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    Summary
    EudraCT Number:2019-003543-30
    Sponsor's Protocol Code Number:EORTC-1809-STBSG
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2019-003543-30
    A.3Full title of the trial
    A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma
    Randomizovaná studie fáze III s neodjuvantní chemoterapií s následnou operací versus operace samotná u pacientů s retroperitoneálním sarkomem vysokého rizika
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the effect of chemotherapy before surgery compared to surgery alone in patients with high risk retroperitoneal sarcoma
    Studie ověřující účinek chemoterapie před chirurgickým zákrokem v porovnání se samotným chirurgickým zákrokem u pacientů s vysoce rizikovým sarkomem retroperitonea
    A.3.2Name or abbreviated title of the trial where available
    STRASS 2
    STRASS 2
    A.4.1Sponsor's protocol code numberEORTC-1809-STBSG
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04031677
    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 SponsorEuropean Organisation for Research and Treatment of Cancer
    B.1.3.4CountryBelgium
    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 supportEuropean Organisation for the Research and Treatment of Cancer
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportAnticancer fund
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEuropean Organisation for the Research and Treatment of Cancer
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street Address83/11 Avenue E. Mounier
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3227741074
    B.5.5Fax number+3227727063
    B.5.6E-mailregulatory@eortc.org
    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 Yes
    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 nameDoxorubicin
    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 INNDOXORUBICIN HYDROCHLORIDE
    D.3.9.3Other descriptive namedoxorubicin
    D.3.9.4EV Substance CodeSUB01827MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.2.5The 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 nameEpirubicin
    D.3.4Pharmaceutical form Solution for injection/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 INNEpirubicin Hydrochloride
    D.3.9.1CAS number 56390-09-1
    D.3.9.3Other descriptive nameEPIRUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01915MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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: 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.2.5The 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 nameDacarbazin
    D.3.4Pharmaceutical form Solution for injection/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 INNDACARBAZINE
    D.3.9.1CAS number 4342-03-4
    D.3.9.4EV Substance CodeSUB06882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 1000
    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: 4
    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.2.5The 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 nameIfosfamide
    D.3.4Pharmaceutical form Powder for solution for injection/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 INNIFOSFAMIDE
    D.3.9.1CAS number 3778-73-2
    D.3.9.4EV Substance CodeSUB08125MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 5000
    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
    Primary high risk leiomyosarcoma or Liposarcoma of
    retroperitoneal space or infra-peritoneal spaces of pelvis
    E.1.1.1Medical condition in easily understood language
    Retroperitoneal sarcoma: a sarcoma developed in the back of the belly, next to the kidneys, in a relatively “hidden” location known as the retroperitoneum.
    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 10073135
    E.1.2Term Dedifferentiated liposarcoma
    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 10024189
    E.1.2Term Leiomyosarcoma
    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
    The primary objective of this study is to assess whether preoperative
    chemotherapy, as an adjunct to curative-intent surgery, improves the
    prognosis of patients with high risk de-differentiated liposarcoma
    (DDLPS) and leiomyosarcoma (LMS) as measured by disease-free
    survival.
    E.2.2Secondary objectives of the trial
    • To assess whether there is a difference in the overall survival,
    recurrence free survival, distant metastases free survival,
    cumulative incidence of local recurrences and cumulative
    incidence of distant metastases between patients undergoing
    curative-intent surgery alone and those undergoing preoperative
    chemotherapy followed by curative intent surgery
    • To assess tumour response in patients undergoing preoperative
    chemotherapy
    • To assess the toxicity profile of preoperative chemotherapy given
    as "neoadjuvant" treatment to curative intent surgery in patients
    with high risk retroperitoneal (RPS) and of surgery alone
    • To assess whether there is a difference in quality of life between
    patients undergoing curative-intent surgery alone and those
    undergoing preoperative chemotherapy followed by curative intent
    surgery
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically proven primary high risk leiomyosarcoma (LMS) or
    Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal
    spaces of pelvis.
    - LMS: * Grades 2 and 3 LMS of minimum size 5 cm
    - LPS (diagnosis based on MDM2 and CDK4 expression on
    IHC; additional proof of MDM2 amplification is highly
    recommended but not mandatory):
    * Grade 3 DDLPS OR
    * Confirmed grade 2 DDLPS on biopsy only if:
    FNCLCC score = 5 AND no necrosis on the biopsy but
    clear necrosis on imaging. OR
    * High risk gene profile as determined by the Complexity
    INdex in SARComas (CINSARC-high)
    • Unifocal tumour
    • Resectable tumour: resectability is based on pre-operative imaging
    performed within 28 days before randomization (CT-abdomen,
    potentially also with MRI) and has to be defined by the local
    treating sarcoma team. A patient is not considered resectable when
    the expectation is that only an R2 resection is feasible.
    Criteria for non-resectability are:
    - Involvement of the superior mesenteric artery, aorta,
    coeliac trunk and/or portal vein
    - Involvement of bone
    - Growth into the spinal canal
    - Progression of retro-hepatic inferior vena cava
    leimyosarcoma towards the right atrium
    - Infiltration of multiple major organs like liver, pancreas
    and or major vessels
    • Patient must have radiologically measurable disease (RECIST 1.1),
    as confirmed by imaging within the 28 days prior to
    randomization. CT thorax abdomen pelvis with IV contrast is the
    preferred imaging modality. In case of any contra-indications
    (medical or regulatory), it is allowed to perform a non-contrast CT
    thorax + MRI abdomen & pelvis.
