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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001818-42
    Sponsor's Protocol Code Number:C41750/3100
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-11-27
    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 ConcernedLatvia - SAM
    A.2EudraCT number2012-001818-42
    A.3Full title of the trial
    A Double-blind, Randomized, Sham–procedure–controlled, Parallel-group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (rexlemestrocel-L) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology: DREAM HF-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of allogeneic mesenchymal precursor cells (MPCs) in the treatment of heart failure.
    A.3.2Name or abbreviated title of the trial where available
    DREAM HF-1
    A.4.1Sponsor's protocol code numberC41750/3100
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02032004
    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 SponsorTeva Branded Pharmaceutical Products R&D, Inc.
    B.1.3.4CountryUnited States
    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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationinVentiv Health Clinical UK Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressThames House, 17-19 Marlow Road,
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 7AA
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441628408 401
    B.5.6E-mailRegopseurope@inventivhealth.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 nameRexlemestrocel-L (CEP-41750)
    D.3.2Product code CEP-41750
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracardiac use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRexlemestrocel-L
    D.3.9.2Current sponsor codeHuman bone marrow-derived allogeneic mesenchymal precursor cells (MPCs)
    D.3.9.3Other descriptive nameHuman bone marrow-derived allogeneic mesenchymal precursor cells (MPCs)
    D.3.9.4EV Substance CodeSUB69164
    D.3.10 Strength
    D.3.10.1Concentration unit million organisms million organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberTissue Engineered Product; reference number: EMA/CAT/512253/2010
    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
    Chronic Heart Failure
    E.1.1.1Medical condition in easily understood language
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    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 objectives of this study are to:
    •determine whether transendocardial delivery of 150 M allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) when administered during a single index cardiac catheterization and intracardiac mapping procedure is more effective than a scripted sham cardiac mapping and cell delivery procedure in risk reduction for recurrent (multiple events per patient) non-fatal decompensate HF events in the presence of terminal HF-related major adverse cardiac events (HF-MACE) in patients with chronic HF due to LV systolic dysfunction who have received optimal medical/ revascularization therapy. HF-MACE is defined as a composite of the following:
    For full list of primary objectives refer to section 2.2 of Protocol
    E.2.2Secondary objectives of the trial
    •total hospital admissions for non-fatal decompensated HF events after index cardiac catheterization (with or without intracardiac mapping and cell delivery)
    •total hospital admissions or urgent HF visits for non-fatal decompensated HF events after index cardiac catheterization (with or without intracardiac mapping and cell delivery)
    •length of in-hospital stay in intensive care unit for decompensated HF
    •cardiac survival (captures only cardiac deaths)
    •overall survival (captures all cause deaths)
    •rate of recurrent non-fatal decompensated HF events resulting in hospitalization or urgent HF visits
    •time-to-first HF-MACE, defined as a composite of terminal HF-MACE (cardiac death, resuscitated cardiac death [including successful firing of an ICD for VF in patients who have an ICD or any implanted device capable of defibrillation], LVAD placement, heart transplant, artificial heart implantation) or non-fatal decompensated HF event.
    Please see section 2.2 of Protocol.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional exploratory PGx substudy:
    Blood samples will be collected from patients who provide informed consent for possible use in future PGx analyses for the assessment of possible associations between genetic polymorphisms and the response to rexlemestrocel-L therapy in patients with chronic HF.

    Holter monitor substudy:
    A 24 hour Holter monitor will be used to assess ventricular arrhythmias in patients enrolled at US and EU sites.
    E.3Principal inclusion criteria
    1. The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
    2. The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months before the initiation of screening procedures, with NYHA Functional Class II or Functional Class III symptoms. Chronic HF of ischemic etiology includes epicardial CAD defined as documented stenosis of at least 50% in one or more major epicardial coronary arteries or documented prior MI.
    3. The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), ACE inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month prior to study intervention (ie, hospitalization on day 0 for index cardiac catheterization with or without intracardiac mapping and cell
    delivery).
    4. The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during the screening period (flexible diuretic dosing that allows the patient to titrate the dose or add a dose of a second diuretic during screening is permitted, provided that the dosing regimen is not further altered and the patient remains stable during this period) or the patient is not on a regular dose of diuretics but takes diuretics as needed based on daily weight or the appearance of symptoms.
    5. The patient is not a candidate for either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as determined by the principal investigator (or designee) during screening.
    6. The patient may be on the cardiac transplant list. However, he/she must have low priority status with low probability of having a transplant procedure performed over the next 12 months (ie, cannot be UNOS status 1A or 1B).
