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    Summary
    EudraCT Number:2020-005559-19
    Sponsor's Protocol Code Number:FUR-03-17
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-04
    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 number2020-005559-19
    A.3Full title of the trial
    FRUTI - a phase III, randomized, multicenter, double-blind, active control study to evaluate the efficacy and safety of Furazidin prolonged-release tablets, 200 mg compared with Nitrofurantoin prolonged-release capsules, 100 mg, in the treatment of patients with uncomplicated lower urinary tract infections (acute or recurrent)
    FRUTI - randomizowane, wieloośrodkowe, podwójnie zaślepione, badanie III fazy z aktywną grupą kontrolną, oceniające skuteczność i bezpieczeństwo Furazydyny w tabletkach 200 mg o przedłużonym uwalnianiu, w porównaniu z Nitrofurantoiną w kapsułkach 100 mg o przedłużonym uwalnianiu, w leczeniu pacjentów z niepowikłanymi infekcjami dolnych dróg moczowych (ostrymi lub nawracającymi)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Furazidin for resolution or improvement of all clinical symptoms of Urinary Tract Infections
    Furazydyna dla ustąpienia lub poprawy wszystkich objawów klinicznych zakażeń dróg moczowych
    A.3.2Name or abbreviated title of the trial where available
    FRUTI
    FRUTI
    A.4.1Sponsor's protocol code numberFUR-03-17
    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 SponsorADAMED Pharma S.A.
    B.1.3.4CountryPoland
    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 supportADAMED Pharma S.A.
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationADAMED Pharma S.A.
    B.5.2Functional name of contact pointPiotr Witkowski
    B.5.3 Address:
    B.5.3.1Street AddressMariana Adamkiewicza 6A, Pieńków
    B.5.3.2Town/ cityCzosnów
    B.5.3.3Post code05-152
    B.5.3.4CountryPoland
    B.5.4Telephone number+48539 525 490
    B.5.5Fax number+4822716 55 33
    B.5.6E-mailPiotr.Witkowski@adamed.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 nameFurazidin prolonged-release tablets, 200 mg
    D.3.2Product code Furazidin PR
    D.3.4Pharmaceutical form Prolonged-release 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 INNFurazidine
    D.3.9.1CAS number 1672-88-4
    D.3.9.2Current sponsor codeFurazidin PR
    D.3.9.3Other descriptive nameFuragina, Furaginum, Furagin
    D.3.9.4EV Substance CodeSUB16433MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 RoleComparator
    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 Uvamin Retard, 100 mg capsules
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA B.V., the Netherlands
    D.2.1.2Country which granted the Marketing AuthorisationLithuania
    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.3.4Pharmaceutical form Prolonged-release capsule, hard
    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 INNNitrofurantoin
    D.3.9.1CAS number 67-20-9
    D.3.9.2Current sponsor codeNitrofurantoin PR
    D.3.9.4EV Substance CodeSUB09326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    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 placeboProlonged-release capsule, 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
    uncomplicated lower urinary tract infections (acute or recurrent)
    niepowikłane infekcje dolnych dróg moczowych (ostre lub nawracające)
    E.1.1.1Medical condition in easily understood language
    urinary tract infections
    infekcje dróg moczowych
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10046571
    E.1.2Term Urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10024981
    E.1.2Term Lower urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038140
    E.1.2Term Recurrent urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate at least the same efficacy (a non-inferiority
    design) of Furazidin PR versus Nitrofurantoin PR in the treatment of the uncomplicated lower
    urinary tract infections (cystitis) in women (acute or recurrent).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • assessment of microbial response;
    • assessment of clinical response;
    • patient assessment of efficacy and quality of life;
    • evaluation of patient compliance with dosing regimen;
    • evaluation of safety profile;
    • observation of the treatment efficacy during Visit 2 at Day 5 (First Resolution) to find out
    whether the study results will be supportive enough to make the treatment posology
    shorter);
    • evaluation of patient compliance with dosing recommendation in respect to the meals.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria
    The patients meeting the below mentioned criteria will be included into the study:
    1. Informed Consent: Willingness to comply with all the study activities and procedures and
    provision of signed and dated, written informed consent form prior to any mandatory study
    specific procedures, sampling, and analyses. For pediatric population, parents’ or legal
    guardian’s informed consent will be required.
    2. Age: Subject must be ≥ 12 years of age at the time of signing the informed consent form.Germany only: Subject must be ≥ 18 years of age at the time of signing the informed consent
    form.
    3. Sex: female.
    4. Patients with diagnosis of the acute or recurrent uncomplicated lower urinary tract infection
    (cystitis). For the purposes of this study, urinary tract infection (cystitis) is defined by:
    a) presence of at least two of the following clinical symptoms: dysuria, urinary
    frequency, urinary urgency, suprapubic pain,
    and
    b) at least a score of 6 of typical symptoms obtained by the Acute Cystitis Symptom
    Score (ACSS) questionnaire applied as additional tool for the clinical inclusion criteria
    defined by the draft guideline on the evaluation of medicinal products indicated for
    treatment of bacterial infections (EMA/844951/2018 Rev. 3)
    and
    c) presence of pyuria, as determined by a dipstick test positive for leukocyte esterase or at
    least 10 leukocytes per cubic millimeter [1 μl] (WBC ≥ 10/mm3) as required by the draft
    EMA Guideline (EMA/844951/2018 Rev. 3).
