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    Summary
    EudraCT Number:2015-005607-92
    Sponsor's Protocol Code Number:QUID-HF_V4.1_CZ_20170713
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-03-10
    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 number2015-005607-92
    A.3Full title of the trial
    A Phase II randomized, placebo controlled, double-blind, multi-centre study to assess safety and efficacy of incremental doses of QGC001 in patients upon discharge or following hospitalization for worsening chronic heart failure with left ventricular systolic dysfunction
    Short title: QUantum genomics Incremental Dosing in Heart Failure
    Acronym “ QUID-HF”
    Randomizovaná, placebem kontrolovaná, dvojitě zaslepená, multicentrická studie fáze II mající za cíl vyhodnocení bezpečnosti a účinnosti pravidelně zvyšovaných dávek QGC001 u pacientů po propuštění z nemocniční léčby nebo po hospitalizaci pro zhoršení stavu po chronickém srdečním selhání ze systolické dysfunkce levé komory
    Zkrácený název: QUantum genomics Incremental Dosing in Heart Failure zkratka „QUID-HF“
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An European study to assass safety and efficacy of a new drug in patients with worsening chronic heart failure.
    A.3.2Name or abbreviated title of the trial where available
    QUantum genomics Incremental Dosing in Heart Failure - QUID-HF
    A.4.1Sponsor's protocol code numberQUID-HF_V4.1_CZ_20170713
    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 SponsorQuantum Genomics
    B.1.3.4CountryFrance
    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 supportQuantum Genomics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEDDH - Fondation Force
    B.5.2Functional name of contact pointStéphanie Grojean
    B.5.3 Address:
    B.5.3.1Street AddressCentre de Medecine Preventive, 2 rue du doyen Jacques Parisot
    B.5.3.2Town/ cityVandoeuvre les Nancy
    B.5.3.3Post code54500
    B.5.3.4CountryFrance
    B.5.4Telephone number0033383501921
    B.5.5Fax number0033383501929
    B.5.6E-mailsgrojean@eddh.fr
    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 nameAmino butane sulfonate Disulfure
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule
    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 INNQCG001
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.3Other descriptive nameQGC001
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 nameAmino butane sulfonate Disulfure
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule
    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 INNQGC001
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.3Other descriptive nameQGC001
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Patient with worsening chronic heart failure with left ventricular systolic dysfunction
    E.1.1.1Medical condition in easily understood language
    Patient with worsening chronic heart failure
    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 LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.2System Organ Class 100000011680
    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 investigate the efficacy (rate of decrease in N terminal pro-hormone B-type natriuretic peptide (NT-proBNP) of more than 30% from baseline to Day 28) and the safety (blood pressure changes until Day 28) of QGC001 up-titrated from 50 mg twice daily to a maximum of 500 mg twice daily.
    E.2.2Secondary objectives of the trial
    Further exploratory objectives of the study are
    *To assess the effects of these doses on a composite endpoint of death from any cause and hospitalization for worsening heart failure (WHF) at Day 28 and after drug discontinuation up to Day 35.
    *To assess the effects of the respective dose levels, and of all doses combined, on changes in NT-proBNP and BNP, from baseline to Day 7, Day 14, Day 21, Day 28, and after drug discontinuation from day 28 to day 35
    *To assess the changes in quality of life Minnesota Living with Heart Failure questionnaire score from randomization to day 28
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *A signed and dated informed consent form prior to any study procedure
    *Adult male subjects and female subjects without childbearing potential.
    *Clinical diagnosis of CHF with history of NYHA class II-III for at least 3 months before randomisation.
    * Clinical diagnosis of WHF, as defined by a history of hospitalization for worsening symptoms of HF within the previous year. HF hospitalization is defined as an overnight stay in a hospital. Eligible subjects may be enrolled at any time before discharge from an episode of decompensated HF or during a post-discharge ambulatory state within one year of admission for WHF, if they fulfil all inclusion/exclusion criteria.
    *Documented left ventricular ejection fraction (LVEF)  40% measured by any modality within the previous 12 months in the subject’s medical history.
    *Subjects must also have at least one local measurement of BNP level ≥ 300 pg/mL or NT-proBNP level ≥1200 pg/mL (preferred assay, local laboratory) at the screening visit (maximum 7 days before randomisation).