    7. The patient has a LVEF of 40% or less as measured by 2-D echocardiogram, or 35% or less as measured by RVG within 42 days prior to study intervention (ie, hospitalization on day 0 for index cardiac catheterization with or without intracardiac mapping and cell delivery).
    8. The patient has 1 or more of the following:
    •at least 1 HF hospitalization more than 1 month, but 9 months or less before initiation of screening procedures
    •at least 1 outpatient visit requiring IV diuretic, vasodilator, and/or positive inotropic therapy more than 1 month, but 9 months or less before initiation of screening procedures
    •plasma levels of NT-pro-BNP greater than 1000 pg/mL (1000 ng/L SI units; 118 pmol/L) or 1200 pg/mL (1200 ng/L SI units; 141.6 pmol/L) for patients with atrial fibrillation
    9. If the patient has an ICD (or any implanted device capable of defibrillation) in place, the procedure must have occurred at least 1 month before initiation of screening procedures.
    10. If the patient has had CRT, the procedure must have occurred at least 3 months before screening.
    11. The patient has an LV diastolic wall thickness of at least 8 mm at the potential target site for cell injection.
    12. Women must be surgically sterile, 1 year post-menopausal, or must have a negative urine pregnancy test at screening.
    13.Women must be surgically sterile, 1 year post-menopausal, or, if of childbearing potential, currently using a medically accepted method of contraception, and must agree to continue to use this method of contraception after initiation of screening procedures and for 6 months after study intervention (ie, hospitalization on day 0 for
    index cardiac catheterization with or without intracardiac mapping and cell delivery).
    Acceptable methods of contraception refer Protocol
    14. The patient must be willing to return for required follow-up visits.
    15. Written informed consent is obtained for the study before any study-specific procedures are performed. A separate written informed consent for the exploratory PGx substudy is obtained before any PGx-specific procedures are performed. Participation in the PGx substudy is optional and consent may be collected at a later stage than screening (though preferred as early as possible). A patient will not be
    excluded from participation in the study if he/she chooses not to provide consent for the additional procedures that are required as part of the exploratory PGx substudy.
    16. Prior to the initiation of any procedures on day 0, the cell injection center will ensure that an institution-specific informed consent document is obtained, if applicable
    E.4Principal exclusion criteria
    Subjects will not be enrolled into this study if they meet ANY of the following criteria:
    1.The patient has NYHA Functional Class I or Functional Class IV symptoms.
    2.The patient has had an acute MI within 1 month before initiation of the screening procedures.
    3.The patient has unstable angina pectoris within 1 month before initiation of screening procedures; unstable angina is defined as the occurrence of chest pain more frequently than usual, pain at rest or upon minimal exertion, or protracted episodes of pain without any discernible trigger, and/or chest pain that persists despite use of vasodilatory therapy (eg, nitroglycerin) and or aggravation of stable angina or new onset angina.
    4.The patient has peri-/postpartum cardiomyopathy.
    5.The patient has ischemic or hemorrhagic stroke as diagnosed by CT or MRI within 3 months prior to study enrollment.
    6.The patient has had coronary arterial or peripheral arterial revascularization procedure within 2 months before initiation of screening procedures.
    7.The patient has had IV therapy with diuretic, vasodilator, and/or positive inotropes or aquapheresis within 1 month before initiation of screening procedures, and/or during the screening period.
    8.The patient, who in the absence of an ICD (or any implanted device capable of defibrillation), has a history of malignant ventricular arrhythmia or sustained ventricular tachycardia (VT), with sustained VT demonstrated by QRS complexes wider than 120 milliseconds, lasting more than 30 seconds, and with a rate of more than 100 beats per minute on screening ECG or other data supporting this diagnosis.
    9.The patient has restrictive, obstructive, or infiltrative CM, pericardial constriction, amyloidosis, or uncorrected thyroid disease.
    10.The patient has moderate to severe aortic stenosis as determined by echocardiography-Doppler assessment with a valve area less than 1.0 cm2.
    11.The patient requires valve or other cardiac (eg, pericardectomy) surgery.
    12.The patient has had LV reduction surgery, implanted LVAD, or cardiac transplantation. The patient may be on the cardiac transplant list, but must have low probability of having a transplant procedure over the next 12 months.
    13.The patient has an LV thrombus diagnosed by echocardiography, left ventriculogram, or other imaging.
