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    Summary
    EudraCT Number:2016-002781-31
    Sponsor's Protocol Code Number:PQBirch301
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-002781-31
    A.3Full title of the trial
    A multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Birch Modified Allergen Tyrosine adsorbed + MPL in the prevention of seasonal symptoms in subjects with allergic rhinoconjunctivitis due to birch pollen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this phase III placebo-controlled study is to evaluate the efficacy and safety of a cumulative dose of PQ Birch 27300 standardised units (SU) in the treatment of patients suffering fromallergic rhinoconjunctivitis due to birch pollen.
    A.3.2Name or abbreviated title of the trial where available
    A multi-centre study of the efficacy and safety of PQBirch [PQBirch301]
    A.4.1Sponsor's protocol code numberPQBirch301
    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 SponsorAllergy Therapeutics (UK) 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 supportAllergy Therapeutics (UK) Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBencard Allergie GmbH
    B.5.2Functional name of contact pointClinical Research Management
    B.5.3 Address:
    B.5.3.1Street AddressLeopoldstr. 175
    B.5.3.2Town/ cityMünchen
    B.5.3.3Post code80804
    B.5.3.4CountryGermany
    B.5.4Telephone number+4908936811436
    B.5.5Fax number+490893681122420
    B.5.6E-mailpqbirch301@allergytherapeutics.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 namePollinex Quattro Birch (900SU/ml)
    D.3.2Product code V01A A05
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 namePollinex Quattro Birch (2400 SU/ml)
    D.3.2Product code V01A A05
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 namePollinex Quattro Birch (6000 SU/ml)
    D.3.2Product code V01A A05
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameBIRCH POLLEN MODIFIED ALLERGEN TYROSINE-ADSORBED
    D.3.9.4EV Substance CodeSUB122723
    D.3.10 Strength
    D.3.10.1Concentration unit SU/ml Standardised Unit(s)/millilitre (Deprecated)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Seasonal allergic rhinoconjunctivitis due to birch pollen
    E.1.1.1Medical condition in easily understood language
    Hay Fever due to birch pollen
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001728
    E.1.2Term Allergic rhinoconjunctivitis
    E.1.2System Organ Class 100000014962
    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 evaluate the efficacy of PQ Birch
    in birch pollen-induced rhinoconjunctivitis.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the safety and
    tolerability of PQ Birch in birch pollen-induced rhinoconjunctivitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent available.
    2. Male or female aged 18 to 60 years inclusive at the time of signing the consent form.
    3. Female patients are allowed to participate in the study if they are:
    i. Not of childbearing potential, defined as: post-menopausal (defined as natural spontaneous amenorrhea for at least 12 months, or at least 6 weeks following surgical menopause), or
    ii. Naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study screening).
    iii. Non-pregnant, non-lactating with negative urinary pregnancy test at all visits leading up to randomisation and using at least one of the following contraceptive methods:
    a) Stable hormonal contraceptive for ≥ 90 days prior to the study and for at least 7 days after the final injection. If < 90 days prior to the study, additional use of a double barrier method until 90 days are reached is required or,
    b) Placement of an intrauterine device (IUD) or intrauterine hormone-releasing system or,
    c) Successful male sterilisation of the sole partner (patient must verbally confirm that appropriate post-vasectomy documentation of the absence of sperm in the ejaculate was provided after the procedure) or,
    d) True abstinence when in line with the preferred and usual lifestyle of the patient.
    Periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception.
    4. Good general health, as determined by the investigator based on a medical evaluation including medical history, physical examination and laboratory tests. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
    5. Positive history of moderate to severe seasonal allergic rhinoconjunctivitis ascribed to birch pollen exposure which required anti-allergic treatment for symptom control for at least two consecutive seasons prior to the study.
    6. A positive skin prick test (SPT) for birch pollen (wheals [longest diameter] ≥ 3 mm and histamine ≥ 3 mm) and a negative SPT to the negative control (wheal diameter=0) at screening.
    7. Birch-specific IgE class ≥ 2 as documented by an immunoCAP test at screening.
    8. Forced expiratory volume (FEV) in 1 second (FEV1) ≥ 80 % of predicted, with an FEV1/Forced Vital Capacity (FVC) ratio ≥ 70 %.
    9. The drug washout times listed in the table “Prohibited Medications/Therapies” (see Exclusion Criterion 16 and section 5.10.2 Prohibited Medications) prior to Visit 1 and Visit 2 are observed. The use of other medications will be permitted if they are not expected to interfere with the ability of the patient to participate in the study and provided they have been on a stable regimen (i.e., the same dosage and administration form) for 30 days prior to screening.
    10. The patient understands the implications of trial participation, provided in local language in the written informed consent form, and demonstrates willingness to comply with instructions and to attend the required study visits.
    E.4Principal exclusion criteria
    1. Pregnant or lactating.
    2. Positive SPT (wheal [longest diameter] ≥ 3 mm) at V1 to:
    a) Ash (Fraxinus excelsior).
    b) Gras Pollen Mix. Exception: Patients with no positive case history of moderate to severe symptoms at any time during the 3 years prior to visit 1* may be enrolled.
    c) House dust mites (Dermatophagoides pteronyssinus or Dermatophagoides farinae) or moulds (Alternaria alternata). Exception: Patients with no positive case history of moderate to severe symptoms at any time during the 3 years prior to V1 may be enrolled.
    d) Epithelia (cat fur and dog hair). Exception: Patients with no positive case history of moderate to severe symptoms at any time during the 3 years prior to Visit1 or patients who can avoid the allergen of concern for the duration of the trial may be enrolled.
    e) Mugwort (Artemisia vulgaris), English plantain (Plantago lanceolata) or Ragweed (Ambrosia elatior) with a positive case history of moderate to severe symptoms during the 3 years prior to Visit 1. Exc.: The patient can return for the treatment period after end of the relevant pollen season. Testing not required if the allergen is uncommon to the region or the allergy season is over at the time of screening or treatment.
    3. Moderate to severe symptoms to another seasonal or perennial allergen not listed in exclusion criterion 2 that cannot be avoided and the symptoms of which may interfere with administration of treatment and/or impact the data collected during the BPS.
    4. History of immunological disorders or other diseases that may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
    5. Presence of moderate to severe asthma, characterised by the requirement to use of inhaled steroids at a daily dose budesonide >400 µg or equivalent.
    6. Emergency room visit or hospitalisation for asthma in the 12 months prior to Visit 1 or any history of a life-threatening asthma attack.
    7. Presence of non-atopic rhinitis and/or rhino-sinusitis (with or without polyps).
    8. Presence of any skin conditions which might interfere with the interpretation of the SPT results.
    9. Current diagnosis of type I diabetes. Patients with type II diabetes will only be allowed to participate at the discretion of the investigator.
    10. History of allergen-specific immunotherapy (SIT). Exc.: The SIT occurred > 5 years prior to Visit 1, at least one full annual course of SIT was completed, and a successful effect on symptom control was observed for at least 1 pollen season after treatment.
    11. Treatment with a preparation containing MPL® within 6 months prior to Visit 1 and , with the exception of the study drug, until after completion of Visit 10/10a.
    12. Any acute infection (including upper respiratory tract infections) within 14 days of Visit 2.
    13. Clinical history of severe or life-threatening anaphylactic reactions to foods, insect venom, drugs, idiopathic anaphylaxis or physical exercise.
    14. Clinical history of any allergy, hypersensitivity to or intolerance of the excipients of the study medication.
    15. Tyrosine metabolism disorders, especially tyrosinaemia and alkaptonuria.
    16. Inability to adhere to washout periods listed in table Prohib. Medications/Therapies with respect to V1 and V2 and to refrain from using the medications indicated from V2 until after completion of V10/10a except of relief medications.
    17. Inability to receive epinephrine therapy.
    18. Beta blocker medication, including eye drops, for any indication.
    19. Monoamine oxidase inhibitor medication, tricyclic antidepressants, ACE inhibitors.
    20. Anti-IgE therapy (e.g. Xolair), any previous or current therapy.
    21. All vaccinations (incl. influenza) administered 7 days or less prior to randomization or any planned vaccinations up to 1 week following the last administration of study drug. Emergency vaccinations (e.g.tetanus due to injury) can be administered at any time.
    22. Current or past therapy (within previous 5 years) with immunosuppressant drugs or immunomodulatory biologics.
    23. Clinical history of drug or alcohol abuse which would, , interfere with the patient’s ability to participate in the study.
    24. Participation in a clinical research trial with any investigational medicinal product within 4 weeks of V1 or concomitantly with this study.
    25. Unwilling or unable to comply with the procedures described in this protocol.
    26. Personal, financial or other dependent relationship (e.g. employee or immediate relative) with the study site, sponsor, sponsor’s representative, or any other individual who has access to the clinical study protocol.
    27. Judicial or governmental detention, detainment or imprisonment in a public institution.
    28. Prolonged periods of absence from home during the BPS (e.g. business or private travel) of greater than 3 consecutive days in one week (Monday to Sunday) or a total of 7 days during BPS.
    29. Change of residence between geographical regions since last birch pollen season.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the total combined symptom medication score
    (CSMS) of the rhinoconjunctivitis daily symptom score (dSS) and
    rhinoconjunctivitis daily medication score (dMS), averaged over the peak
    birch pollen season (BPS).
    E.5.2Secondary end point(s)
    Efficacy:

    1. The average rhinoconjunctivitis CSMS over the entire BPS
    2. The average rhinoconjunctivitis daily symptoms scores (dSS) and dMS separately averaged over the peak and entire BPS
    3. The average rhinoconjunctivitis CSMS during the BPS based on the peak placebo-score period (26)
    4. The probability of well days and severe days during the peak and entire BPS
    5. The change in immunological responses (total IgE, specific IgE, IgG and IgG4, specific IgE/total IgE ratio) between screening and Visit 10/10a
    6. The change in quality of life as assessed by the RQLQ(s) over the entire BPS

    Safety/Tolerability:

    1. Frequency, severity and relationship of AEs
    2. Frequency and intensity of ARCs (defined by the maximum intensity of all injection site (local) and systemic AEs experienced by a patient within a 24-hour period after any injection)
    3. Frequency of premature discontinuation from treatment or study due to AEs
    4. Changes in clinical laboratory values (chemistry, haematology, urinalysis) between screening and Visit 10/10a
    5. Changes in vital sign parameters at all visits during the treatment period between pre-injection and post-injection
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 562
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 562
    F.4.2.2In the whole clinical trial 562
    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)
    Continuous medical care and follow-up after completion or termination of the study or after early study termination lies within the responsibility of the investigator and will be done according to state of the art.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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