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    The EU Clinical Trials Register currently displays   44015   clinical trials with a EudraCT protocol, of which   7317   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:2010-024252-29
    Sponsor's Protocol Code Number:1199.34
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-024252-29
    A.3Full title of the trial
    A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)
    Ensayo Clínico aleatorizado, doble ciego, controlado con placebo, de 52 semanas de duración, para evaluar el efecto de 150 mg de BIBF 1120 oral, dos veces al día, en la caída anual de la Capacidad Vital Forzada en pacientes con Fibrosis Pulmonar Idiopática.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    -
    A.4.1Sponsor's protocol code number1199.34
    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 SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 supportBoehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1-800-243-0127
    B.5.5Fax number+1-800-821-7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBIBF 1120
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNBIBF1120
    D.3.9.1CAS number --
    D.3.9.2Current sponsor codeBIBF 1120
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 nameBIBF 1120
    D.3.2Product code BIBF 1120
    D.3.4Pharmaceutical form Capsule, soft
    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 INNBIBF1120
    D.3.9.1CAS number --
    D.3.9.2Current sponsor codeBIBF 1120
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    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
    Idiopathic Pulmonary Fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    Fibrosis pulmonar idiopática
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).
    Demostrar la reducción del deterioro de la función pulmonar, medida a través del cambio de la tasa anual de descenso de la capacidad vital forzada (FVC).
    E.2.2Secondary objectives of the trial
    To assess the patient?s perception of his/her disease, and the time to IPF exacerbation.
    To investigate respiratory and overall survival, as well as causes of mortality.
    To assess safety and tolerability.
    Evaluar la percepción del paciente de su enfermedad, y el tiempo hasta la exacerbación de la FPI.
    Investigar la supervivencia respiratoria y global, así como las causas de mortalidad.
    Evaluar la seguridad y la tolerabilidad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient aged ? 40 years
    IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline (in press) for diagnosis and management, within 5 years of visit 2.
    Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
    Dlco (corrected for Hb [visit 1]): 30%-79% predicted of normal
    FVC ? 50% predicted of normal
    Edad del paciente > o = 40 años
    FPI diagnosticada, según las directrices ATS/ERS/JRS/ALAT IPF más recientes para el diagnóstico y el tratamiento, en los 5 años previos a visita 2.
    La combinación del patrón del HRCT, y si está disponible el patrón de la biopsia pulmonar quirúrgica, según la evaluación de los examinadores centrales, es concordante con el diagnóstico de FPI
    Dlco (corregida por la Hb): 30%-79% del normal teórico
    FVC > o = 50% del normal teórico
    E.4Principal exclusion criteria
    Laboratory parameters AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN.
    Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7).
    In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation).
    Myocardial infarction within 6 months of visit 2.
    Unstable angina within 1 month of visit 2.
    Bleeding risk (Known genetic predisposition, fibrinolysis, full-dose therapeutic anticoagulation or high dose antiplatelet therapy, history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery.
    Thrombotic risk (known inherited predisposition to thrombosis, history of thrombotic event (including stroke and transient ischemic attacks) within 12 months, International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN.
    NAC, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1.
    Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1.
    Parámetros de laboratorio: AST, ALT > 1,5 x LSN.; Bilirrubina > 1,5 x LSN.
    Obstrucción relevante de las vías respiratorias (FEV1/FVC < 0,7 prebroncodilatador).
    A juicio del investigador, es posible que el paciente se someta a un transplante de pulmón durante el estudio (pero figurar en la lista de trasplantes es aceptable para la participación).
    Infarto de miocardio durante los 6 meses previos a Visita 2
    Angina inestable durante el mes previo a Visita 2
    Riesgo de hemorragia (predisposición genética, fibrinólisis o anticoagulación terapéutica a dosis completa o tratamiento de antiagregación plaquetaria a dosis altas; antecedente de episodio hemorrágico del SNC en los 12 meses; hemoptisis o hematuria o hemorragia gastrointestinal activa o úlceras o lesión o cirugía mayor en los 3 meses previos
    Riesgo trombótico (predisposición hereditaria, antecedente de episodio trombótico (incluido ictus y accidente isquémico transitorio) antes de 12 meses, índice internacional normalizado (INR) > 2, prolongación del tiempo de protrombina (TP) y tiempo de tromboplastina parcial (TTP) en > 50% del LSN institucional.
    N-Acetil Cisteina, prednisona > 15mg/día o equivalente recibido en las 2 semanas previas a la visita 1
    Pirfenidona, azatioprina, ciclofosfamida, ciclosporina A recibida en las últimas 8 semanas desde la visita 1
    E.5 End points
    E.5.1Primary end point(s)
    The annual rate of decline in FVC (expressed in ml during 52 weeks)
    Tasa anual de descenso en la FVC (expresada en ml durante 52 semanas)
    E.5.1.1Timepoint(s) of evaluation of this end point
    -
    E.5.2Secondary end point(s)
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    -
    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 Yes
    E.6.12Pharmacoeconomic Yes
    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 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 trial3
    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 EEA42
    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
    Canada
    Chile
    China
    Finland
    France
    Germany
    Greece
    India
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Portugal
    Russian Federation
    Spain
    Turkey
    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
    The study will end when the last patient has completed the 52 weeks of treatment and the follow-up period of 28 days
    El estudio finalizará cuando el último paciente haya completado sus 52 semanas de tratamiento y el período de seguimiento de 28 días.
    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 months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 151
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 485
    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 who have completed the 52-week treatment period will be offered to go into a rollover study where they all will receive the active drug (full dose or reduced dose in case the dose was reduced during the study period)
    A los pacientes que hayan alcanzado la visita de la semana 52 se les ofrecerá un estudio de extensión en el que todos recibirán el fármaco activo
    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 Decision2011-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2003-10-15
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