Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-001579-35
    Sponsor's Protocol Code Number:KBP5074-2-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-06-17
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-001579-35
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Pharmacokinetics of KBP-5074 in Patients with Moderate-to-Severe Chronic Kidney Disease and Uncontrolled Hypertension – (BLOCK/CKD)
    2. fázisú randomizált, kettős vak, placebokontrollos, multicentrikus vizsgálat a KBP-5074 hatásosságának, biztonságosságának és farmakokinetikájának értékelésére közepesen súlyos vagy súlyos krónikus vesebetegségben és nem kontrollált hipertóniában szenvedő betegeknél (BLOCK/CKD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy, safety and pharmacokinetics of KBP-5074 in patients with chronic kidney disease and uncontrolled hypertension
    A.3.2Name or abbreviated title of the trial where available
    BLOCK/CKD
    A.4.1Sponsor's protocol code numberKBP5074-2-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03574363
    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 SponsorKBP BioSciences Co., Ltd.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKBP BioSciences Co., Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKBP BioSciences Co., Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address116 Village Blvd, Suite 210
    B.5.3.2Town/ cityPrinceton, NJ
    B.5.3.3Post code08540
    B.5.3.4CountryUnited States
    B.5.4Telephone number001267-799-6545
    B.5.6E-mailvince.benn@kbpbiosciences.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 nameKBP-5074
    D.3.2Product code KBP-5074
    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 INNKBP-5074
    D.3.9.1CAS number 1359969-24-6
    D.3.9.2Current sponsor codeKBP-5074
    D.3.9.3Other descriptive name2-chloro-4-[(3S,3aR)-3-cyclopentyl-7-(4-hydroxypiperidine-1-carbonyl)-3,3a,4,5-tetrahydro-2H-pyrazolo[3,4-f]quinolin-2-yl] benzonitrile
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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: 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 nameKBP-5074
    D.3.2Product code KBP-5074
    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 INNKBP-5074
    D.3.9.1CAS number 1359969-24-6
    D.3.9.2Current sponsor codeKBP-5074
    D.3.9.3Other descriptive name2-chloro-4-[(3S,3aR)-3-cyclopentyl-7-(4-hydroxypiperidine-1-carbonyl)-3,3a,4,5-tetrahydro-2H-pyrazolo[3,4-f]quinolin-2-yl] benzonitrile
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Moderate to Severe Chronic Kidney Disease and uncontrolled hypertension
    E.1.1.1Medical condition in easily understood language
    Chronic Kidney Disease and uncontrolled high blood pressure
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066860
    E.1.2Term Uncontrolled hypertension
    E.1.2System Organ Class 100000004866
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of KBP-5074 in patients with moderate-to-severe Chronic kidney disease (CKD) on uncontrolled hypertension (eg, Grade 1 to 2 systolic hypertension – ESC/ESH) as determined by change in trough cuff seated systolic blood pressure (SBP) from baseline to Day 84.