    5. Onset of symptoms of urinary tract infection at least 12 hours but not more than 72h prior to
    Visit 1 (Screening).
    6. No prior treatment with systemic antibiotics and/or chemotherapeutic agents for any reason
    within 7 days prior to Visit 1.
    7. Negative urine pregnancy test for female subjects of childbearing potential.
    8. Female patients must be post-menopausal (i.e.: no menstrual bleeding for at least 12
    consecutive months), surgically sterile (i.e. after surgery as bilateral tubal ligation, bilateral
    ovarectomy or hysterectomy), or using an highly-effective method of contraception (defined
    as: combined oral, transdermal or intravaginal (estrogen and progestogen containing)
    hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal
    contraception associated with inhibition of ovulation (oral, injectable or implantable),
    intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal
    occlusion, vasectomised partner, sexual abstinence). Additional barrier methods in
    conjunction with spermicide are recommended to be used.
    E.4Principal exclusion criteria
    Patients must not meet any of the following exclusion criteria:
    1. Symptoms suggesting probability of SARS-CoV-2 infection or known positive COVID-19 rapid antigen test within last 7 days.
    2. Direct contact with a person suffering from COVID-19 within 14 days before Visit 1.
    3. Traveled and stayed more than 48 hours in the country affected with SARS-CoV-2 transmition within 14 days before Visit 1, with an exemption of fully anti-COVID-19 vaccinated patients.
    4. Any symptoms of complicated urinary tract infections (cUTI), pyelonephritis (i.e., fever T
    ≥ 38.0˚C, flank pain (costovertebral angle pain), chills and/or inflammation of the vulva and vagina and/or abnormal discharge from the vagina or urethra) at Visit 1.
    5. Known clinically significant anatomic and functional disorders of the urinary tracts (including, but not limited to congenital malformations, conditions after surgery within the urogenital tracts during the last 30 days, clinically significant residual urine (more than 100
    ml of urine being retained in urinary bladder based on PVR USG examination*), neurogenic bladder, urolithiasis, urogenital system malignancies) allowing to recognize complicated urinary tract infection.
    6. Previous UTI episode treated (resolved or unresolved) within 4 weeks before Visit 1.
    7. As judged by the investigator, any evidence of disease/condition which in the investigator’s opinion makes it undesirable for the subject to participate in the trial.
    8. Any intake of systemic bacteriostatic agents and/or antibiotics within 7 days prior to Visit 1 and OTC drugs, including ibuprofen and other NSAIDs, and/or dietary supplements, food preparations used in the urinary tract infections, within 7 days prior to Visit 1, with an exemption for acetylosalicylic acid at a stable dose of 75 mg or 150 mg per day, taken over
    30 days before Visit 1 to reduce blood clotting.
    9. Hypersensitivity to furazidin, nitrofurantoin, nitrofuran derivatives or other drug components.
    10. Other acute infections (except for acute UTI) requiring antibiotic treatment at Visit 1.
    11. Catheter in the bladder or any other foreign body in the urinary tracts.
    12. Overactive bladder.
    13. Menstrual bleeding at the day of visit.
    14. Immunomodulatory prophylaxis due to urinary tract infection within 6 months prior to Visit 1.
    15. Treatment with vitamin K antagonists (Warfarin, Acenocumarol) as long the INR test is out of the normal values resulting in significant haematuria (decision about randomization to be made based on the last INR result), probenecid, sulfinpirazon, alkalising drugs containing magnesium trisilicate, ristomycin, metoclopramide, nalidixic acid, atropine, levomicetin, sulphanilamide within 7 days before Visit 1.
    16. The presence of known severe renal impairment.
    17. The known presence of:
    a. severe abdominal pain with special attention to pancreatitis (strong abdominal pain in the area of epi- or mesogastrium, girdle or radiating to back area, nausea and vomiting, diarrhorea)
    b. electrolytes disturbancies (based on symptoms assessment: irregular heartbeat, tachycardia, fatigue, lethargy, convulsions or seizures, nausea, vomiting, diarrhea or constipation, abdominal cramping, muscle cramping, muscle weakness, irritability, confusion, headaches, numbness and tingling)
    c. polycystic kidney disease, severe pulmonary disease, diagnosed polyneuropathy, e.g. diabetic polyneuropathy, known glucose-6-phosphate dehydrogenase deficiency, anemia, known deficiency of vitamins B and folic acid, neutropenia, severe thrombocytopenia, liver
    failure, porphyria, immunosuppressive or immunomodulatory treatment, HIV/AIDS infection, chemotherapy, steroid therapy, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency – data obtained on the basis of patient
    medical history.
