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    Summary
    EudraCT Number:2018-003202-82
    Sponsor's Protocol Code Number:MK7655A-016
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003202-82
    A.3Full title of the trial
    Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects with Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMI/REL (MK-7655A) vs. PIP/TAZ for Treatment of Subjects with HABP/VABP
    A.3.2Name or abbreviated title of the trial where available
    IMI/REL (MK-7655A) vs. PIP/TAZ for Treatment of Subjects with HABP/VABP
    A.4.1Sponsor's protocol code numberMK7655A-016
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03583333
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointCarisa De Anda
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey,
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 858-352-2639
    B.5.6E-mailcarsisa.de.anda@merck.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 nameimipenem/cilastatin/relebactam (IMI/REL)
    D.3.2Product code MK-7655A
    D.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRELEBACTAM
    D.3.9.2Current sponsor codeMK-7655
    D.3.9.4EV Substance CodeSUB184909
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCILASTATIN
    D.3.9.1CAS number 82009-34-5
    D.3.9.4EV Substance CodeSUB06264MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIPENEM
    D.3.9.1CAS number 64221-86-9
    D.3.9.4EV Substance CodeSUB08151MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Piperacillin/Tazobactam 4 /0.5 g
    D.2.1.1.2Name of the Marketing Authorisation holderAccord Healthcare S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPIPERACILLIN
    D.3.9.3Other descriptive namePIPERACILLIN
    D.3.9.4EV Substance CodeSUB09867MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAZOBACTAM
    D.3.9.3Other descriptive nameTAZOBACTAM
    D.3.9.4EV Substance CodeSUB10849MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Hospital-Acquired Bacterial Pneumonia / Ventilator-Associated Bacterial Pneumonia
    E.1.1.1Medical condition in easily understood language
    Hospital acquired bacterial pneumonia/ ventilator associated bacterial pneumonia
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10004051
    E.1.2Term Bacterial pneumonia, unspecified
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the incidence rate of all-cause mortality through Day 28 post-randomization associated with treatment with IMI/REL compared to treatment with PIP/TAZ in the modified intention-to-treat (MITT) population.
    E.2.2Secondary objectives of the trial
    1. To evaluate favorable clinical response (CR) rate associated with treatment with IMI/REL compared to treatment with PIP/TAZ in the following visits and analysis populations:
    - At the early follow-up (EFU) visit in the MITT population
    - At the EFU visit in the clinically evaluable (CE) population
    - At the end of treatment (EOT) visit in the MITT population
    - At the EOT visit in the CE population
    2. To evaluate favorable microbiological response (MR) rate associated with treatment with IMI/REL compared to treatment with PIP/TAZ in the following visits and analysis populations:
    - At the EFU visit in the microbiologically evaluable (ME) population
    - At the EOT visit in the microbiologically modified intention-to-treat (mMITT) population
    - At the EOT visit in the ME population
    3. Objective: To evaluate the safety and tolerability profile of IMI/REL compared with PIP/TAZ.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (Blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1. Require treatment with IV antibiotic therapy for HABP or VABP.
    2. Fulfill the clinical and radiographic criteria described below, with onset of criteria occurring after more than 2 days (48 hours) of hospitalization or within 7 days after discharge from a hospital (for HABP) or at least 2 days (48 hours) after mechanical ventilation (for VABP):
    (a) Participant has at least one of the following clinical features:
    - New onset or worsening pulmonary symptoms or signs, such as cough, dyspnea, tachypnea (eg, respiratory rate greater than 25 breaths per minute), expectorated sputum production, or requirement for mechanical ventilation
    - Hypoxemia (eg, a partial pressure of oxygen less than 60 millimeters of mercury while the participant is breathing room air at standard atmosphere pressure, as determined by arterial blood gas [ABG] or worsening of the ratio of the partial pressure of oxygen to the fraction of inspired oxygen [PaO2/FiO2])
    - Need for acute changes in the ventilator support system to enhance oxygenation, as determined by worsening oxygenation (ABG or PaO2/FiO2) or needed changes in the amount of positive end-expiratory pressure
    - New onset of suctioned respiratory secretions
    AND
    (b) Participant has at least one of the following signs:
    - Documented fever (body temperature ≥38 degrees Celsius)
    - Hypothermia (body temperature ≤35 degrees Celsius)
    - Total peripheral white blood cell (WBC) count ≥10,000 cells/cubic millimeter (mm3)
    - Leukopenia with total WBC ≤4,000 cells/mm3
    - Greater than 15 percent immature neutrophils (bands) noted on peripheral blood smear
    AND
    (c) Participant has a chest radiograph showing the presence of a new or progressive infiltrate(s) suggestive of pneumonia.