    E.2.2Secondary objectives of the trial
    To evaluate the change in trough cuff seated diastolic blood pressure from baseline to Day 84;
    To evaluate the change in 24-hour mean, daytime mean, nighttime mean, morning mean, last 6 hours of the dosing interval mean, SBP, DBP, mean arterial pressure and heart rate from baseline to Day 84 in a subset of patients as measured by 24-hour ambulatory blood pressure monitoring;
    To evaluate the change and percent change in urine albumin-to-creatinine ratio from baseline to Day 84 or microalbuminuria;
    To evaluate the change in serum aldosterone and plasma renin levels from baseline to Day 84;
    To evaluate the incidence of hyperkalemia, incidence of severe hyperkalemia and incidence of patients with serum potassium > 5.0 mmol/L;
    To evaluate the change in serum potassium levels from baseline to Day 84;
    To evaluate the changes in estimated glomerular filtration rate and creatinine levels > 30% throughout the study period;
    To evaluate population pharmacokinetics of KBP-5074.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, between 18 and 85 years of age, inclusive. The lower age limit may be higher if it is legally required in the participating country;
    2.Body mass index between 19 and 45 kg/m2, inclusive;
    3.Stage 3B/4 CKD (defined as eGFR ≥ 15 and ≤ 44 mL/min/1.73 m2, based on the isotope dilution mass spectrometry traceable MDRD equation version 4, according to central laboratory results at Screening;
    4. Uncontrolled hypertension (Grade 1 to 2 systolic hypertension – ESC/ESH), defined as:
    - Resting trough cuff seated SBP ≥ 140 and ≤ 179 mmHg based on the mean of at least 2 current consecutive clinic blood pressure readings at Screening and at the end of the placebo run-in period (Visit 3); AND
    - Currently on 2 or more antihypertensive medications, which have been titrated upward as tolerated to recommended hypertension target doses (such as diuretics [except for potassium-sparing diuretics], renin angiotensin system blockers, and/or calcium channel blockers. One of the antihypertensive medications must be high ceiling diuretic (loop or thiazide like), unless there is a documented intolerance or contraindication to diuretic therapy. The doses of the antihypertensive medications should be stable without any dose adjustment during the 30 days prior to randomization; OR
    - Patients with uncontrolled hypertension and moderate-to-severe CKD with documented history of intolerance to multiple antihypertensive medications on fewer than 2 antihypertensive medications;
    5. Serum potassium ≤ 4.8 mmol/L at both Screening and the end of the placebo run-in period. A single retest is allowed to exclude laboratory error or hemolyzed samples;
    6.Women of childbearing potential (WOCBP) must agree to use 2 medically accepted, effective methods of birth control during the study and for 90 days after the end of the study. Adequate methods of contraception are defined as those that result in a low failure rate (< 1% per year) when used consistently and correctly.
    - WOCBP are defined as women who are not surgically or chemically sterilized, including hysterectomy or bilateral oophorectomy (tubal ligation is not acceptable), and who are between menarche and 1-year post-menopause; and
    - Post-menopausal is defined as amenorrheic for at least 1 year, AND if aged under 60 years, have a serum follicle-stimulating hormone (FSH) level > 20 mIU/L. Women who are taking hormone replacement therapy (HRT) do not have to have FSH assessments, but the amenorrhea (before starting HRT) must have been naturally (spontaneously) occurring and have been accompanied by an appropriate clinical profile (eg, age appropriate and history of vasomotor symptoms);
    7.Males with partners who are WOCBP must agree to use condoms plus spermicide and their female partner must also be using contraception (eg, hormonal or intra-uterine device). This double contraception must be used from the first dose of study drug until at least 90 days after the last dose of study drug;
    8. Males must also refrain from donating sperm during the study and for 90 days after the last dose;
    9.Capable of understanding the written informed consent, provide signed and witnessed written informed consent before any study-specific procedure, and agree to comply with protocol requirements.
    E.4Principal exclusion criteria
    1. Resting trough cuff seated SBP ≥ 180 or < 140 mmHg, based on the mean of at least 2 current consecutive clinic blood pressure readings at Screening and the end of the placebo run-in period;
    2. Serum potassium > 4.8 mmol/L;
    3. Compliance with medications < 80% or > 120% during the run-in period;
    4. Currently on an MRA other than KBP-5074 or received any MRAs during the last 3 months prior to Screening or currently on any potassium supplements;
    5. Chronic or intermittent use of a potassium binder for the treatment of hyperkalemia from 3 months prior to Screening until the end of study assessments;
    6. Have routinely or chronically used or required potassium-sparing diuretics within 3 months prior to Screening until the end of study assessments;
    7. History of known/suspected contraindications, allergy, or intolerance to MRAs or has a known hypersensitivity to KBP-5074, other MRAs or related compounds;
    8. Clinically significant hyperkalemia while on an angiotensin converting enzyme inhibitor, angiotensin receptor blocker, direct renin inhibitor and/or MRA, requiring down titration or discontinuation of above medication, or hospitalization for hyperkalemia within 3 months prior to Screening, or hyperkalemia > 5.6 mmol/L during the 2 weeks prior to Screening;
