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    Summary
    EudraCT Number:2013-002893-35
    Sponsor's Protocol Code Number:CP027.2002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2013-002893-35
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
    Randomizált, kettős vak, placebo kontrollos, dóziskereső vizsgálat a TRV027 hatásosságának kutatására akut dekompenzált szívelégtelen betegek körében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Explore the Efficacy of TRV027 in Patients Hospitalized for Acute Decompensated Heart Failure
    A.4.1Sponsor's protocol code numberCP027.2002
    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 SponsorTrevena 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 supportTrevena Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTrevena Inc.
    B.5.2Functional name of contact pointPamela Swiggard
    B.5.3 Address:
    B.5.3.1Street Address1018 West 8th Avenue, Suite A
    B.5.3.2Town/ cityKing of Prussia, PA
    B.5.3.3Post code19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number6103548840233
    B.5.5Fax number6103548850
    B.5.6E-mailpswiggard@trevenainc.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 nameTRV027
    D.3.2Product code TRV027
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall safety and efficacy of TRV027 when administered in addition to standard of care (SOC) on mortality, morbidity, dyspnea, and length of stay in patients hospitalized with Acute Decompensated Heart Failure (ADHF).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of TRV027when administered in addition to SOC in relieving dyspnea and congestion in patients with ADHF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients may be included in the study if all of the following criteria are met:
    1. Men or women aged ≥21 years and ≤ 85 years
    a. Women of non-child-bearing potential must have:
    i. Documentation of surgical sterilization (hysterectomy and/or bilateral oophorectomy)
    OR
    ii. Experienced menopause: no menses for >12 months
    b. Women of child bearing potential must have a:
    i. A negative pregnancy test, AND
    ii. Have had their most recent menstrual period ≥ 2 weeks prior to presentation
    2. Able to provide written informed consent
    3. Reported pre-existing diagnosis of heart failure with no hospitalization for heart failure within 30 days prior
    to screening. Heart failure must be treated for at least 30 days prior to screening with daily oral loop diuretics
    plus ACE inhibitors and/or beta-adrenergic blockers for patients for whom ACE inhibitors and betaadrenergic
    blockers are not documented as contraindicated.
    4. Systolic blood pressure ≥105 mmHg and ≤160 mmHg within 30 minutes of randomization
    5. Ventricular rate ≤125 bpm. Patients with rate-controlled persistent or permanent atrial fibrillation (aFib) at
    screening are permitted.
    6. Presence of ADHF defined by:
    o BNP > 400 pg/mL or NT-proBNP > 1600 pg/mL
     For patients with BMI >30 kg/m2: BNP > 200 pg/mL or NT-proBNP > 800 pg/mL
     For patients with rate-controlled persistent or permanent aFib: BNP > 600 pg/mL or NTproBNP
    > 2400 pg/mL
    o AND congestion on chest radiograph (CXR)
    o AND at least two (2) of the following:
     Rales by chest auscultation
     Edema ≥ +1 on a 0-3+ scale, indicating indentation of skin with mild digital pressure that
    requires 10 or more seconds to resolve in any dependent area including extremities or
    sacral region.
     Elevated jugular venous pressure (≥8 cm H2O)
    7. Receipt of a IV loop diuretic at a minimum dose 40 mg furosemide (or equivalent loop diuretic) for the
    treatment of dyspnea due to ADHF at least 1 hour prior to anticipated randomization and the initiation of
    study medication
    8. Patient report of dyspnea at rest or upon minimal exertion during screening at least one hour after
    administration of IV loop diuretic.