    3. Have an adequate baseline (at or within 2 days [48 hours] of screening) lower respiratory tract specimen obtained for Gram stain and culture.
    4. Have an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy.
    5. Agree to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing and long-term storage.
    6. Be between 18 to 75 (inclusive) years of age on the day of signing informed consent.
    7. A male participant must agree to use contraception as detailed in the protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period.
    8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    a.) Not a woman of childbearing potential (WOCBP)
    OR
    b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study.
    9. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However the participant may participate in the main study without participating in future biomedical research.
    10. If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin before receipt of first dose of IV study therapy.
    E.4Principal exclusion criteria
    1. Has a baseline lower respiratory tract specimen Gram stain that shows the presence of gram-positive cocci only.
    2. Has confirmed or suspected community-acquired bacterial pneumonia (CABP).
    3. Has confirmed or suspected pneumonia caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology.
    4. Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction.
    5. Has a carcinoid tumor or carcinoid syndrome.
    6. Has active immunosuppression, defined as either receiving immunosuppressive medications or having a medical condition associated with immunodeficiency. Including but not limited to:
    (1) HIV (AIDS or CD4 <200 cell/mm³),
    (2) Chemotherapy was performed within 6 weeks before randomization,
    (3) Immunosuppressive therapy, including maintenance glucocorticoid therapy (>40mg/d prednisolone equivalent dose), (4) Neutrophilic granulocyte absolute count<500/mm³.
    7. The participant is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy.
    8. Has a concurrent condition or infection that, in the investigator’s judgment, would preclude evaluation of therapeutic response (eg, active tuberculosis, cystic fibrosis, granulomatous disease, a disseminated fungal infection, invasive fungal pulmonary infection or endocarditis).
    9. Has a history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to any of the following:
    - any β-lactams (including PIP/TAZ, carbapenems, cephalosporins, or other β-lactam agents)
    - β-lactamase inhibitors (eg, tazobactam, sulbactam, clavulanic acid, avibactam)
    10. Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years.
    11. Is currently undergoing hemodialysis or peritoneal dialysis.
    12. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or pose additional risk in administering the study drugs to the participant.
    13. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; a WOCBP who has a positive serum pregnancy test will be excluded.
    14. Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours.
    15. Is anticipated to be treated with any of the following medications during the course of study therapy:
    - valproic acid or divalproex sodium (or has used valproic acid or divalproex sodium in the 2 weeks prior to screening)
    - serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), or monoamine oxidase inhibitors
    - monoamine oxidase inhibitors (MAOIs) (or has used MAOIs during the 2 weeks prior to screening)
    - meperidine
    - buspirone
    - concomitant systemic (IV or oral) antibacterial agents in addition to those designated in the study treatment groups
    - concomitant systemic (IV or oral) antifungal or antiviral therapy for the index infection of HABP/VABP
    - traditional Chinese medicine or herbal medicine
    16. Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial.
    17. Has previously participated in this study at any time.
    18. Has an estimated or actual creatinine clearance of <15 mL/min at screening, based on the findings of local laboratory values. Creatinine clearance in mL/min may be calculated from serum creatinine concentration by the Cockcroft-Gault (C-G) equation provided in the Protocol.
    19. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this study.
    E.5 End points
    E.5.1Primary end point(s)
    All-cause mortality
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Day 28
    E.5.2Secondary end point(s)
    1.Favorable clinical response at end of treatment (EOT) visit
    2.Favorable clinical response at early follow-up (EFU) visit
    3.Favorable microbiological response at EFU visit.
    4.Favorable microbiological response at EOT visit.
    5.Adverse Events
    6.Discontinuations due to adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.From treatment Day 7 up to Day 15
    2.7-14 days post-EOT (up to Day 28)
    3.7-14 days post-EOT (up to Day 28)
    4.From treatment Day 7 up to Day 15
    5.Up to Day 31
    6.Up to Day 14
    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 No
    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 EEA8
    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
    Brazil
    China
    France
    Mexico
    Philippines
    Romania
    Russian Federation
    Ukraine
    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
    LSLV
    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 months6
    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 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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 276
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-09
    P. End of Trial
    P.End of Trial StatusOngoing
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