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    Summary
    EudraCT Number:2016-001166-29
    Sponsor's Protocol Code Number:inims-009
    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:2019-08-12
    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 number2016-001166-29
    A.3Full title of the trial
    A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)
    Eine randomisierte kontrollierte Studie zum Vergleich von Ocrelizumab oder Alemtuzumab mit autologer hämatopoetischer Stammzelltransplantation (aHSCT) bei hoch entzündlicher Multipler Sklerose (COAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)
    Eine randomisierte kontrollierte Studie zum Vergleich von Ocrelizumab oder Alemtuzumab mit autologer hämatopoetischer Stammzelltransplantation (aHSCT) bei hoch entzündlicher Multipler Sklerose (COAST)
    A.3.2Name or abbreviated title of the trial where available
    COAST
    A.4.1Sponsor's protocol code numberinims-009
    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 SponsorUniversity Medical Centre Hamburg-Eppendorf
    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 supportNeovii Pharmaceuticals AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Hamburg-Eppendorf
    B.5.2Functional name of contact pointNicolaus Kroeger
    B.5.3 Address:
    B.5.3.1Street AddressMartinistrasse 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number0049040741054851
    B.5.5Fax number0049040741053795
    B.5.6E-mailn.kroeger@uke.de
    D. IMP Identification
    D.IMP: 1
    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 Lemtrada
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Belgium
    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 namealemtuzumab
    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 INNalemtuzumab
    D.3.9.1CAS number 216503-57-0
    D.3.9.3Other descriptive nameALEMTUZUMAB
    D.3.9.4EV Substance CodeSUB12459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 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 Ocrevus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameocrelizumab
    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 INNocrelizumab
    D.3.9.3Other descriptive nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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: 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 nameautologous hematopoietic stem cells
    D.3.2Product code aHSC
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 Yes
    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
    relapsing-remitting multiple sclerosis
    schubförmig remittierende Multiple Sklerose
    E.1.1.1Medical condition in easily understood language
    multiple sclerosis with relapses that are followed by periods of partial or complete recovery
    Multiple Sklerose, die in einzelnen Schüben verläuft, welche sich vollständig oder unvollständig zurückbilden
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To gain further evidence for clinical efficacy of aHSCT in active RRMS compared to ocrelizumab or alemtuzumab
    2. To gain further knowledge on safety, tolerability and toxicity of aHSCT in MS
    1. Weitere Evidenz für die klinische Wirksamkeit der aHSCT im Vergleich zu Ocrelizumab oder Alemtuzumab
    2. Weitere Kenntnisse zur Sicherheit, Verträglichkeit und Toxizität der aHSCT bei MS
    E.2.2Secondary objectives of the trial
    1. To gain further knowledge on the quality of life, daily functioning and long-term disability of patients treated with aHSCT with a special focus on neurocognitive functioning and on MRI measurements of neurodegeneration
    2. To gain further knowledge on negative and positive predictors for aHSCT response in MS
    1. Weitere Erkenntnisse zur Lebensqualität, Aktivitäten des täglichen Lebens und zur langfristigen Beeinträchtigung – mit einem Fokus auf Kognition und Neurodegeneration in der MRT
    2. Weitere Kenntnisse zu negativen und positiven Prädiktoren für ein Ansprechen auf die aHSCT gewinnen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and agreement to comply to study protocol
    2. Age: 18-55 years
    3. EDSS: 0.0 – 6.0
    4. RRMS according to McDonald 20108
    5. < 10 years of disease course after symptom onset
    6. Active disease with one of the following treatment failures occurring not earlier than 6 months after initiation of an approved DMT:
    - 2 or more relapses within the last 12 months
    or
