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    Summary
    EudraCT Number:2014-002037-59
    Sponsor's Protocol Code Number:CSPH-EX-0414
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-11
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-002037-59
    A.3Full title of the trial
    Clinical Study of the BreathID® LF System to train the algorithm for the ¹³C-Methacetin Breath Test (MBT) in assessment of Portal Hypertension in Patients with Compensated Liver Cirrhosis
    Estudio clínico del sistema BreathID® LF para desarrollar el algoritmo para la prueba de aliento con ¹³C-metacetina en la evaluación de la hipertensión portal en pacientes con cirrosis hepática compensada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Study of the BreathID LF System to develop a diagnosis technique to Detect Severe Portal Hypertension in the Liver
    Estudio clínico del Sistema BreathID para desarrollar una técnica de diagnóstico para la detección de la hipertensión portal en el hígado.
    A.3.2Name or abbreviated title of the trial where available
    Protocol Number: CSPH-EX-0414
    N.º de protocolo: CSPH-EX-0414
    A.4.1Sponsor's protocol code numberCSPH-EX-0414
    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 SponsorExalenz BioScience Ltd.
    B.1.3.4CountryIsrael
    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 supportExalenz Bioscience Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clìnic de Barcelona
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932275400282
    B.5.6E-mailJCGARCIA@clinic.ub.es
    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 name¹³C-Methacetin
    D.3.4Pharmaceutical form Powder for oral solution
    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 INN13C-methacetin
    D.3.9.3Other descriptive nameN-(4)-methoxyphenyl acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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
    Compensated Liver Cirrhosis and indication to undergo HVPG testing
    Cirrosos hepática compensada y prescripción para someterse a la prueba GPVH
    E.1.1.1Medical condition in easily understood language
    Cirrhosis
    Cirrosis
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to develop an algorithm and its cut-off to detect CSPH, defined as HVPG ≥10mmHg, based on the MBT.
    El objetivo principal del estudio es desarrollar un algoritmo y su límite para detectar HPCS, definida como GPVH ≥ 10 mm Hg, en función de la prueba MBT.
    E.2.2Secondary objectives of the trial
    Binary diagnosis of portal hypertension with HVPG ≥ 12mmHg
    Binary diagnosis of portal hypertension with HVPG ≥ 20mmHg
    Correlation of MBT with HVPG readings
    Assess the effect of beta blockers on the Correlation of MBT with HVPG readings
    Examine the effect of a single small (<3cm) HCC (hepatocellular carcinoma) on the correlation of MBT with HVPG tracings
    Diagnóstico binario de hipertensión portal con GPVH ≥ 12 mm Hg
    Diagnóstico binario de hipertensión portal con GPVH ≥ 20 mm Hg
    Correlación de la prueba MBT con las lecturas de GPVH
    Evaluar el efecto de los betabloqueantes sobre la correlación de la prueba MBT con las lecturas de GPVH
    Examinar el efecto de un único carcinoma hepatocelular (CHC) pequeño (< 3 cm) sobre la correlación de la prueba MBT con los trazados de GPVH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult men or women (>18 years of age)
    2. Able (or legal guardian) and willing to sign an Informed Consent Form
    3. Known chronic liver disease with cirrhosis confirmed by either:
    a. liver biopsy or
    b. clinical (palpable left lobe, splenomegaly) and laboratory (platelets <150,000/mm3 or albumin< 3.8g/dL, or INR >1.3) evidence of cirrhosis and/or
    c. imaging studies by abdominal sonography, computer assisted axial tomography, or magnetic resonance imaging, showing a nodular liver and/or enlarged spleen and/or portosystemic collaterals with portal vein patency and/or minimal ascites, and/or colloid shift on a colloid-isotope liver-spleen scan or measurements of liver stiffness suggestive of cirrhosis

    4. Indicated to undergo HVPG testing
    5. Can tolerate an overnight (8-hour) fast
    6. For patients treated with beta blockers: They have to be on a stable dose for at least 6 weeks prior to any study related tasks (MBT or HVPG measurement)
    7. For patients who stopped their treatment with beta blockers: Their last dose should be at least 6 weeks prior to any study related tasks (MBT or HVPG measurement)
    1. Adultos varones o mujeres (> 18 años de edad)
    2. Paciente con capacidad y disposición para firmar un Formulario de consentimiento informado
    3. Hepatopatía crónica diagnosticada con cirrosis confirmada mediante:
    a. biopsia hepática o
    b. signos clínicos (lóbulo izquierdo palpable, esplenomegalia) y analíticos (trombocitos < 150 000/mm3 o albúmina < 3,8 g/dl, o INR > 1,3) de cirrosis y/o
    c. estudios de diagnóstico por imagen mediante ecografía abdominal, tomografía computerizada asistida o resonancia magnética, que muestran un hígado nodular y/o esplenomegalia y/o colaterales portosistémicas con permeabilidad de la vena porta y/o ascitis mínima, y/o dispersión coloidal en un escáner hepático-esplénico coloidal-isotópico o determinaciones de rigidez hepática indicativa de cirrosis.
    4. Europa: Se indica la realización de una evaluación del GPVH EE.UU.: Consentimiento para GPVH
    5. Paciente que pueda tolerar una noche de ayuno (8 horas)
    6. En pacientes bajo tratamiento con betabloqueantes: Deben haber tomado una dosis estable durante al menos 6 semanas antes de los procedimientos relaciorelacionados con el estudio (MBT o determinación del GPVH)
    7. En los pacientes que hayan dejado de tomar su tratamiento con betabloqueantes: Deben haber tomado su última dosis al menos 6 semanas antes de los procedimientos relacionados con el estudio (MBT o determinación del GPVH)
    E.4Principal exclusion criteria
    1. Decompensated cirrhosis as clinically defined by the occurrence of any of the following: ascites, hepatic encephalopathy, variceal bleeding or hepatorenal syndrome
    2. Renal failure (creatinine > 2.5 mg/dl)
    3. Known acute renal tubular disease
    4. Known hypotension (Systolic Pressure <100mmHg)
    5. Hypocoagulablity defined as PT >6 and INR >2.3.
    6. Congestive heart failure (assessed clinically as NIHA >2)
    7. Known pulmonary hypertension (right ventricular systolic pressure > 45 mm Hg)
    8. Uncontrolled diabetes mellitus (HBA1C >9.5gr%)
    9. Concurrent prednisone or immunosuppressive treatment, if therapy and/or response to treatment are not stable for at least 3 months.
    10. Documented hepatocellular carcinoma lesion larger than 3cm and/or multifocal lesions and/or evidence of vascular invasions
    11. Gastric bypass surgery or extensive small bowel resection
    12. Total parenteral nutrition
    13. Any organ transplant recipient
    14. Pregnant or breast feeding
    15. Allergy to acetaminophen and/or other related medications.
    16. Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen)
    17. Uncontrolled malabsorption or diarrhea
    18. Documented non-cirrhotic PHT, partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a transjugular intrahepatic portosystemic shunt (TIPS)
    19. Primary or secondary biliary cirrhosis, primary or secondary sclerosing cholangitis, hepatic sarcoidosis, or other cholestatic disorders
    20. Subjects unable to perform the MBT within 7 days of HVPG procedure.
    21. Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir , allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
    22. Subject should not have taken amiodarone or statins within the last 30 days prior to the breath test or HVPG procedure
    1. Pacientes con cirrosis descompensada, definida clínicamente por la aparición de cualquiera de los siguientes trastornos: ascitis, encefalopatía hepática, hemorragia por varices o síndrome hepatorrenal
    2. Insuficiencia renal (creatinina > 2,5 mg/dl)
    3. Diagnóstico de enfermedad tubular renal aguda
    4. Diagnóstico de hipotensión (presión sistólica < 100 mm Hg)
    5. Hipocoagulabilidad, definida como TP > 6 e INR > 2,3.
    6. Insuficiencia cardíaca congestiva (evaluada clínicamente como NYHA > 2)
    7. Diagnóstico de hipertensión pulmonar (presión sistólica ventricular derecha > 45 mm Hg)
    8. Diabetes mellitus no controlada (HBA1C > 9,5 gr%)
    9. Tratamiento concomitante inmunosupresor o con prednisona, si el tratamiento y/o la respuesta al tratamiento no son estables durante al menos 3 meses.
    10. Lesión de carcinoma hepatocelular documentada de más de 3 cm y/o lesiones multifocales y/o signos de invasiones vasculares
    11. Intervención quirúrgica de derivación gástrica o resección extensa de intestino delgado
    12. Nutrición parenteral total
    13. Receptor de un trasplante de cualquier órgano
    14. Embarazo o lactancia
    15. Alergia a acetaminofeno y/o otros medicamentos relacionados.
    16. Diagnóstico de hepatotoxicidad concurrente relacionada con el fármaco o esteatosis asintomática relacionada con el fármaco o fibrosis relacionada con el fármaco (p. ej., amiodarona, metotrexato y tamoxifeno)
    17. Diarrea o malabsorción no controlada
    18. Diagnóstico de HTP no cirrótica, oclusión venosa portal parcial/completa, oclusión venosa hepática, intervención quirúrgicaprevia para HTP o colocación de una derivación portosistémica intrahepática transyugular (DPIT)
    19. Cirrosis biliar primaria o secundaria, colangitis esclerosante primaria o secundaria, sarcoidosis hepática u otros trastornos colestásicos
    20. Pacientes incapaces de realizar la prueba MBT en los 7 días previos al procedimiento de GPVH.
    21. El paciente no debe haber tomado ninguna de las siguientes medicaciones durante al menos 48 horas antes de la prueba de aliento: aciclovir, alopurinol, carbamazepina, cimetidina, ciprofloxacino, daidzeína, disulfiram (a base de plantas), equinácea, enoxacino, famotidina, fluvoxamina, metoxsaleno, mexiletina, montelukast, norfloxacino, fenilpropanolamina, fenitoína, propafenona, rifampicina, terbinafina, ticlopidina, tiabendazol, verapamilo, zileutón o anticonceptivos orales o cualquier medicamento que pueda interferir en el metabolismo de metacetina o pueda afectar a CYP 1A2
    22. El paciente no debe haber tomado amiodarona o estatinas en los últimos 30 días antes de la prueba de aliento o del procedimiento de GPVH
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to develop an algorithm and its cut-off to detect CSPH, defined as HVPG ≥10mmHg, based on the MBT.
    Binary diagnosis of CSPH, defined as HVPG ≥10 mmHg, correlated with an MBT result to be developed.
    El objetivo principal del estudio es desarrollar un algoritmo y su límite para detectar HPCS, definida como GPVH ≥ 10 mm Hg, en función de la prueba MBT.
    Diagnóstico binario de HPCS, definida como GPVH ≥ 10 mm Hg, correlacionado con un resultado de la prueba MBT que se va a desarrollar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.5.2Secondary end point(s)
    Binary diagnosis of portal hypertension with HVPG ≥ 12mmHg
    Binary diagnosis of portal hypertension with HVPG ≥ 20mmHg
    Correlation of MBT with HVPG readings
    Assess the effect of beta blockers on the Correlation of MBT with HVPG readings
    Examine the effect of a single small (<3cm) HCC (hepatocellular carcinoma) on the correlation of MBT with HVPG tracings
    Diagnóstico binario de hipertensión portal con GPVH ≥ 12 mm Hg
    Diagnóstico binario de hipertensión portal con GPVH ≥ 20 mm Hg
    Correlación de la prueba MBT con las lecturas de GPVH
    Evaluar el efecto de los betabloqueantes sobre la correlación de la prueba MBT con las lecturas de GPVH
    Examinar el efecto de un único carcinoma hepatocelular (CHC) pequeño (< 3 cm) sobre la correlación de la prueba MBT con los trazados de GPVH
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 months
    18 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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
    GPVH - Gradiente de presión venosa hepática
    HVPG (Hepatic Vein Portal Pressure Gradient) procedure
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    A written report is required for all patients who die within 30 days after the end of their participation in the study. LVLS+30 days
    Se requiere un informe escrito de todos aquellos pacientes que fallezcan 30 días después del final de su participación en el estudio LVLS+ 30 días
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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
    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 Decision2015-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-11
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