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    Summary
    EudraCT Number:2017-000202-37
    Sponsor's Protocol Code Number:AGO-OVAR2.29
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-05
    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 ConcernedGermany - PEI
    A.2EudraCT number2017-000202-37
    A.3Full title of the trial
    Atezolizumab in combination with Bevacizumab and Chemotherapy versus Bevacizumab and Chemotherapy in recurrent ovarian cancer – a randomized Phase III trial
    Atezolizumab in Kombination mit Bevacizumab und Chemotherapie versus Bevacizumab und Chemotherapie beim rezidivierendem Ovarialkarzinom – eine randomisierte Phase III Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of treatment combination Atezolizumab/Bevacizumab +/- Chemotherapy in patients with recurrent ovarian cancer
    A.4.1Sponsor's protocol code numberAGO-OVAR2.29
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03353831
    A.5.4Other Identifiers
    Name:ENGOTNumber:ov-34
    Name:EudraCT No.Number:2017-000202-37
    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 SponsorAGO Research GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAGO Research GmbH
    B.5.2Functional name of contact pointStudy Office
    B.5.3 Address:
    B.5.3.1Street AddressMoltkeplatz 63
    B.5.3.2Town/ cityEssen
    B.5.3.3Post code45138
    B.5.3.4CountryGermany
    B.5.4Telephone number004920195981211
    B.5.5Fax number004920195981221
    B.5.6E-mailncron@ago-ovar.de
    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 nameAtezozlizumab
    D.3.2Product code RO5541267
    D.3.4Pharmaceutical form 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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH (RGG), Grenzach-Whylen, Germany
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBevacizumab
    D.3.2Product code RO4876646
    D.3.4Pharmaceutical form Concentrate for concentrate 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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Efficacy of atezolizumab in combination with non-platinum based chemotherapy and bevacizumab versus the combination of a non-platinum based chemotherapy and bevacizumab in recurrent ovarian cancer
    E.1.1.1Medical condition in easily understood language
    Efficacy of atezolizumab and bevacizumab in patients with recurrent ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10016182
    E.1.2Term Fallopian tube cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall survival (OS), defined as the time from randomi-zation to death from any cause
    Progression free survival (PFS) defined as the time from randomization to progressive disease (PD) or death, which-ever occurs earlier. PD is based on investigator assess-ment using the Response Evaluation Criteria in Solid Tu-mors (RECIST v1.1)
    E.2.2Secondary objectives of the trial
    •QoL/PROs including predefined subgroups (symptomatic vs asymptomatic) and subdo-mains (EORTC C-30, OV28, PRO-CTCAE) and time until definitive deterioration (TUDD) including
    • To evaluate PROs of function and HRQoL associated with atezolizumab versus placebo in combination with non-platinum based chemotherapy + bevacizumab, as meas-ured by the functional and HRQoL scales of the EORTC QLQ-C30
    • To evaluate overall response rate (ORR) and duration of response (DOR)
    • Efficacy regarding OS, PFS, ORR/DOR depending on PD-L1 status present vs absent and T eff cell signature high vs low (This might be amended as there is at the moment no clear definition feasible of the optimal PDL-1 and T eff cell signature status of a “target” population)
    • To evaluate safety and tolerability of atezolizumab versus placebo in combination with non-platinum chemotherapy + bevacizumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer
    2. Relapsed disease
    3. Patients with up to three prior therapies. In patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months; in addition patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines are also eligible
    4. Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression
    5. Patient agrees and is able to provide a recent tumor biopsy (not older than 3 months) or agrees and has a tumor lesion amenable for taking a new tumor biopsy.
    6. Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)
    7. Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line
    8. Patients previously treated with bevacizumab are eligible, with the exclusion of those patients that has suspended bevacizumab for more than 2 subsequent cycles or permanently discontinued bevacizumab during their previous treatment due to toxicity. A washout period of at least 20 days after last bevacizumab treatment must be adhered.
    9. Females aged ≥ 18 years at signing at time of signing informed consent form
    10. Signed written informed consent and ability to comply with the study protocol, in the investigator’s judgement
    11. Adequate hematological, renal and hepatic function within 28 days prior to first admin-istration of study treatment:
    Hemoglobin ≥ 9.0 g/dl
    - Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L
    - Platelet count ≥ 100 x 10E9/L
    - Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
    - Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase /Serum Glutamic Pyruvate Transam-inase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN
    - Serum creatinine ≤ 1.5 x institutional ULN
    - Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of ran-domization
    - Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours.