    - 1 relapse within the last 12 months and a Gd-enhancing lesion on MRI > 3 mm > 3 months before or after relapse onset or 2 new T2-lesions
    or
    - On-going signs of MRI activity in the last 6 months (either Gd-enhancing of ≥ 3 mm lesion at any exam in the last year; or more than 5 new T2 lesions (≥ 3 mm))
    or
    - Patients stable under natalizumab but who have to stop treatment due to an increasing PML risk are defined as active, if a MRI within 6 months after termination of natalizumab shows new T2 or Gd-enhancing lesions and at least one other treatment failure prior to natalizumab is documented
    1. Schriftliche und informierte Einwilligung zum Studienprotokoll
    2. Alter: 18-55 years
    3. EDSS: 0.0 – 6.0
    4. Schubförmige MS nach McDonald 20108
    5. < 10 Jahre Krankheitsdauer nach den ersten Symptomen
    6. Aktive MS mit Nachweis eines Therapieversagen entsprechend den folgenden Kriterien und frühestens sechs Monate nach Beginn der Behandlung mit einem zugelassenen Medikament:
    - 2 oder mehr Schübe in den letzten 12 Monaten
    oder
    - 1 Schub in den letzten 12 Monaten in Kombination mit einer KM-aufnehmenden Läsion in der MRT (≥ 3 mm) mindestens drei Monate vor oder nach zum Schubbeginn oder 2 neuen T2-Läsionen
    oder
    - Anhaltende Zeichen von Krankheitsaktivität in der MRT über 6 Monate: entweder KM-Läsionen ≥ 3 mm im letzten Jahr oder mehr als 5 neue T2 Läsionen (≥ 3 mm)
    oder
    - Patienten, die stabil unter Natalizumab waren und die Behandlung wegen eines steigenden PML-Risikos beenden mussten, wenn innerhalb von 6 Monaten nach Therapieende neue Läsionen (KM oder T2) in der MRT nachweisbar sind und mindestens unter einem anderen Medikament zuvor ein Therapieversagen dokumentiert wurde
    E.4Principal exclusion criteria
    1. Secondary or primary progressive MS
    2. Pregnancy, or other medical condition incompatible with aHSCT
    3. Any treatment or medical condition that, according to the haematologist / transplant specialist precludes the use of aHSCT
    4. John Cunningham virus (JCV) antibody index of > 1.5 in previously natalizumab-treated patients, if a negative CSF JCV-PCR prior to screening is not available
    5. Relapse during 30 days before initiation of treatment. If a relapse occurs during this period and eligibility criteria are otherwise fulfilled, start of treatment will be delayed until at least 30 days after receiving steroids.
    6. Concurrent clinically significant (as determined by the investigators and haematologist / transplant specialist) cardiac, immunological, pulmonary, neurological, renal or other major disease such as:
    - Prominent cardial disease (Left ventricular ejection fraction (LVEF) < 40%, myocardial infarction or ischemia, uncontrolled arrhythmias, pericardial effusions > 1 cm)
    - Cerebrovascular disease
    - Renal disease (creatinine clearance < 30 ml/min/m2)
    - Respiratory disease (DLCO < 40% predicted)
    - Active bleeding or clotting disease
    - History of human immunodeficiency virus (HIV) or positive HIV antibody testing
    - Any uncontrolled acute or chronic infection, including HIV, hepatitis B surface antigen positivity and hepatitis C PCR positivity
    - Cancer except in situ cervix or cutaneous
    7. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule. Unwillingness to use contraception.
    8. Previous participation in this study, previous treatment with aHSCT or already both comparators
    9. Ongoing immunotherapy. Treatment with interferon or glatirameracetate will need no wash-out. Treatment pause before ocrelizumab/alemtuzumab or aHSCT will be:
    - for dimethylfumarate and fingolimod: 8 weeks
    - for natalizumab: 8 weeks
    - for ocrelizumab: 12 weeks
    - for alemtuzumab: 12 months
    - for teriflunomide: 4 weeks after elimination with cholestyramine
    - for cladribine: 24 weeks
    10. Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
    1. Sekundär oder primär chronisch-progressive MS
    2. Schwangerschaft, oder andere gesundheitliche Zustände, die nicht mit einer aHSCT vereinbar sind
    3. Behandlungen oder Erkrankungen, die nach Maßgabe des Hämatologen / Transplanteurs eine aHSCT ausschließen
    4. John Cunningham Virus (JCV) Antikörperindex > 1.5 in Patienten, die zuvor mit Natalizumab behandelt wurden und bei denen keine aktuelle negative JCV-PCR aus dem Liquor vorliegt
    5. Ein Schub in den letzten 30 Tagen vor Behandlungsbeginn im Rahmen der Studie. Bei Einem Schub in Screeningphase wird der Behandlungsbeginn um 30 Tage nach der letzten Cortisongabe verschoben.