    *eGFR > 45 mL/min/1.73 m2 (MDRD) at screening.
    *Serum potassium  5.0 mmol/L at screening.
    *Systolic blood pressure 110 mmHg (average of 3 consecutive measurements) at screening.
    *Prescribed to optimal pharmacologic therapy per “ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012”, or based on the updated current clinical practice, unless contra-indicated or not-tolerated, and on a stable dose for at least 30 days prior to enrolment (the dosage of the drugs cannot be increased or decreased respectively by more than double or half of initial dosage).
    *Taking oral loop diuretics at doses < 250 mg furosemide daily (or equivalent).
    E.4Principal exclusion criteria
    *BMI > 35 kg.m-2 .
    *Patients who require the use of HF IV therapy or oral furosemide > 250 mg (or equivalent) at any time during the 48 hours immediately before randomisation.
    *Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrolment.
    *Patients whose primary cause of heart failure is mitral or aortic valve disease or congenital heart disease or hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) or myocarditis.
    * Patients with “new” permanent atrial fibrillation (AF), discovered within 3 months prior to randomization.
    * Heart rate > 90 beats/min at screening.
    *Patients scheduled for Pacemaker (including ICD, CRT), Angioplasty, CABG or LVAD within the next 3 months.
    *Patients with documented chronic obstructive lung disease, defined as chronic need for oxygen therapy and/or daily-inhaled corticosteroid and/or daily bronchodilator treatment.
    *eGFR < 45 mL/min/1.73 m2 (MDRD) at screening.
    * Decrease in eGFR greater than 20% within 3 weeks prior to the screening visit..
    *Serum potassium > 5.0 mmol/L at screening.
    *Systolic blood pressure < 110 mmHg or with signs or symptoms of hypotension.
    *Symptomatic hypotension or orthostatic hypotension defined by a decrease of systolic blood pressure of more than 30 mm Hg in the standing vs. sitting position at screening and at T0 of the D0 (before having taken the study medication).
    * A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstrated of a QTc interval > 450 ms).
    * A history of additional risk factors for Torsade de Pointes (TdP) (e.g. hypokalemia, family history of long QT Syndrome).
    *The use of concomitant medications that prolong the QT/QTc interval.
    *Insulin-requiring diabetic patients (including type 1 Diabetes).
    *HbA1c ≥ 9% at screening visit.
    *History of angioneurotic edema.
    *Severe liver failure at screening defined by a value of ALAT and/or ASAT≥ 5 from the normal value.
    *Patients involved in any clinical study.
    *Patients who take an investigational or non-approved treatment.
    *Women of childbearing potential.
    *Patients with a prior cardiac transplant or patients currently on the list for cardiac transplantation.
    * Patient with hypersensitivity to the active substance or to one of the other components of the trial preparation.
    * Patients in whom an allergy requiring treatment is known or exists.
    *Patients with a history of previous illnesses of neurological or psychiatric nature that affect the Central Nervous System.
    *Patients with a life expectancy of less than 12 months per physician judgment.
    *Frail patient who, in the opinion of the investigator will not be able to follow the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    *The Efficacy Primary endpoint will be the percentage of subjects with a relative decrease in NT proBNP (Central Lab) of more than 30% from baseline to Day 28.
    *The Safety Primary endpoint will be the blood pressure changes at each visit, compared to the baseline measure
    E.5.1.1Timepoint(s) of evaluation of this end point
    for efficacy endpoint: at day 28 compared to Baseline
    for safety endpoint: at each visit, compared to the baseline
    E.5.2Secondary end point(s)
    *Blood biochemistry, electrolytes, urinary osmolarity at Day 7, Day 14, Day 21, Day 28, Day 35
    *Change in central lab values of NT-proBNP and BNP, at Day 7, Day 14, Day 21, Day 28, Day 35
    *Death from any cause or readmission for worsening heart failure at Day 28 and Day 35
    *Quality of life Minnesota Living with Heart Failure Score and D0 and Day 28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each visit compared to the baseline
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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 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 months5
    E.8.9.1In the Member State concerned days35
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days35
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 75
    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 completing the reandomized trial should stop the investigationnal drug and will follow the current standard treatment for heart failure
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-12
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