    12. Patients must have adequately controlled blood pressure (BP), with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study.
    13. Estimated life expectancy of at least 3 months
    14. ECOG performance status 0 – 1
    15. Negative urine or serum pregnancy test within 7 days of study treatment in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1
    16. For women of childbearing potential: agreement to remain abstinent (refrain from het-erosexual inter-course) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later.
    17. For countries where this will apply to: a patient will be eligible for randomization in this study only, if either affiliated to, or a beneficiary of a social security category.
    18. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, that include the completion of patient-reported out-comes questionnaires.
    E.4Principal exclusion criteria
    1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum
    2. Ovarian tumors of low malignant potential
    3. Malignancies other than ovarian cancer within 5 years prior to randomisation.
    4. More than three prior systemic anticancer regimens; maintenance therapies are not calculated as separate line.
    5. Prior systemic anticancer therapy within 28 days before randomization.
    6. Prior radiotherapy to the pelvis or the abdomen.
    7. Administration of other simultaneous chemotherapy drugs, any other anticancer ther-apy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period.
    8. Prior treatment with anti-CD137 or immune checkpoint blockade therapies, anti-PD1, or anti-PD-L1 therapeutic antibodies or anti-CTLA 4
    9. Prior randomization in AGO-OVAR 2.29.
    10. Treatment with systemic immunostimulatory agents (including but not limited to inter-feron-alpha and interleukin-2 within 4 weeks or five half-lives of the drug (whichever is longer) prior to Cycle 1, Day 1
    11. Treatment with systemic corticosteroids or other systemic immunosuppressive medi-cations within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial. The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineral-ocorticoids.
    12. Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have screening and subsequent tumor assessments performed using MRI.
    13. Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1, day 1 or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab/placebo.
    14. Major surgery within 4 weeks of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.
    15. Previous allogeneic bone marrow transplant or previous solid organ transplantation.
    16. Current treatment with anti-viral therapy for HBV.
    17. History of idiopathic pulmonary fibrosis (including pneumonitis), organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted
    18. Previous Cerebro-Vascular Accident, Transient Ischemic Attack or Sub-Arachnoids Hemorrhage within 6 months prior to randomization
    19. History or evidence of thrombotic or hemorrhagic disorders within 6 months prior to randomization
    20. History or clinical suspicion of brain metastases or spinal cord compression.
    21. History of autoimmune disease
    22. Any prior history of hypertensive crisis (CTCAE grade 4) or hypertensive encephalopathy
    23. Immunocompromised patients
    24. Persistent toxicities (≥ CTCAE grade 2)
    25. Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization
    26. Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day
    27. Clinically significant cardiovascular disease
    28. For patients with PLD treatment: Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal
    29. Evidence of bleeding diathesis or significant coagulopathy
    30. Non-healing wound, active ulcer or bone fracture
    31. History of bowel obstruction related to underlying disease, a history of abdominal fistula, GI perforation, or intra-abdominal abscess, or evidence of deep infiltration of the bowel by pelvic examination or on computed tomography, or clinical symptoms of bowel obstruction
    32. Patients with evidence of abdominal free air
    33. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications
    34. Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    35. Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, paclitaxel, pegylated liposomal doxorubicin, or their excipients that contraindicates the subject’s participation.
    36. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.
    37. Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS)
    Progression-free Survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 391 OS events have been observed
    at least 547 PFS events should be observed in the same time
    E.5.2Secondary end point(s)
    Quality of Life (QoL) and Patient Reported Outcome (PRO)
    Evaluation of Overall Response Rate (ORR) and Duration of Response (DOR)
    Evaluation of Safety and Tolerability of Atezolizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Quality of Life (QoL) and Patient Reported Outcome (PRO) every 4 weeks during the first 3 months, then every 12 weeks
    Evaluation of Overall Response Rate (ORR) and Duration of Response (DOR) every 12 weeks until disease progression
    Evaluation of Safety and Tolerability of Atezolizumab at every visit
    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 No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Paclitaxel, Pegylated Liposomal Docorubicin
    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 concerned60
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    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 years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 442
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 222
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-12-05. Yes
    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 state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 664
    F.4.2.2In the whole clinical trial 664
    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)
    According local standard for each institution.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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