    E.4Principal exclusion criteria
    Patients will be excluded if any of the following apply:
    1. Women who are pregnant or breast-feeding
    2. Clinical presentation:
    a. Suspected acute coronary syndrome (ACS) based on clinical judgment. NOTE: the presence of elevated
    troponin concentrations in the absence of other clinical findings, is not sufficient for a diagnosis of ACS
    b. Coronary revascularization in the 3 months prior to screening or planned during current admission
    c. Temperature >38.5oC (oral or equivalent) or suspected sepsis or active infection requiring IV
    antimicrobial treatment
    d. Clinically significant anemia (hematocrit < 25%)
    e. Serum sodium >145 mEq/L (145 mmol/L)
    f. Current or planned ultrafiltration, paracentesis, thoracentesis, hemofiltration or dialysis at time of
    screening
    g. Any mechanical ventilation requiring tracheal intubation and sedation at the time of screening or during
    the current hospitalization
    h. CPAP/BiPAP discontinued less than 1 hour prior to randomization, unless prescribed for treatment of
    sleep apnea and used for >3 months
    i. History or current use of left ventricular assist devices (LVADs) or history of use of an intra-aortic
    balloon pump (IABP) within the last year
    j. Administration of intravenous radiographic contrast agent within 72 hours prior to screening or presence
    of acute contrast induced nephropathy at the time of screening
    k. Presence of clinically significant arrhythmia that, in the Investigator’s opinion, is the primary cause of
    worsening heart failure symptoms, including ventricular tachycardia or bradyarrhythmia with ventricular
    rate <45 bpm
    l. Uncertainty about ability to complete follow up including (but not limited to) alcoholism, severe drug
    abuse, homelesness, unknown or uncertain residency status, etc.
    3. Medications:
    a. Use of intravenous nitroprusside or nesiritide within 2 hours prior to randomization
    b. Intravenous nitrates (nitroglycerin at a dose > 0.1 mg/kg/hr or equivalent) or any IV nitrates if the
    patient’s screening systolic blood pressure is < 150 mmHg within 1 hour prior to randomization
    c. Use for at least 4 hours or planned use of inotropes (milrinone, levosimendan, dobutamine, or
    >2.5 mcg/kg/min dopamine), within 48 hours prior to randomization or any use of IV inotropes or
    vasopressors within 2 hours prior to randomization
    d. Use of angiotensin receptor blocking drugs (ARBs) within 7 days of prior to randomization. Angiotensin
    converting enzyme (ACE) inhibitors are permitted.
    e. Use of any investigational medication within 30 days or 5 terminal elimination half-lives (whichever is
    longer) prior to randomization
    f. As determined by the Investigator, clinically significant hypersensitivity or allergy to, or intolerance of,
    angiotensin receptor blockers
    4. Medical history:
    a. Any significant pulmonary disease that requires steroids IV or inhalation therapy, that is known to
    significantly affect pulmonary function tests or led in the past to respiratory failure
    b. Major surgery within 8 weeks prior to screening
    c. Stroke within 3 months prior to screening
    d. eGFR (sMDRD) <20 mL/min/1.73m2 or >75 mL/min/1.73m2 between presentation and randomization
    e. Post cardiac or renal transplant
    f. Listed for renal transplant or cardiac transplant with anticipated transplant time to transplant < 6 months
    g. History of severe left ventricular outlet obstruction (either valvular or sub-valvular), severe mitral valve
    stenosis or any other surgically correctable valvular disease as the primary cause of AHF, with the
    exception of mitral regurgitation secondary to LV dilation
    h. Complex congenital heart disease
    i. Diagnosis of hypertrophic or restrictive cardiomyopathy
    j. In the opinion of the Investigator, significant pulmonary or hepatic disease that could interfere with the
    evaluation of safety or efficacy of TRV027
    k. In the opinion of the Investigator, has a life expectancy of less than 6 months including significant
    malignant or premalignant condition known to substantially limit prognosis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical endpoint is a composite of the following outcomes: (1) time from randomization to death through day 30, (2) time from randomization to heart failure re-hospitalization through day
    30, (3) time from randomization to worsening heart failure (WHF, see Section 6.4) through day 5, (4) change in dyspnea VAS score (calculated area under the curve) from baseline through day 5, and (5) length of initial hospital
    stay (in days) from randomization. The component outcomes will be combined by deriving an average Z for each
    patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are (1) The change in dyspnea VAS scores (calculated area under the curve representing the change from baseline over time) from baseline through day 5, (2) the change in centrally-measured NT-proBNP from baseline to 48 hours, and (3) average Z comprising the components of the
    primary endpoint and incorporating changes in troponin-T and cystatin-C from baseline to 48 hours.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 5
    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 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) 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 trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Argentina
    Bulgaria
    Canada
    Czech Republic
    Germany
    Hungary
    Israel
    Poland
    Romania
    Russian Federation
    Slovakia
    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
    Last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 155
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 465
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 620
    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)
    Study design is adjunct treatment with standard of care, no further provision are planned.
    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 Decision2013-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-26
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