    6. Anderweitige schwerwiegende kardiale, immunologische, pulmonale, neurologische, renale oder anderweitige Erkrankung (auf Basis der Einschätzung der Studienärzte und der Hämatologen / Transplanteure). Zum Beispiel:
    - Fortgeschrittene Herzerkrankung (Linksventrikuläre Ejejtionsfraktion (LVEF) < 40%, unkontrollierbare ventrikuläre Arrhythmien, Herzinfarkt oder kardiale Ischämie, Pericardergüsse > 1 cm)
    - Zerebrovaskuläre Erkrankungen
    - Nierenerkrankungen mit creatinine clearance < 30 ml/min/m2
    - Lungenerkrankungen mit DLCO < 40%
    - Akute Blutungen oder Gerinnungserkrankungen
    - Unkontrollierbare akute oder chronische Infektionen, einschließlich HIV, positivem Hepatitis B Oberflächen Antigen und positiver Hepatitis C PCR
    - Krebserkrankungen, ausgenommen in situ des Cervix oder der Haut
    7. Unwillen oder Unfähigkeit die Anforderungen des Protokolls zu erfüllen sowie physische, mentale oder soziale Begleitumstände, die eine termingerechte Vorstellung zu Follow-up-Visiten unwahrscheinlich machen. Verweigerung einer ausreichenden Kontrazeption.
    8. Vorherige Teilnahme an dieser Studie oder vorherige Behandlung mit aHSCT oder bereits beiden Kontrollbehandlungen
    9. Weitergeführte Immuntherapie. Vorherige Behandlungen mit Interferonen oder Glatirameracetat benötigen kein wash-out. Für andere Immuntherapien gelten die folgenden Behandlungspausen vor Beginn der Behandlung mit Ocrelizumab/Alemtuzumab oder aHSCT:
    - für Dimethylfumarat und Fingolimod: 8 Wochen
    - für Natalizumab: 8 Wochen
    - für Ocrelizumab: 12 Wochen
    - für Alemtuzumab: 12 Monate
    - für Teriflunomide: 4 Wochen nach Elimination mit Cholestyramine
    - für Cladribin: 24 Wochen
    10. Patienten mit kognitiven Einschränkungen, die nicht in der Lage sind eine informierte schriftliche Entscheidung zu treffen. Dies betrifft auch Screening- und Baseline-Untersuchungen, die nicht im Rahmen der Regelversorgung erfolgen würden.
    E.5 End points
    E.5.1Primary end point(s)
    Time to treatment failure as assessed by failure of NEDA (no evidence of disease) activity during follow-up as defined by:
    a. 3 months confirmed EDSS progression
    b. confirmed relapse
    c. new/enlarging T2-hyperintense lesion on MRI
    d. any Gd-enhancing lesion on MRI
    Zeit bis zum Auftreten von Krankheitsaktivität während der Beobachtungszeit definiert als Versagen von NEDA (no evidence of disease activity) mit:
    a. EDSS-Verschlechterung (bestätigt nach drei Monaten)
    b. Schub
    c. neue oder vergrößerte T2- Läsion in der MRT
    d. Kontrastmittel aufnehmende Läsion in der MRT
    E.5.1.1Timepoint(s) of evaluation of this end point
    a. after 3 months
    b., c., d. after 6, 12, 18 and 24 months; after that every 6 months until last patient has 24 months of follow-up
    a. nach 3 Monaten
    b., c., d. nach 6, 12, 18 und 24 Monaten; danach alle 6 Monate bis der letzte Patient 24 Monate Follow-up erreicht hat
    E.5.2Secondary end point(s)
    Efficacy:
    a. EDSS change and EDSS improvement
    b. Annualized relapse rate
    c. Number of new T2 lesions
    d. Number of Gd-enhancing lesions
    e. Multiple sclerosis functional composite (MSFC) change
    f. Hamburg quality of life scale in MS (HAQUAMS)
    g. Percentage Brain Volume Change (PBVC)
    h. Grey and white matter atrophy
    Safety:
    a. Rate of AE / SAE including NCI grade 3 and 4 non-haematological toxicities
    Wirksamkeit:
    a. EDSS-Veränderung und EDSS-Verbesserung
    b. Jährliche Schubrate
    c. Anzahl neuer T2 Läsionen
    d. Anzahl Kontrastmittel aufnehmender Läsionen
    e. Veränderung im Multiple sclerosis functional composite (MSFC)
    f. Lebensqualität gemessen mit der Hamburg quality of life scale in MS (HAQUAMS)
    g. Prozentuale Hirnvolumenänderung (PBVC)
    h. Atrophie der grauen und weißen Substanz
    Sicherheit:
    a. Rate der AE / SAE
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 6, 12, 18 and 24 months; after that every 6 months until last patient has 24 months of follow-up
    nach 6, 12, 18 und 24 Monaten; danach alle 6 Monate bis der letzte Patient 24 Monate Follow-up erreicht hat
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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 concerned4
    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 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 years4
    E.8.9.1In the Member State concerned months1
    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: 50
    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 state50
    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
    Keine
    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 Decision2020-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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