    18. The known history of cancer disease, that is not cured nor stable within 12 months prior to Visit 1.
    19. Active peptic ulcers.
    20. Current or previous history of addiction to alcohol and/or drugs.
    21. Investigator’s opinion that the patient should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.
    22. The legal inability and/or other circumstances that prevent the patient's understanding of the extent and possible influence of the study.
    23. Sound suspicion that the patient fails to comply with the study protocol directives.
    24. Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial
    involving an investigational drug, including nitrofurantoin and furazidin in any dosage
    forms, or device or off-label use of a drug or device other than the study drug/device used
    in this study, or concurrently enrolled in any other type of medical research judged not to
    be scientifically or medically compatible with this study.
    25. Pregnancy or breastfeeding.
    26. Are investigator site personnel directly affiliated with this study and/or their immediate
    families. Immediate family is defined as a spouse, parent, child, or sibling, whether
    biological or legally adopted.
    27. Are Sponsor’s /CRO’s employees/relatives.
    28. Any conflict of interest or condition that might affect the objective assessments and
    measurements.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy criteria is defined as a composite endpoint consisting of the resolution or
    improvement of all clinical symptoms of urinary tract infection without need of additional
    antibacterial therapy and the efficacy measure according to the ACSS self-assessment scale (a
    score of typical symptoms of the ACSS ≤ 5 but no item > 1 (mild) and no visible blood in urine)
    and the demonstration that the bacterial pathogen found at trial entry in CFU > 10^5 / mL is reduced to fewer than
    103 CFU/mL on urine culture during Visit 4 (Test of Cure Visit, Day 14 (+/- 2)).
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 days (+/- 2 days)
    E.5.2Secondary end point(s)
    Secondary efficacy parameters include the following:
    • Number of patients that achieved resolution or improvement of all clinical symptoms of UTI according to the ACSS self-assessment scale (a score of typical symptoms of ACSS ≤ 5 but no item > 1 (mild)) and no visible blood in urine at Visit 2 (First Resolution), Visit 3 (End of Treatment), Visit (Test of Cure), and Visit 5 (Follow up) in Furazidin PR arm in relation to Nitrofurantoin PR arm; [Time Frame: Day 5, Day 7, Day 14, Day 28];
    • Number of patients that achieved reduction of pathogens count, present at the study entry (at Visit 1), to a level <10^3 CFU/ml in urine culture at Visit 4 (Test of Cure), in Furazidin PR arm in relation to Nitrofurantoin PR arm; [Time Frame: Day 14];
    NOTE: All patients meeting study entry criteria with positive bacteriuria (CFU > 10^3/ ml), regardless the baseline bacteriuria CFU > or ≤ 10^5/ml and nitrofurantoine susceptibility will be assessed for microbiological secondary endpoint.
    • Number of patients with new infections at Visit 4 [Time Frame: Day 14].
    • Number of patients with a need of any other antimicrobial medication intake for UTI between Visit 1 and Visit 4 and between Visit 1 and Visit 5 in Furazidin PR arm in relation to Nitrofurantoin PR arm; [Time Frame: Day 5, Day 7, Day 14, Day 28];
    • Maintenance of clinical response until Day 28 (Visit 5 - Follow up) in Furazidin PR arm in relation to Nitrofurantoin PR arm, based on the ACSS self-assessment scale (a score of typical symptoms of ACSS ≤ 5 but no item > 1 (mild)) and no visible blood in urine); [Time Frame: Day 28];
    • Change in the patient self-reporting quality of life using the ACSS questionnaire at Visit 1, Visit 2 (First Resolution), Visit 3 (End of treatment), Visit 4 (Test of Cure), Visit 5 ( Follow-up); in Furazidin PR arm in relation to Nitrofurantoin PR arm; [Time Frame: Day 1, Day 5, Day 7, Day 14, Day 28];
    • Number of Treatment-Emergent AEs/ SAEs collected during the course of the study since Visit 1 until Visit 5 in Furazidin PR arm in relation to Nitrofurantoin PR; [Time Frame: Day 1 to Day 28];
    • The susceptibility of infecting strains to Furazidin PR and Nitrofurantoin PR; [Time Frame: Day 1, Day 14];
    • Patient compliance with study treatment dosing regimen, defined as the range of 71- 129% of total dose of study treatment that should be taken during the course of the study; [Time Frame: Day 14];
    • Patient compliance of study treatment administration in respect to meals; compliance defined as at least 71% doses administrated as per recommendations; [Time Frame: Day 14];
    • Clinical response to study treatment in relation to patient compliance with study treatment administration in respect to meals; [Time Frame: Day 14].
    NOTE: Patients who entered the study and received study medication but failed to fulfill study microbiological inclusion criteria will be evaluated in the same manner as above.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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 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 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned32
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Germany
    Hungary
    Poland
    Russian Federation
    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 years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 612
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state447
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 636
    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)
    Patients will be treated with the prevailing standard of medical 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 Decision2021-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-09
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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