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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-004064-62
    Sponsor's Protocol Code Number:SNOXA12C401
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-08
    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 - BfArM
    A.2EudraCT number2018-004064-62
    A.3Full title of the trial
    Single-arm, dose-escalation Phase 1/2 Study of olaptesed pegol (NOX-A12) in combination with irradiation in inoperable or partially resected first-line glioblastoma patients with unmethylated MGMT promoter with a 3-arm expansion group including fully resected patients and combination with bevacizumab or pembrolizumab
    Eine einarmige, Dosis-Eskalations Phase 1/2 Studie von Olaptesed Pegol in Kombination mit Bestrahlung bei nicht resezierten oder teilresezierten Erstlinien-Glioblastom-Patienten mit unmethyliertem MGMT-Promotor mit einer dreiarmigen Erweiterungsgruppe einschließlich vollständig resezierter Patienten und Kombination mit Bevacizumab oder Pembrolizumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glioblastoma treatment with irradiation and olaptesed pegol in unmethylated patients
    Behandlung des Glioblastoms mit Bestrahlung und Olaptesed Pegol in unmethylierten Patienten
    A.3.2Name or abbreviated title of the trial where available
    GLORIA
    A.4.1Sponsor's protocol code numberSNOXA12C401
    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 SponsorTME Pharma AG
    B.1.3.4CountryGermany
    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 supportTME Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTME Pharma AG
    B.5.2Functional name of contact pointClinical Trial Disclosure Desk
    B.5.3 Address:
    B.5.3.1Street AddressMax-Dohrn-Str. 8-10
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10589
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930726247100
    B.5.6E-mailclinicaltrialdisclosuredesk@tmepharma.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1364
    D.3 Description of the IMP
    D.3.1Product nameOlaptesed pegol
    D.3.2Product code NOX-A12
    D.3.4Pharmaceutical form 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 INNOLAPTESED PEGOL
    D.3.9.1CAS number 1390628-22-4
    D.3.9.2Current sponsor codeNOX-A12
    D.3.9.4EV Substance CodeSUB189604
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number14.66
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MVASI 25 mg/mL concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Technology (Ireland) UC
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMVASI 25 mg/mL concentrate for solution for infusion
    D.3.4Pharmaceutical form 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.3.9.4EV 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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
    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 Yes
    D.2.1.1.1Trade name KEYTRUDA 25 mg/mL concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V. (The Netherlands)
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameKEYTRUDA 25 mg/mL concentrate for solution for infusion
    D.3.4Pharmaceutical form 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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    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 Yes
    D.3.11.13.1Other medicinal product typePembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
    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
    glioblastoma
    Glioblastom
    E.1.1.1Medical condition in easily understood language
    glioblastoma
    Glioblastom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety of either olaptesed pegol in combination with radiation therapy or olaptesed pegol combination with radiation therapy and bevacizumab or pembrolizumab in patients with newly diagnosed glioblastoma of unmethylated MGMT promoter status.
    E.2.2Secondary objectives of the trial
    - To explore the efficacy of olaptesed pegol in combination with radiation therapy on patients with glioblastoma
    - To investigate the efficacy of olaptesed pegol in combination with radiation therapy and bevacizumab or pembrolizumab in patients with glioblastoma of unmethylated MGMT promoter status
    - To investigate the pharmacokinetics of olaptesed pegol during continuous administration
    - To monitor symptoms (NANO) and Quality of Life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criteria for inclusion - Dose escalation cohorts:

    1. Written informed consent
    2. Age ≥18 years
    3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy (e.g., MGMT promotor analysis, cytogenetic markers such as IDH-1 mutations, etc.)
    4. Patient agrees to subcutaneous port implantation
    5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
    6. Status post biopsy or incomplete resection (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan)
    7. Unmethylated MGMT promoter status
    8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
    9. Estimated minimum life expectancy 3 months
    10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
    11. The following laboratory parameters should be within the ranges specified:
    • Total bilirubin ≤ 1.5 x upper limit normal (ULN)
    • Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
    • ALT (alanine transaminase) ≤ 3 x ULN
    • AST (aspartate transaminase) ≤ 3 x ULN
    12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
    13. Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP


    Criteria for inclusion - Expansion Group:

    1. Written informed consent
    2. Age ≥ 18 years
    3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained during the preceding surgery or biopsy (e.g., MGMT promoter analysis, cytogenetic markers such as IDH-1 mutations, etc.)
    4. Patient agrees to subcutaneous port implantation
    5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
    6. a) Status post biopsy or incomplete resection (detectable residual tumor as per postoperative T1-weighted, contrast-enhanced MRI scan) or complete resection (Arm A)
    OR
    b) Status post complete resection (Arm B)
    OR
    c) Status post complete or incomplete resection (circumscribed enhancing tumor ≤ 5.0 cm in largest diameter as per postoperative T1-weighted, contrast-enhanced MRI scan) (Arm C)
    7. Unmethylated MGMT promoter status
    8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
    9. Estimated minimum life expectancy 3 months
    10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
    11. The following laboratory parameters should be within the ranges specified:
    • Total bilirubin ≤ 1.5 x upper limit normal (ULN)
    • Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
    • ALT (alanine transaminase) ≤ 3 x ULN
    • AST (aspartate transaminase) ≤ 3 x ULN
    12. Female patients of child-bearing potential must have a negative serum pregnancy test within 21 days prior to enrollment and agree to use a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly such as contraceptive implants, vaginal rings, sterilization, or sexual abstinence) during and for 3 months (6 months Arm A, 4 months Arm C) following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations)
    13. Male patients must use an effective barrier method of contraception during study and for 3 months (6 months Arm A, 4 months Arm C) following the last dose if sexually active with a FCBP
    E.4Principal exclusion criteria
    All patients
    • Cytostatic therapy (chemotherapy) within the past 5 years
    • History of other cancers (except for adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the patient was disease-free for ≥ 5 years)
    • Prior radiotherapy to the head
    • Any other previous or concomitant experimental glioblastoma treatments
    • Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
    • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, chronic liver disease (e.g., cirrhosis, hepatitis), diabetes mellitus, or subjects with either of the following: fasting blood glucose (FBG defined as fasting for at least 8 hours) ≥ 200 mg/dL (7.0 mmol/L), or HbA1c ≥ 8%, chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness/social situations that would limit compliance with study requirements. Patients must be free of any clinically relevant disease (other than glioma) that would, in the treating investigator's opinion, interfere with the conduct of the study or study evaluations
    • Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
    Dose Escalation Cohorts
    • Clinically significant or uncontrolled cardiovascular disease, including, Myocardial infarction in the previous 12 months, Uncontrolled angina, Congestive heart failure (New York Heart Association functional classification of ≥2), Diagnosed or suspected congenital long QT syndrome, QTc prolongation on an electrocardiogram prior to entry (>470 ms), Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg), Heart rate <50/min on the baseline electrocardiogram, History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes)

    Arms A and B
    • Planned hypofractionated radiotherapy
    • Secondary malignancy which is currently active
    • Clinically significant or uncontrolled cardiovascular disease, including Myocardial infarction in the previous 12 months, Uncontrolled angina, Congestive heart failure (New York Heart Association functional classification of ≥2), Diagnosed or suspected congenital long QT syndrome, QTc prolongation on an electrocardiogram prior to entry (>470 ms), Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg), Heart rate <50/min on the baseline electrocardiogram, History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes), Cerebrovascular accident
    • Patients with a history of arterial or venous thrombosis (or any other disease) requiring permanent intake of anticoagulants (Arm A only)
    • Prolongation of coagulation factors ≥ 2.5 x ULN (Arm A only)

    Arm C
    • Biopsy-only of GBM with less than 20% of tumor removed
    • Presence of extracranial metastatic or leptomeningeal disease
    • Severe hypersensitivity (≥ Grade 3) to other monoclonal antibodies
    • Receiving immunosuppressive therapy
    • Previous or current treatment with an anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PDL2 agent
    • Planned hypofractionated radiotherapy
    • Clinically significant or uncontrolled cardiovascular disease, including Myocardial infarction in the previous 12 months, Uncontrolled angina, Congestive heart failure (New York Heart Association functional classification of ≥2), Diagnosed or suspected congenital long QT syndrome, QTc prolongation on an electrocardiogram prior to entry (>470 ms), Uncontrolled hypertension (blood pressure ≥ 160/95 mmHg), Heart rate <50/min on the baseline electrocardiogram, History of ventricular arrhythmias of any clinically significant type (such as ventricular tachycardia, ventricular fibrillation or torsades de pointes), Cerebrovascular accident
    • Evidence of acute intracranial / intra-tumoral hemorrhage
    • Received a live vaccine within 30 days prior to the first dose of study drug.
    • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Previously treated brain metastases may participate provided these remain stable
    • Known history of HIV infection, hepatitis B or hepatitis C infection
    • Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
    • History of (non-infectious) pneumonitis / interstitial lung disease that required steroids or current pneumonitis / interstitial lung disease
    • Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (exceeding 10 mg daily of prednisone) or any other form of immunosuppressive therapy
    • High dose of corticosteroids (> 4mg/day of dexamethasone or equivalent for at least 3 consecutive days) within two weeks prior to the first dose of study drug
    • Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Adverse Events
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    E.5.2Secondary end point(s)
    • Progression Free Survival (PFS) at 6 months (PFS-6)
    • Median progression-free survival (mPFS)
    • Median overall survival (mOS)
    • Tumor vascularisation as per vascular MRI scans at baseline and following 2, 4, and 6 months
    • Topography of recurrence
    • Determination of maximum tolerated dose (MTD)
    • Definition of recommended Phase 2 dose (RP2D)
    • Olaptesed pegol plasma levels at steady state
    • Neurologic Assessment in Neuro-Oncology (NANO) assessment
    • Quality of Life
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose escalation study
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single arm, dose escalation, combination therapy with irradiation /Bevacizumab / Pembrolizumab
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state27
    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)
    After the planned treatment period of the study has ended, no further olaptesed pegol will be provided for patients.
    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 Decision2019-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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