    14.The patient has cardiogenic shock that is dependent upon mechanical or inotropic support at the time of study intervention (ie, hospitalization on day 0 for index cardiac catheterization with or without intracardiac mapping and cell delivery), as defined by Killip Class IV physiology indicative of cardiogenic shock and/or requirement of intra-aortic balloon pump or IV inotropic support for the maintenance of mean arterial blood pressure at least 60 mmHg.
    15.The patient is known to have unprotected left main coronary artery disease (CAD) greater than 50%.
    16.The patient has known hypersensitivity to radiocontrast media or dimethyl sulfoxide (DMSO), murine, and/or bovine products, with the exception of patients with mild hypersensitivity to radiocontrast media, who may be pretreated with corticosteroids and/or antihistamines
    17.The patient has a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated.
    18.The patient has acute bacterial or viral infectious disease, or acute exacerbation of a chronic infectious disease at the time that day 0 intervention is planned. However, patients with an upper respiratory infection diagnosed at screening that is cleared by day 0 (maximum of 42 days from signing of informed consent form) may undergo the procedure.
    19.Patients with severe chronic obstructive pulmonary disease (COPD) or patients who require home oxygen for any kind of pulmonary disease; home oxygen use as part of CPAP (continuous positive airway pressure) for the indication of sleep apnea in patients living at high altitude is permitted, and as-needed home oxygen use solely as therapy for HF is permitted.
    For full list of Exclusion criteria refer to section 4.2 of Protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure and endpoint for this study is time-to recurrent non-fatal decompensated HF events in the presence of terminal HF-MACE.
    •The diagnosis of a recurrent non-fatal decompensated HF event requires signs and symptoms consistent with clinical decompensation of the patient's HF state. These HF events require use of IV diuretics or aquapheresis during an in-hospital stay or during an outpatient visit.
    •Terminal HF-MACE is defined as a composite of cardiac death, resuscitated cardiac death (including successful firing of an ICD for VF in patients who have an ICD or any implanted device capable of defibrillation), LVAD placement, heart transplant, or artificial heart implantation. Only the first terminal event is accounted for in the primary analysis. All terminal events will be collected and adjudicated for sensitivity analyses.
    For full details please refer to section 3.2 of the protocol
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is an event-driven study and the study duration will be determined by the number of recurrent non-fatal decompensated HF events. Patients are expected to participate in this study until the required number of recurrent non-fatal decompensated HF events occurs. The last patient enrolled must be followed for a minimum of 6 months.
    E.5.2Secondary end point(s)
    The key secondary efficacy measures and endpoints of the study comprise the following:
    •total hospital admissions for non-fatal decompensated HF events after index cardiac catheterization with or without intracardiac mapping and cell delivery
    •total hospital admissions or urgent HF visits for non-fatal decompensated HF events after index cardiac catheterization with or without intracardiac mapping and cell delivery
    •length of in-hospital stay in intensive care unit for decompensated HF
    • rate of recurrent non-fatal decompensated HF events resulting in hospitalization or urgent HF visits
    •cardiac survival (captures only cardiac deaths)
    •overall survival (captures all cause deaths)
    •time-to-first HF-MACE, defined as a composite of terminal HF-MACE (cardiac death, resuscitated cardiac death [including successful firing of an ICD for VF in patients who have an ICD or any implanted device capable of defibrillation], LVAD placement, heart transplant, or artificial heart implantation) or non-fatal decompensated HF event
    •time-to-death from cardiovascular causes, nonfatal MI, nonfatal CVA, coronary revascularization, or hospitalization for unstable angina, whichever comes first
    For full list of secondary end points refer to the Protocol
    E.5.2.1Timepoint(s) of evaluation of this end point
    This is an event-driven study and the study duration will be determined by the number of recurrent non-fatal decompensated HF events. Patients are expected to participate in this study until the required number of recurrent non-fatal decompensated HF events occurs. The last patient enrolled must be followed for a minimum of 6 months.
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Independent Clinical Endpoints Comittee will remain blinded to study treatment for duration of study
    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
    Sham–procedure–controlled study
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belarus
    Bulgaria
    Canada
    France
    Germany
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Russian Federation
    Singapore
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    United States
    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
    Because this study is endpoint driven, the actual duration of the study will be determined by the time required to achieve a minimum of 531 recurrent non-fatal decompensated HF events that have been positively adjudicated by the CEC. Patients are expected to participate in this study until the required number of recurrent non-fatal decompensated HF events occurs. The last patient enrolled must be followed for a minimum of 6 months.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 175
    F.4.2.2In the whole clinical trial 600
    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)
    standard of care
    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 Decision2016-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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