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    Summary
    EudraCT Number:2018-002796-18
    Sponsor's Protocol Code Number:BIA-51058-202
    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:2021-01-29
    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 number2018-002796-18
    A.3Full title of the trial
    An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease
    Studio multicentrico in aperto per valutare la sicurezza e l’efficacia di zamicastat come terapia aggiuntiva nel trattamento a lungo termine dell’ipertensione arteriosa polmonare (IAP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH.
    Studiare la sicurezza e l'efficacia della massima dose tollerata di zamicastat, individuata nel BIA-51058-201, nel trattamento a lungo termine dell'IAP.
    A.3.2Name or abbreviated title of the trial where available
    Safety and efficacy of BIA 5-1058 in PAH
    Sicurezza ed efficacia di BIA 5-1058 nella IAP
    A.4.1Sponsor's protocol code numberBIA-51058-202
    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 SponsorBIAL-Portela & Ca, S.A.
    B.1.3.4CountryPortugal
    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 supportBial - Portela & Ca, S.A.
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBial - Portela & Ca, S.A.
    B.5.2Functional name of contact pointDevelopment Department
    B.5.3 Address:
    B.5.3.1Street AddressÀ Av. da Siderurgia Nacional
    B.5.3.2Town/ cityCoronado (S. Romão e S. Mamede)
    B.5.3.3Post code4745-457
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351229866100
    B.5.5Fax number+351229866192
    B.5.6E-mailana.santos@bial.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 namezamicastat
    D.3.2Product code [BIA-5-1058]
    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 INNzamicastat
    D.3.9.1CAS number 1080028-80-3
    D.3.9.2Current sponsor codeBIA 5-1058
    D.3.9.4EV Substance CodeSUB192395
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary arterial hypertension
    Ipertensione arteriosa polmonare
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension
    Ipertensione arteriosa polmonare
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.2Term Respiratory, thoracic and mediastinal disorders
    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 assess the safety and tolerability of the individual highest tolerated zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in PAH disease.
    Valutare la sicurezza e la tollerabilità delle dosi più elevate tollerate individuali di zamicastat, raggiunte nello studio BIA-51058-201, durante il trattamento a lungo termine dell'IAP.
    E.2.2Secondary objectives of the trial
    To assess further efficacy, safety and tolerability parameters of the individual highest tolerated zamicastat doses in long-term treatment of PAH.
    Valutare ulteriori parametri di efficacia, sicurezza e tollerabilità delle dosi più elevate tollerate individuali di zamicastat nel trattamento a lungo termine dell'IAP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have performed MPV3 of the preceding study BIA-51058-201.
    2. Able to comprehend and willing to sign an informed consent form.
    3. For women: Agree not to donate ova from the time of informed consent until 30 days after the last IMP intake.
    For men: Agree not to donate sperm from the time of informed consent until 90 days after the last IMP intake.
    1. Avere effettuato la visita MPV3 dello studio BIA-51058-201 precedente.
    2. Essere in grado di comprendere e disposti a firmare un modulo di consenso informato.
    3. Per le donne: essere d’accordo a non donare ovuli dal momento del consenso informato fino a 30 giorni dopo l’ultima
    assunzione dell’ IMP.
    Per gli uomini: essere d’accordo a non donare sperma dal momento del consenso informato fino a 90 giorni dopo
    l’ultima assunzione dell’ IMP.
    E.4Principal exclusion criteria
    1. Significant non-compliance with the protocol during the preceding study BIA-51058-201 which may have an impact on this extension study. 2. WHO functional class IV as judged by the investigator. 3. Two or more consecutive measurements of systolic blood pressure (SBP) < 95 mmHg or diastolic blood pressure (DBP) < 50 mmHg, measured at visit V1. 4. Uncontrolled diabetes mellitus with HbA1c = 8.5% within the last three months or at visit V1. 5. Occurrence of an AE during the preceding study which is judged by the investigator as contraindicative to further participation in the extension study. 6. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1. 7. Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) < 60% and FEV1 < 60% of predicted value after bronchodilator administration, as demonstrated and documented by previous spirometry data which, in the opinion of the investigator, represent the clinical state of the patient at the time of visit V1. 8. Restrictive lung disease: Total Lung Capacity (TLC) < 70% of predicted value, as demonstrated and documented by previous spirometry data which, in the opinion of the investigator, represent the clinical state of the patient at the time of visit V1. 9. History of moderate to severe hepatic impairment (Child-Pugh B and C). 10. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at MPV1 of study BIA-51058-201). 11. Use of the following prohibited medication or treatments during study participation: calcium channel blockers (CCBs) if used for the treatment of PAH in vasoreactive patients; drugs containing a catechol group that is metabolised by DßH (e.g. rimiterole, isoprenaline, dopamine, dopexamine or dobutamide) or a- and/or ß-blockers. 12. Presence of any other significant or progressive/unstable medical condition that, in the opinion of the investigator, would compromise evaluation of the study treatment or may jeopardise the patient’s safety, compliance or adherence to protocol requirements. 13. For women: Pregnancy or breast-feeding. Women of childbearing potential unable or unwilling to undergo pregnancy tests and practice highly effective contraceptive measures in combination with a barrier method e.g. condom, occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository from the time of informed consent until 30 days after the last IMP intake. Highly effective methods for women are surgical intervention (e.g. bilateral tubal occlusion), non-hormonal implantable intrauterine device, true sexual abstinence (i.e. when this is in line with the preferred and usual lifestyle of the patient) and vasectomised partner (provided that the partner is the sole sexual partner of the patient and the partner has received medical assessment of the surgical success). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), hormonal contraceptives and withdrawal are not acceptable methods of contraception. For men: Male patients who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved acceptable contraceptive measure from the time of informed consent until 90 days after the last IMP intake. The following methods are acceptable methods of contraception: partner’s use of combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); partner’s use of progestogenonly hormonal contraception (oral, injectable/implantable, intrauterine hormonereleasing system); partner’s use of implantable intrauterine device; surgical sterilisation (for example, vasectomy or bilateral tubal occlusion). 14. Concurrent participation in any other drug investigational study, except BIA-51058-201. 15. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical Practice E6.
    1. Importante non conformità con il protocollo durante lo studio BIA-51058-201 precedente che potrebbe avere un impatto su questo studio di estensione. 2. Classe funzionale IV dell'OMS, a giudizio dello sperimentatore. 3. Due o più misurazioni consecutive della pressione arteriosa sistolica (SBP) < 95 mmHg o pressione arteriosa diastolica (DBP) < 50 mmHg, misurate alla V1
    4. Diabete mellito non controllato con HbA1c = 8.5% negli ultimi tre mesi o alla visita V1. 5. Comparsa di un evento avverso (AE) durante lo studio precedente giudicato dallo sperimentatore come controindicazione alla partecipazione allo studio di estensione. 6. Qualsiasi patologia nota per causare ipertensione polmonare diversa da IAP Gruppo 1 dell’OMS. 7. Malattia polmonare ostruttiva: Volume Espiratorio Massimo ad 1 secondo/Capacità Vitale Forzata (FEV1/FVC) < 60% e FEV1 < 60% del valore predetto in seguito a somministrazione di un broncodilatatore, come dimostrato e documentato da precedenti dati spirometrici che, secondo il giudizio dello sperimentatore, rappresentano lo stato clinico del paziente al momento della visita V1. 8. Malattia polmonare restrittiva: Capacità Polmonare Totale (TLC) < 70% del valore predetto, come dimostrato e documentato da precedenti dati spirometrici che, secondo il giudizio dello sperimentatore, rappresentano lo stato clinico del paziente al momento della visita V1. 9. Anamnesi positiva per compromissione epatica da moderata a grave (Child-Pugh B e C).
    10. Velocità di filtrazione glomerulare stimata (eGFR) < 30 ml/min/1,73 m2 (misurata alla MPV1 dello studio BIA-51058-201). 11. Uso dei seguenti farmaci o trattamenti vietati durante la partecipazione allo studio: bloccanti dei canali del calcio (CCB) se impiegati per il trattamento dell’IAP in pazienti vasoreattivi; farmaci contenenti un gruppo catecolico metabolizzato da DßH (ad es. rimiterolo, isoprenalina, dopamina, dopexamina o dobutamide) o a- e/o ß-bloccanti. 12. Presenza di qualsiasi altra condizione clinica significativa o progressiva/instabile che, a parere dello sperimentatore, comprometterebbe la valutazione del trattamento sperimentale o potrebbe mettere a rischio la sicurezza del paziente, la conformità o l'aderenza ai requisiti del protocollo.
    13. Per le donne: Gravidanza o allattamento. Donne potenzialmente fertili non in grado o non disposte a sottoporsi ai test di gravidanza e ad adottare misure contraccettive altamente efficaci in combinazione con un metodo di barriera ad es.preservativo, cappuccio occlusivo (diaframma o cappucci cervicali) con gel/film/crema/supposta spermicida dal momento del consenso informato fino a 30 giorni dopo l’ultima somministrazione dell’IMP. Metodi altamente efficaci per le donne sono intervento chirurgico (ad es. occlusione tubarica bilaterale), dispositivo intrauterino impiantabile non ormonale, reale astinenza sessuale (se ciò è in linea con lo stile di vita preferito e abituale della paziente) e partner vasectomizzato (a condizione che il partner sia l'unico partner sessuale del paziente e che il partner abbia ricevuto una valutazione medica del successo chirurgico). L'astinenza periodica (ad es. metodi del calendario, dell'ovulazione, sintotermico, post-ovulazione), contraccettivi ormonalie il coito interrotto non sono metodi di contraccezione accettabili. 14. Partecipazione concomitante a qualsiasi altra sperimentazione farmacologica, eccetto lo studio BIA-51058-201. 15. Pazienti vulnerabili, secondo la sezione 1.61 delle linee guida ICH di buona pratica clinica E6.
    E.5 End points
    E.5.1Primary end point(s)
    The safety and tolerability of the used zamicastat doses will be evaluated by:
    1. Adverse events
    2. Clinically relevant changes in laboratory parameters (haematology, biochemistry,
    coagulation, urinalysis, arterial blood gas analysis)
    3. Clinically relevant changes in vital signs
    4. Clinically relevant changes in ECG parameters
    5. Number of digital scars (only in patients with scleroderma)
    6. Skin score (only in patients with scleroderma)
    La sicurezza e la tollerabilità delle dosi di zamicastat utilizzate saranno valutate in base a:
    1. Eventi avversi
    2. Variazioni clinicamente rilevanti dei parametri di laboratorio (ematologici, biochimici, coagulazione, analisi delle urine, emogasanalisi)
    3. Variazioni clinicamente rilevanti dei parametri vitali
    4. Variazioni clinicamente rilevanti dei parametri dell’ECG
    5. Numero di cicatrici digitali (solo in pazienti affetti da sclerodermia)
    6. Punteggio cutaneo (solo in pazienti affetti da sclerodermia)
    E.5.1.1Timepoint(s) of evaluation of this end point
    As soon as the last subject has completed the last visit and all data have been locked, the results will be analysed and described in a Clinical Study Report.
    Non appena l'ultimo soggetto avrà completato l'ultima visita e tutti i dati saranno stati bloccati, i risultati verranno analizzati e descritti nel Clinical Study Report.
    E.5.2Secondary end point(s)
    Change from baseline* to V5 (if applicable) and from V1 to V5 (if applicable) for the following parameters:
    1. Pulmonary vascular resistance (PVR), right atrial pressure (RAP), mean pulmonary artery pressure (mPAP), cardiac index (CI) and mixed venous oxygen saturation (SvO2). Further haemodynamic parameters may also be calculated if considered appropriate.
    Change from baseline* to V3 and to V5/EDV and from V1 to V5/EDV for the following parameters:
    2. WHO functional class
    3. 6-minute walk test (6-MWT), including Borg dyspnoea score
    4. Biomarker (N-terminal pro brain natriuretic peptide [NT-proBNP])
    5. Echocardiogram parameters:
    • Tricuspid regurgitation, classified as absent, mild, moderate or severe
    • Right ventricular contractility, measured via tricuspid annular plane systolic
    excursion (TAPSE)
    • Pericardial effusion, classified as absent, traces or present
    • Right atrial area (end-systolic), right ventricular end-diastolic area
    6. Quality of life (SF-36v2)
    Variazioni dal basale* alla visita V5 (se applicabile) e dalla visita V1 alla visita V5 (se applicabile) per i seguenti parametri:
    1. Resistenza vascolare polmonare (PVR), pressione atriale destra (RAP), pressione arteriosa polmonare media (PAPm), indice cardiaco (IC) e saturazione di ossigeno venosa mista (SvO2). Se ritenuto opportuno, è inoltre possibile calcolare ulteriori parametri emodinamici.
    Variazioni dal basale* alla visita V3 e alla visita V5/EDV e dalla visita V1 alla visita V5/EDV per i seguenti parametri:
    2. Classe funzionale dell’OMS
    3. Test del cammino dei 6 minuti (6-MWT), compreso il punteggio della dispnea secondo Borg
    4. Biomaracatore (N-terminale del propeptide natriuretico cerebrale [NT-proBNP])
    5. Parametri ecocardiografici:
    • Rigurgito tricuspidale, classificato come assente, lieve, moderato o severo
    • Contrattilità ventricolare destra, misurata mediante escursione sistolica dell'anello tricuspidale (TAPSE)
    • Versamento pericardico, classificato come assente, in tracce o presente
    • Area atriale destra (telesistolica), area ventricolare destra telediastolica
    6. Qualità della vita (SF-36v2)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As soon as the last subject has completed the last visit and all data have been locked, the results will be analysed and described in a Clinical Study Report.
    Non appena l'ultimo soggetto avrà completato l'ultima visita e tutti i dati saranno stati bloccati, i risultati verranno analizzati e descritti nel Clinical Study Report.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Austria
    Germany
    Italy
    Portugal
    Spain
    Ukraine
    United Kingdom
    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
    Ultima visita dell'ultimo soggetto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 40
    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)
    Patients will have the opportunity to continue treatment with zamicastat in a compassionate use program.
    I pazienti avranno l'opportunità di continuare il trattamento con zamicastat in un programma di uso compassionevole.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-07
    P. End of Trial
    P.End of Trial StatusOngoing
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