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    Summary
    EudraCT Number:2013-001613-33
    Sponsor's Protocol Code Number:BRIDGE
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-001613-33
    A.3Full title of the trial
    Iloprost for Bridging to Heart Transplantation in Patients with Pulmonary Hypertension and Left Heart Failure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Inhaltion of Iloprost to stabilize or improve patient´s medical condition due to pulmonary hypertension caused by left heart failure prior to heart transplantation.
    Gabe von Iloprost zur Stabilisierung bzw. Verbesserung des Gesundheitszustandes bei Patienten mit Lungenhochdruck hervorgerufen durch Linksherzversagen bei bevorstehender Herztransplantation
    A.3.2Name or abbreviated title of the trial where available
    BRIDGE
    A.4.1Sponsor's protocol code numberBRIDGE
    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 SponsorThoraxclinic at the University of Heidelberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer HealthCare Pharmaceuticals
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Pulmonary Hypertension
    B.5.2Functional name of contact pointEkkehard Grünig
    B.5.3 Address:
    B.5.3.1Street AddressAmalienstraße 5
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69126
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962213968053
    B.5.5Fax number+4962213961209
    B.5.6E-mailekkehard.gruenig@med.uni-heidelberg.de
    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 Yes
    D.2.1.1.1Trade name Ventavis
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameVentavis
    D.3.2Product code Q4074
    D.3.4Pharmaceutical form Nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNILOPROST TROMETAMOL
    D.3.9.1CAS number 78919-13-8
    D.3.9.4EV Substance CodeSUB14185MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 placeboNebuliser solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary Hypertension and Left Heart Failure
    E.1.1.1Medical condition in easily understood language
    High blood pressure in the lungs due to left 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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10024106
    E.1.2Term Left heart failure
    E.1.2System Organ Class 100000004849
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10037406
    E.1.2Term Pulmonary hypertension secondary
    E.1.2System Organ Class 100000004855
    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 efficacy and safety of inhaled Iloprost in treatment of naïve patients with left heart failure and pulmonary hypertension (PH), who are on the waiting list for orthotopic heart transplantation. The primary efficacy endpoint will be the change from baseline to week 12/day 85 in Pulmonary Vascular Resistance (PVR).
    E.2.2Secondary objectives of the trial
    Secondary objectives are preserving quality of life and preventing worsening of any other organ functions induced by Left Heart Failure and Pulmonary Hypertension.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female and male patients of any racial origin with left heart insufficiency and secondary Pulmonary Hypertension
    - Having fulfilled his/her 18th birthday on Visit 1 (Day -7 to -1) of the study
    - Written informed consent (must be available before enrollment in the trial)
    - Modified WHO functional class III-IV
    - Pulmonary Hypertension diagnosed by right heart catheter showing:
    o Baseline mean pulmonary arterial pressure (mPAP) > 25 mmHg
    o Baseline pulmonary vascular resistance (PVR) > 230 dyn x s x cm-5
    o Baseline transpulmonary gradient (TPG) > 15 mm Hg
    - Echocardiogram on Visit 1/Day -7 to -1 consistent with secondary PH, specifically evidence of right ventricular hypertrophy or dilation, and absence of mitral valve stenosis
    - Patients receiving maximal conventional left heart failure therapy including intensified treatment with diuretics and have been stable for at least 2 months before entering the study
    - Except for diuretics, vasodilators and antihypertensives, medical treatment should not be expected to change during the entire 12-week study period.
    - Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the study for women with child-bearing potential
    - Able to understand and sign the Informed Consent Form
    - Ability of subject to understand character and individual consequences of the clinical trial
    E.4Principal exclusion criteria
    - Pulmonary Hypertension of any cause other than permitted in the entry criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease based on pulmonary oedema during a previous vasoreactivity test or on abnormal findings compatible with that diagnosis (septal lines or pulmonary edema previously detected at high resolution computer tomography), congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
    - Contraindication for right heart catheterization
    - Severe lung disease: FEV1/FVC <0.5 and total lung capacity < 70% of the normal value
    - Any subject who had received any investigational medication within 4 weeks prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
    - Any PAH-specific medication (ERAs, PDE-5-I, Prostacyclins) during the last 30 days prior to inclusion (randomization).
    - Known intolerance to inhalation treatment
    - Conditions where the effects of inhaled Iloprost on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, and intracranial haemorrhage)
    - Severe coronary heart disease or unstable angina, myocardial infarction within the last six months
    - Cerebrovascular events (e.g. transient ischemic attack, stroke) within the last 3 months
    - Active liver disease, porphyria or elevations of serum transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
    - Hemoglobin concentration of less than 75 % of the lower limit of normal
    - Systolic blood pressure < 85 mmHg
    - History or suspicion of inability to cooperate adequately
    - Pregnancy and lactation
    - History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in pulmonary vascular resistance (PVR) at Day 85 versus baseline determined meassured by right heart catheter (RHC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study
    E.5.2Secondary end point(s)
    - Hemodynamic parameters determined by right heart catheter as cardiac output, cardiac index, PAP, PCWP, RA-pressure
    - Echographie values (RA-area, RV-area, Tei, TAPSE, PASP)
    - 6-minute walking distance
    - Quality of life (QoL: SF-36, CAMPHOR)
    - Laboratory parameters: Hemoglobin, hematocrit, AST, ALT, Bilirubin, CRP, sodium, creatinin clearance, NTproBNP)
    - WHO functional class
    - Need for resucue medication (Borsentan)
    - Safety parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 Yes
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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 months6
    E.8.9.1In the Member State concerned days
    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: 40
    F.1.3Elderly (>=65 years) No
    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 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 state40
    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)
    After 12 weeks treatment, therapy with Iloprost may be prescribed to all patients who might benefit from the treatment with inhaled Iloprost. This decision will be based on the physician’s and the patient’s estimation. Patient care and monitoring will be performed in the patients’ specialized centres.
    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 Decision2014-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-03-17
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