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    Summary
    EudraCT Number:2022-001612-25
    Sponsor's Protocol Code Number:REP0122
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-001612-25
    A.3Full title of the trial
    Phase 2, proof-of-concept, randomized, double-blinded, placebo-controlled, multicenter study to assess efficacy and safety of reparixin as add-on therapy to standard of care in adult patients with Acute Respiratory Distress Syndrome (RESPIRATIO)
    Studio di fase II, multicentrico, randomizzato, proof-of-concept, in doppio cieco e controllato con placebo volto a valutare l'efficacia e la sicurezza di reparixin come terapia aggiuntiva allo standard di cura in pazienti adulti con sindrome da distress respiratorio acuto (RESPIRATIO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2, randomized, double-blinded, placebo-controlled, multicenter study to assess efficacy and safety of reparixin as additional therapy in adult patients with Acute Respiratory Distress Syndrome
    Studio di fase II, multicentrico, randomizzato, in doppio cieco e controllato con placebo volto a valutare l'efficacia e la sicurezza di reparixin come terapia aggiuntiva in pazienti adulti con sindrome da distress respiratorio acuto
    A.3.2Name or abbreviated title of the trial where available
    Reparixin in Acute Respiratory Distress Syndrome (ARDS)
    Reparixin nella sindrome da distress respiratorio acuto (ARDS)
    A.4.1Sponsor's protocol code numberREP0122
    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 SponsorDOMPé FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    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 supportDompè farmaceutici s.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDompé farmaceutici s.p.a.
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia Santa Lucia 6
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number+39023408825229
    B.5.6E-mailgiovanna.dituri@dompe.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameReparixin
    D.3.2Product code [DF 1681Y]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREPARIXIN
    D.3.9.1CAS number 266359-83-5
    D.3.9.2Current sponsor codeDF 1681Y
    D.3.9.4EV Substance CodeSUB130481
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Respiratory Distress Syndrome
    Sindrome da distress respiratorio acuto
    E.1.1.1Medical condition in easily understood language
    Serious lung condition that causes low blood oxygen
    Grave condizione polmonare che causa un basso livello di ossigeno nel sangue
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the efficacy of reparixin in ameliorating lung injury and systemic inflammation and expediting clinical recovery and liberation from mechanical ventilation of adult patients with moderate to severe ARDS (PaO2/FIO2 ratio less than or equal to 200). Furthermore, to characterize the PK of reparixin in this group of severely ill patients as well as the effect of reparixin on systemic biomarkers linked to a hyper-inflammatory ARDS phenotype29-31.
    Safety objectives: To evaluate the safety of reparixin versus placebo in the specific clinical setting, including the effect on the incidence of secondary infections.
    Caratterizzare l'efficacia di reparixin nel miglioramento del danno polmonare e dell'infiammazione sistemica e nell'accelerare il recupero clinico e l'abbandono della ventilazione meccanica in pazienti adulti affetti da sindrome da distress respiratorio acuto (Acute Respiratory Distress Syndrome, ARDS) da moderata a grave (rapporto PaO2/FIO2 < o = a 200). Inoltre, caratterizzare la farmacocinetica (Pharmacokinetics, PK) di reparixin nella stessa popolazione di pazienti con malattia acuta arruolati nello studio e valutare l'effetto di reparixin sui biomarcatori sistemici legati a un fenotipo iperinfiammatorio di ARDS fenotipo 29-31.
    Obiettivi di sicurezza: Valutare la sicurezza di reparixin rispetto al placebo nello specifico contesto clinico, includendo l'effetto sull'incidenza di infezioni secondarie.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed Informed Consent, according to local guidelines and regulation
    2. Adults ( > or =18 years old).
    3. Mechanically ventilated (invasive) patients with PaO2/FIO2 ratio less than or equal to 200 in the presence of PEEP of > or = to 5 mmHg.
    4. Respiratory failure not fully explained by cardiac failure or fluid overload (if acute Congestive Heart Failure exacerbation is identified as part of the clinical picture this should be addressed effectively and as soon as possible before the patient can be enrolled).
    5. Bilateral radiologic opacities consistent with pulmonary edema on the frontal chest x-ray (CXR), or bilateral ground glass opacities on a chest computerized tomography (CT) scan.
    6. less than or equal to 48 hours from fulfilling above ARDS criteria.
    7. less than or equal to 7 days from hospital admission.
    8. Females of child-bearing potential who are sexually active must be willing not to get pregnant within 30 days after the last IMP dose and must agree to at least one of the following reliable methods of contraception:
    a. Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives from at least 2 months before the screening visit until 30 days after the last IMP dose;
    b. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide from at least 2 months before the screening visit until 30 days after the last IMP dose;
    c. A male sexual partner who agrees to use a male condom with spermicide;
    d. A sterile sexual partner;
    e. Abstinence.
    Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects with child-bearing potential, pregnancy test result must be negative before first drug intake.
    1. Consenso informato firmato, secondo le linee guida e le normative locali.
    2. Adulti (di età > or =18 anni).
    3. Pazienti con ventilazione meccanica (invasiva) con rapporto PaO2/FIO2 < o = a 200 in presenza di PEEP > o = a 5 mmHg.
    4. Insufficienza respiratoria non completamente spiegata da insufficienza cardiaca o sovraccarico di liquidi (se viene individuata una riacutizzazione dell'insufficienza cardiaca congestizia nell'ambito del quadro clinico, questa deve essere affrontata in modo efficace e il prima possibile prima che il paziente possa essere arruolato).
    5. Opacità radiologiche bilaterali compatibili con edema polmonare sulla radiografia RXT frontale o opacità bilaterali a vetro smerigliato su una TC del torace.
    6. < o = 48 ore dal soddisfacimento dei criteri ARDS di cui sopra.
    7. < o = 7 giorni dal ricovero in ospedale.
    8. Le donne in età fertile che sono sessualmente attive devono essere disposte a non iniziare una gravidanza entro i 30 giorni successivi all'ultima dose del medicinale sperimentale (IMP) e devono accettare di utilizzare almeno uno dei seguenti metodi contraccettivi affidabili:
    a. Contraccettivi ormonali, sistemici, impiantabili, transdermici o iniettabili da almeno 2 mesi prima della visita di screening fino a 30 giorni dopo l'ultima dose di IMP
    b. Un dispositivo intrauterino non ormonale o un preservativo femminile con spermicida o spugna contraccettiva con spermicida o diaframma con spermicida o cappuccio cervicale con spermicida da almeno 2 mesi prima della visita di screening fino a 30 giorni dopo l'ultima dose di IMP;
    c. Un partner sessuale maschile che accetta di usare un preservativo maschile con spermicida;
    d. Partner sessuale sterile
    e. Astinenza
    Saranno ammesse donne non in età fertile o in postmenopausa da almeno 1 anno. Per tutti i soggetti di sesso femminile in età fertile, il risultato del test di gravidanza deve essere negativo prima della prima assunzione del farmaco.
    E.4Principal exclusion criteria
    1. Severe chronic hepatic disease (as verified by relevant history, imaging if pre-existent and ChildPugh score 12-15).
    2. Severe chronic renal dysfunction: eGFR (MDRD) <30 mL/min/1.73m2 or End Stage Renal Disease on renal replacement therapy.
    3. Participation in another interventional clinical trial.
    4. Patients that are clinically determined to have a high likelihood of death within the next 24 hours based on PI’s estimation.
    5. Evidence of anoxic brain injury.
    6. Currently receiving ECMO or high frequency oscillatory ventilation.
    7. Anticipated extubation within 24 hours of enrollment.
    8. Active malignancy (with the exception of non-melanotic skin cancers).
    9. Hemodynamic instability (>30% increase in vasopressors in the last 6 hours or norepinephrine > 0.5 mcg/Kg/min).
    10. Evidence of gastrointestinal (GI) dysmotility e.g., due to acute pancreatitis or immediate post-op state, as demonstrated by persistent gastric distention, enteral feeding intolerability and/or persistent gastric residuals >500 ml).
    11. Anticipated discharge from the hospital or transfer to another hospital within 72 hours of screening.
    12. Decision to withhold or withdraw life-sustaining treatment (patients may still be eligible however if they are committed to full support except cardiopulmonary resuscitation if cardiac arrest occurs)
    13. History of:
    a) Documented allergy to more than one medication belonging to the class of sulfonamides, such as sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib (hypersensitivity to sulphanilamide antibiotics alone, e.g., sulfamethoxazole does not qualify for exclusion), and to the study product and/or its excipients.
    b) Lactase deficiency, galactosemia or glucose-galactose malabsorption.
    c) History of GI bleeding or perforation due to previous Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) therapy or recurrent peptic ulcer/haemorrhage
    14. Active bleeding (excluding menses) or bleeding diathesis including patients on chronically high doses of NSAIDs
    15. Pregnant or lactating women
    16. Women of childbearing potential and fertile men who do not agree to use at least one primary form of contraception during the study and up to 30 days after the last IMP dose.
    1. Grave malattia epatica cronica (come verificato da anamnesi pertinente, immagini diagnostiche, se pre-esistenti, e punteggio Child-Pugh 12-15).
    2. Grave disfunzione renale cronica: eGFR (MDRD) <30 ml/min/1,73m2 o malattia renale allo stadio terminale in terapia renale sostitutiva.
    3. Partecipazione a un altro studio clinico interventistico.
    4. Pazienti per cui è stata clinicamente determinata un'elevata probabilità di morte entro le 24 ore successive in base alla stima dello SP.
    5. Evidenza di danno cerebrale anossico.
    6. Paziente attualmente sottoposto a ECMO o ventilazione oscillatoria ad alta frequenza.
    7. Estubazione prevista entro 24 ore dall'arruolamento.
    8. Neoplasia maligna attiva (ad eccezione dei tumori cutanei non melanoma).
    9. Instabilità emodinamica (>30% di aumento dei farmaci vasoattivi nelle ultime 6 ore o norepinefrina >0,5 mcg/kg/min).
    10. Evidenza di dismotilità gastrointestinale, ad esempio, a causa di pancreatite acuta o stato post-operatorio immediato, come dimostrato da distensione gastrica persistente, intollerabilità all'alimentazione enterale e/o residui gastrici persistenti >500 ml).
    11. Dimissione prevista dall'ospedale o trasferimento in altro ospedale entro 72 ore dallo screening.
    12. Decisione di sospendere o interrompere il trattamento di sostegno vitale (i pazienti possono comunque essere idonei se sottoposti a supporto completo, ad eccezione della rianimazione cardiopolmonare in caso di arresto cardiaco).
    13. Anamnesi di:
    a) Allergia documentata a più di un farmaco appartenente alla classe delle sulfonamidi, quali sulfametazina, sulfametoxazolo, sulfasalazina, nimesulide o celecoxib (l'ipersensibilità ai soli antibiotici sulfamidici, ad es. sulfametoxazolo, non è causa di esclusione), e al farmaco in studio e/o ai suoi eccipienti.
    b) Deficit di lattasi, galattosemia o malassorbimento di glucosio-galattosio.
    c) Anamnesi di sanguinamento o perforazione gastrointestinale dovuta a precedente terapia con FANS o ulcera/emorragia peptica ricorrente.
    14. Sanguinamento attivo (escluse le mestruazioni) o diatesi emorragica inclusi i pazienti in terapia cronica ad alte dosi con FANS.
    15. Pazienti di sesso femminile in gravidanza o allattamento.
    16. Donne in età fertile e uomini fertili che non accettano di utilizzare almeno una forma contraccettiva primaria durante lo studio e fino a 30 giorni dopo l'ultima dose di IMP.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    -Change in oxygenation index (OI) from baseline to day 7 of treatment. The OI is defined as: % mean airway pressure x FIO2/PaO2
    -Ventilator free days (VFD) at day 28
    End point primario:
    -Variazione dell'indice di ossigenazione (IO) dal basale al Giorno 7 di trattamento. L'IO è definito come: % della pressione media delle vie aeree x FIO2/PaO2
    -Giorni senza ventilazione (Ventilator Free Days, VFD) al Giorno 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline to day 7 of treatment
    at day 28
    dal basale al giorno 7 di trattamento
    al giorno 28
    E.5.2Secondary end point(s)
    -Change in OI from baseline to day 4 (±8h)
    -Acute lung injury score [composite of PaO2/FIO2 ratio, PEEP, lung compliance (plateau airway pressure minus PEEP/TV) and extent of pulmonary infiltrates] at 2(±8h), 3(±8h), 7±1, 14±2 days (if still intubated)
    -SOFA scores at 2(±8h), 3(±8h), 7±1, 14±2 days (if still intubated)
    -Ventilatory ratio (product of minute ventilation and PaCO2) at 2(±8h), 3(±8h), 7±1, 14±2 days (if still intubated)
    - Incidence of ECMO at day 14±2
    - Use of vasoactive medications at day 14±2
    - CXR assessment of pulmonary edema by “radiographic assessment of lung edema” (RALE) score at 2(±8h), 3(±8h), 7±1, 14±2 days
    - Percentage of patients achieving pressure support ventilation equal to 5 cm H20 with PEEP equal to 5 cm H20 for 2 hours (measure of weaning) by day 28±2 or hospital discharge
    - ICU-free days by day 28±2 or hospital discharge
    - Hospital-free days by day 28±2 or hospital discharge
    - Incidence of tracheostomies by day 28±2 or hospital discharge
    - Incidence of LTAC facility by day 28±2 or hospital discharge
    - All-cause mortality by day ±2or hospital discharge
    - All-cause mortality by day 60
    - Change from baseline to day 3±8h, 7±1 and 14±2 in plasma levels of Il-6, IL-8, PAI-1, Plasma TNFr-1, ICAM-1 RAGE
    - Variazione dell'IO dal basale al Giorno 4 (± 8h)
    - Punteggio di danno polmonare acuto (composito di rapporto PaO2/FIO2, PEEP, compliance polmonare [pressione di plateau delle vie aeree meno PEEP/TV] ed entità degli infiltrati polmonari) ai Giorni 2 (± 8h), 3 (± 8h), 7 ±1, 14 ±2 (se ancora intubato)
    - Punteggi SOFA ai Giorni 2 (± 8h), 3 (± 8h), 7 ±1, 14 ±2 giorni (se ancora intubato)
    - Rapporto ventilatorio (prodotto di ventilazione minuto e PaCO2) ai Giorni 2 (± 8h), 3 (± 8h), 7 ±1, 14 ±2 (se ancora intubato)
    - Incidenza di ECMO entro il Giorno 14 ±2
    - Uso di farmaci vasoattivi entro il Giorno 14 ±2
    - Valutazione RXT dell'edema polmonare mediante "valutazione radiografica dell'edema polmonare" (punteggio RALE) ai Giorni 2 (± 8h), 3 (± 8h), 7 ±1, 14 ±2
    - Percentuale di pazienti che ottengono una ventilazione di supporto della pressione pari a 5 cm H20 con PEEP pari a 5 cm H20 per 2 ore (misura dello svezzamento) entro il Giorno 28 ±2 o alla dimissione dall'ospedale
    - Giorni non in UTI entro il Giorno 28 ±2 o alla dimissione dall'ospedale
    - Giorni non in ospedale entro il Giorno 28 ±2 o alla dimissione dall'ospedale
    - Incidenza di tracheotomie entro il Giorno 28 ±2 o alla dimissione dall'ospedale
    - Incidenza del trasferimento alla LTAC entro il Giorno 28 ±2 o alla dimissione dall'ospedale
    - Mortalità per tutte le cause entro il Giorno 28 ±2 o alla dimissione dall'ospedale
    - Mortalità per tutte le cause entro il Giorno 60
    - Variazione dal valore basale al Giorno 3 (± 8h), 7 ±1 e al Giorno 14 ±2 dei livelli plasmatici di Il-6, IL-8, PAI-1, TNFr-1, ICAM-1, RAGE
    E.5.2.1Timepoint(s) of evaluation of this end point
    Per protocol
    Secondo il protocollo
    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 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 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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Germany
    Italy
    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
    Date of the last assessment of the last patient
    Data dell'ultima valutazione dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days11
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally authorized representative consent will be required for most subjects due to alteration in their level of consciousness caused by therapeutic sedation.
    Per la maggior parte dei soggetti sarà richiesto il consenso del rappresentante legalmente autorizzato a causa dell'alterazione del loro livello di coscienza causata dalla sedazione terapeutica.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 66
    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 completion of the 28-day assessment or at study termination (for any other reason), patients will receive post-study care as prescribed by their non-study health care provider. No post-study or post study-termination treatment will be provided by the study team or Dompé.
    Dopo il completamento della valutazione al giorno 28 o al termine dello studio (per qualsiasi altro motivo), i pazienti riceveranno assistenza post-studio come prescritto dal loro fornitore di assistenza sanitaria non dello studio. Nessun trattamento post-studio o post-conclusione del trattamento dello studio sarà fornito dal team di studio o da Dompé.
    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 Decision2022-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-12
    P. End of Trial
    P.End of Trial StatusOngoing
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