    • ≥ 18 years old (no upper age limit)
    • WHO performance status ≤ 2
    • Adequate haematological and organ function assessed within 21
    days prior to randomization
    • American Society of Anesthesiologist (ASA) score < 3
    • Women of child bearing potential (WOCBP) must have a negative
    serum pregnancy test within 3 days prior to randomization.
    • WOCBP in both arms should use higly effective birth control
    measures, during the study treatment period and for at least 6
    months after the last dose of chemotherapy or date of surgery
    (except for women receiving chemotherapy with ifosfamide who
    should continue contraception until 1 year after last day of
    treatment). A highly effective method of birth control is defined as
    a method which results in a low failure rate (i.e. less than 1% per
    year) when used consistently and correctly.
    • For men in the experimental arm: agreement to remain abstinent
    (refrain from heterosexual intercourse) or use contraceptive
    measures, and agreement to refrain from donating sperm, as
    defined below:
    - With female partners of childbearing potential, men must
    remain abstinent* or use a condom plus an additional contraceptive method that together result in a failure rate of 1%
    per year during the treatment period and for 6 months after the
    last dose of chemotherapy. Men must refrain from donating
    sperm during this same period.
    - With pregnant female partners, men must remain abstinent* or
    use a condom during the treatment period and for 28 days after
    the last dose of chemotherapy to avoid exposing the embryo.
    • Female subjects who are breast feeding should discontinue nursing
    prior to the first day of study treatment and until 6 months after the
    last study treatment.
    • Before patient randomization, written informed consent must be
    given according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    • Sarcoma originating from bone structure, abdominal or
    gynecological viscera
    • Extension through the sciatic notch or across the diaphragm
    • Metastatic disease
    • Any previous surgery (excluding diagnostic biopsy), radiotherapy
    or systemic therapy for the present tumour
    • Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any
    of their metabolites or to any of their excipients
    • Congestive heart failure
    • Angina pectoris
    • Myocardial infarction within 1 year before randomization
    • Uncontrolled arterial hypertension defined as blood pressure ≥
    150/100 mm Hg despite optimal medical therapy
    • Uncontrolled cardiac arrhythmia
    • Previous treatment with maximum cumulative doses (450mg/m²
    Doxorubicin or equivalent 900mg/m² Epirubicin) of doxorubicin,
    daunorubicin, epirubicin, idarubicin, and/or other anthracyclines
    and anthracenediones
    • Active and uncontrolled infections
    • Vaccination with live vaccines within 30 days prior to study entry
    • Inflammation of the urinary bladder (interstitial cystitis) and/or
    obstructions of the urine flow.
    • Other invasive malignancy within 5 years, with the exception of
    adequately treated non-melanoma skin cancer, localized cervical
    cancer, localized and Gleason ≤ 6 prostate cancer.
    • Uncontrolled severe illness, infection,medical condition (including
    uncontrolled diabetes), other than the primary LPS or LMS of the
    retroperitoneum.
    • Female patients who are pregnant or breastfeeding or female and
    male pateints of reproductive potential who are not willing to
    employ effective birth control method.
    • Any psychological, familial, sociological or geographical
    condition potentially hampering compliance with the study
    protocol and follow-up schedule; those conditions should be
    discussed with the patient before randomization in the trial
    • Known contraindication to imaging tracer and to MRI
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (which includes as events: distant
    progression on neoadjuvant treatment, local progression if not
    followed by R0/R1 surgery, non-operable tumours, local
    recurrence and/or distant metastases, R2 and death)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease free survival will be evaluated 4 years after FPI (first interim look for futility), 5 years after FPI (second interim look for futility) and 7 years after FPI (final analysis)
    E.5.2Secondary end point(s)
    • Overall survival
    • Recurrence free survival
    • Distant metastases free survival
    • Cumulative incidence of local recurrences
    • Cumulative incidence of distant metastases
    • Radiological response to neoadjuvant chemotherapy according
    to RECIST
    • Radiological response to neoadjuvant chemotherapy according
    to CHOI
    • Pathological response
    • Safety and toxicity of neoadjuvant chemotherapy
    • Perioperative complications
    • Late complications
    • Health-Related Quality of life (EORTC QLQ-C30 + Item list
    from QLQ-STO22)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated at time of the final primary endpoint analysis: 7 years after FPI. A long term overall survival analysis will also be performed at later timepoint after EoT.
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    surgery alone
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Australia
    Canada
    Cyprus
    Czech Republic
    France
    Germany
    Italy
    Netherlands
    Poland
    Slovakia
    Spain
    Switzerland
    United Kingdom
    United States
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. Thirty days after all patients have stopped protocol treatment
    2. The trial is mature for the analysis of the primary endpoint as defined in the protocol
    3. The database has been fully cleaned and frozen for this analysis
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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: 163
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 250
    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)
    The treatment will be left to the discretion of the treating physician.
    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 Decision2020-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-12
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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