those results this OCA exclusion
    may be removed]
    14. Administration of any other IBAT inhibitor in the 1 month prior to
    screening until after End of Study or Early study withdrawal [Rationale:
    Effects of another IBAT inhibitor may confound interpretation of the
    linerixibat safety and tolerability profile]
    Prior/Concurrent Clinical Study Experience
    15. Current enrollment or participation in any other clinical study
    (except for GLISTEN)
    involving an investigational study treatment within 8 weeks prior to the
    screening visit
    Note: For participants coming from the GLISTEN study there is no
    specified waiting period before enrollment into this safety study.
    Diagnostic assessments
    16. QTc >480 msec at screening (12-lead ECG)
    NOTES: The QTc is the QT interval corrected for heart rate according to
    Bazett's formula (QTcB), Frederica's formula (QTcF), and/or another
    method. It is either machine-read or manually over-read
    The specific formula used to determine eligibility and discontinuation for
    an individual participant should be determined prior to initiation of the
    study and maintained for individual participants throughout study
    participation. The specific QT correction formula used must be specified
    in the eCRF
    The QT interval will be assessed at screening and at each long visit
    (yearly) by 12-Lead ECG. QTc stopping criteria are established for this
    study and are detailed in [Section 7.1.3] of Protocol
    Other Exclusions
    17. Participants with moderate (or greater) alcohol consumption defined
    as more than one standard drink per day for women and two drinks per
    day for men; whereby one standard drink is equivalent to: 12 oz beer
    (5% alcohol), 5 ounces of wine (12% alcohol), or 1.5 ounces of 80 proof
    spirits (40% alcohol).
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    From start of treatment (Day1) to end of study or until the follow up phone call after early study withdrawal (Day 7 to 14 post-final dose
    ofIP). Assessments are made on Day 1, Week 1, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30,
    Month 36, Month 42, Month 48 (Additional visits as needed) and final follow phone call on Day 7 to Day 14 post final dose of IP.
    E.5.2Secondary end point(s)
    1.Change in domain scores of the PBC-40 over time
    2.Change in the BDI-II over time
    3.Change in health-related QoL by the EQ-5D-3L summary index
    score(utility) over time (Group 1 participants only)
    4.Change in the EQ VAS (within the EQ-5D-3L) over time (Group 1
    participants only)
    5.Change in clinically meaningful laboratory values including liver
    parameters and lipids over time
    For (Group 2: GLISTEN participants) Only
    1.Responder (>2, >3 and >4 points reduction in MIS) at Week 24 of
    continuous treatment
    2.Responder (>2, >3 and >4 points reduction in MIS) at Week 52 of
    continuous treatment
    3.Maintenance of efficacy at Week 52 of continuous treatment in those
    that were responders at Week 24 of continuous treatment
    4.Change from Baseline in Monthly Sleep Score as measured by 0-10
    NRS over 52 weeks of continuous treatment
    5.Change from Baseline in Monthly Fatigue Score as measured by 0-10
    NRS over 52 weeks of continuous treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    For secondary endpoints numbers 1-4 the timepoints of evaluation are:
    From start of treatment (Day 1) until the final study visit (approximately Month 48 or longer as needed). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24,Month 30, Month 36, Month 42 and Month 48.


    For secondary endpoint number 5 the timepoints of evaluation are:
    From start of treatment (Day 1) until the final study visit (approximately Month 48). Assessments are made on Day 1, Month 3, Month 6, Month 9, Month 12, Month 24, Month 36 and Month 48.
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    Argentina
    Brazil
    Canada
    China
    Israel
    Japan
    Mexico
    United States
    Switzerland
    Russian Federation
    Bulgaria
    Czechia
    Greece
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In 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
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 295
    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 Decision2020-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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