    9. History/diagnosis of renal artery stenosis or history/diagnosis of renovascular hypertension;
    10. Currently receiving HD, or peritoneal dialysis within 3 months prior to Screening, and those patients with an episode of acute kidney injury within 3 months of Screening;
    11. History of a renal transplant, or impending renal transplant;
    12. Acute decompensated heart failure including exacerbation of chronic heart failure manifested by signs and symptoms that may require hospitalization and/or intravenous diuretic therapy within 3 months prior to Screening, or presence of hemodynamically significant valve diseases and/or other hemodynamically significant obstructive lesions of left ventricular outflow tract;
    13. Major cardiac, cerebral, and/or carotid artery diseases within 6 months prior to Screening; OR Cardiovascular conditions likely to require surgical or percutaneous intervention within 6 months from Screening;
    14. History of clinically significant arrhythmia, including but not limited to any of the following:
    -Symptomatic bradycardia and/or symptomatic ventricular arrhythmia within 3 months prior to Screening
    - Second- or third-degree heart block or New onset or untreated atrial fibrillation
    15. QT interval corrected using Fridericia’s formula (QTcF) > 450 ms for males or > 470 ms for females at Screening or Day 1; QTcF should be the average of the required triplicate set of ECGs at each timepoint
    16. History of prolonged QT interval;
    17. History or family history of sudden cardiac death or long QT syndrome;
    18. History of cardiac transplant, on a heart transplant list, or has a left ventricular assistance device;
    19. History of clinically significant acute or chronic hepatitis, hepatocirrhosis, or hepatic tumors;
    20. History of gastrointestinal surgery that might affect absorption/oral bioavailability of oral antihypertensive therapies including KBP-5074;
    21. Clinically significant abnormal liver function test at Screening or the end of the run-in period;
    22. Positive blood screen for HIV, hepatitis B surface antigen, or hepatitis C virus antibody;
    23. History of malignancy in the past 5 years, with the exception of basal or resected cutaneous squamous cell carcinoma of the skin or carcinoma in situ, prostate cancer in situ with a normal prostate-specific antigen post treatment, cervical carcinoma in situ, gastric cancer in situ, colon cancer in situ adequately treated with no progression over the past 2 years;
    24. History of prescription drug abuse, illicit drug use, or alcohol abuse according to medical history within 6 months prior to Screening;
    25. A positive drug screen test at Screening or the end of the run-in period;
    26. Female patients who are known to be pregnant or breastfeeding;
    27. Previously enrolled in any KBP-5074 study;
    28. Receipt of any other investigational product within 30 days or 5 half-lives prior to Screening;
    29. Use of any nutrients known to modulate cytochrome P450 (CYP)3A activity or any strong or moderate inhibitors or inducers of CYP3A4, starting from 14 days prior to the first dose of study drug at Day 1 until the end of study assessments;
    30. Has donated or lost a significant volume (> 500 mL) of blood or plasma within 30 days prior to Screening
    31. An employee or family member of the Investigator or study site personnel;
    32. Unlikely to comply with the protocol requirements, instructions, and/or study-related restrictions ;
    33. History of any other prior or concomitant clinical condition or acute and/or unstable systemic disease not listed above that, in the opinion of the Investigator, compromises patient inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the change in trough-cuff resting seated SBP from baseline to Day 84.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    E.5.2Secondary end point(s)
    The key secondary efficacy variables include the following:
    • Change in trough-cuff seated DBP from baseline to Day 84;
    • Change in 24-hour mean, daytime mean, nighttime mean, morning mean, last 6 hours of the dosing interval mean, SBP, DBP, MAP, and HR from baseline to Day 84 as measured by 24-hour ABPM in a subset of up to 40 patients per treatment group; and
    • Change and percent change in UACR from baseline to Day 84 (for patients with albuminuria [defined as UACR > 300 mg/g] or microalbuminuria [defined as UACR in the range of 30 mg/g to 300 mg/g]).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 84
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Bulgaria
    Chile
    Georgia
    Hungary
    Israel
    Ukraine
    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
    LVLS
    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 months
    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 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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 80
    F.4.2.2In the whole clinical trial 240
    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)
    Subsequent treatments of the study subject will be at the discretion of the investigator in accordance to standard care.
    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 Decision2019-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-05
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA