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    Summary
    EudraCT Number:2018-002448-10
    Sponsor's Protocol Code Number:BIA-51058-201
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-04
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2018-002448-10
    A.3Full title of the trial
    An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease.
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH
    A.4.1Sponsor's protocol code numberBIA-51058-201
    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.5.6E-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.3.9.3Other descriptive nameBIA 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 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
    Pulmonary arterial hypertension
    E.1.1.1Medical condition in easily understood language
    Pulmonary arterial hypertension
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064911
    E.1.2Term Pulmonary arterial hypertension
    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
    The primary objective of this study is to evaluate the PK profile of different zamicastat doses in PAH patients to find the most promising therapeutic dosage range for the treatment of PAH disease
    E.2.2Secondary objectives of the trial
    To assess further PK parameters, efficacy, safety and tolerability of different zamicastat doses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 18 to 65 years.
    2. Able to comprehend and willing to sign an informed consent form.
    3. Diagnosis of PAH (pulmonary arterial hypertension WHO Group 1), documented by right heart catheterisation with a mean pulmonary artery pressure (mPAP) ≥ 25 mmHg, a pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg and a pulmonary vascular resistance (PVR) > 3 WU [Galie N, et. al 2015; Lau EMT, et. al. 2017]:
    a) Idiopathic, in non-vasoreactive patients
    b) Heritable: Bone morphogenetic protein receptor type II (BMPR2) mutation and other mutations, in non-vasoreactive patients
    c) Drugs and toxin induced, in non-vasoreactive patients
    d) Associated with connective tissue disease or with simple congenital defects (atrial septal defect and/or ventricular septal defect) if closed > 12 months before inclusion.
    4. WHO functional class II or III as judged by the investigator.
    5. Stable treatment with at least one of the following approved PAH therapies for at least
    90 days prior to V1: Ambrisentan, Bosentan, Macitentan, Riociguat, Selexipag,
    Sildenafil, Tadalafil, Epoprostenol intravenous, Iloprost inhaled or Treprostinil
    intravenous or subcutaneous.
    E.4Principal exclusion criteria
    1. Contraindication to zamicastat, i.e. known hypersensitivity to ingredients of zamicastat formulation.
    2. Two or more consecutive measurements of SBP < 95 mmHg or DBP < 50 mmHg.
    3. Uncontrolled diabetes mellitus with HbA1c ≥ 8.5% within the last three months or at
    screening.
    4. PAH WHO Group 1 due to portal hypertension, human immunodeficiency virus (HIV) infection and schistosomiasis.
    5. Any disease known to cause pulmonary hypertension other than PAH WHO Group 1.
    6. Obstructive lung disease: Forced Expiratory Volume in 1 second/Forced Vital Capacity
    (FEV1/FVC) < 60% and FEV1 < 60% of predicted value after bronchodilator
    administration.
    7. Restrictive lung disease: Total Lung Capacity (TLC) < 70% of predicted value.
    8. History of moderate to severe hepatic impairment (Child-Pugh B and C).
    9. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (measured at V1).
    10. 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 DβH e.g. rimiterole, isoprenaline, dopamine, dopexamine or dobutamide) or α- and/or β-blockers.
    11. Current or previous (within the past year) alcohol or substance abuse excluding caffeine or nicotine.
    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 acceptable contraceptive measures
    from the time of informed consent until 30 days after last IMP intake. Acceptable
    methods for women are surgical intervention (e.g. bilateral tubal occlusion), nonhormonal
    implantable intrauterine device, double-barrier methods, 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 progestogen-only hormonal
    contraception (oral, injectable/implantable, intrauterine hormone-releasing system);
    partner’s use of implantable intrauterine device; surgical sterilisation (for example,
    vasectomy or bilateral tubal occlusion).
    14. Previous participation in any other drug investigational study within the past 30 days (or five half-lives of investigational medicinal product [IMP] whichever is longer) prior to V1.
    15. Vulnerable patients according to Section 1.61 of the ICH guideline for Good Clinical
    Practice E6.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate pharmacokinetic (PK) profile of different zamicastat doses in PAH patients to find the most promising therapeutic dosage range for the treatment of PAH disease
    E.5.1.1Timepoint(s) of evaluation of this end point
    Once the last PK sample of the last patient has been analysed.
    E.5.2Secondary end point(s)
    To assess further PK parameters, efficacy, safety and tolerability of different zamicastat doses
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once the last PK, efficacy, safety and tolerability parameters of the last patient has been analysed.
    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 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 No
    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 EEA15
    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
    Austria
    Belgium
    France
    Germany
    Italy
    Netherlands
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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)
    At the end of the maintenance period, the patient will have the opportunity to continue treatment in an extension study (BIA-51058-202), which will be described in a separate protocol.
    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 Decision2018-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-19
    P. End of Trial
    P.End of Trial StatusOngoing
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