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    Summary
    EudraCT Number:2006-002875-42
    Sponsor's Protocol Code Number:1199.30
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2006-002875-42
    A.3Full title of the trial
    A 12 month, double blind, randomized, placebo-controlled trial evaluating the effect of BIBF 1120 administered at oral doses of 50 mg qd, 50 mg bid, 100 mg bid and 150 mg bid on Forced Vital Capacity decline during one year, in patients with Idiopathic Pulmonary Fibrosis, with optional active treatment extension until last patient out.
    Studio di 12 mesi, in doppio cieco, randomizzato, controllato verso placebo per valutare l effetto di BIBF 1120 somministrato a dosi orali di 50 mg una volta al giorno, 50 mg due volte al giorno, 100 mg due volte al giorno e 150 mg due volte al giorno sul declino della capacita` vitale forzata durante un anno, in pazienti con fibrosi polmonare idiopatica, con estensione facoltativa del trattamento attivo fino al termine dell ultimo paziente.
    A.4.1Sponsor's protocol code number1199.30
    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 ING.
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameNA
    D.3.2Product code BIBF 1120 ES
    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.3.9.1CAS number 626247-18-6
    D.3.9.2Current sponsor codeBIBF 1120 ES
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 (IPF)
    fibrosi polmonare idiopatica (FPI)
    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 14.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).
    L'obiettivo primario e' dimostrare se almeno una strategia di dosaggio sia superiore a placebo nel modificare il declino della capacita' vitale forzata in pazienti con fibrosi polmonare idiomatica (FPI).
    E.2.2Secondary objectives of the trial
    Additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy
    Verranno indagati alcuni parametri aggiuntivi,al fine di differenziare tra strategie di dosaggio sulla base di tollerabilita' ed efficacia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient >= 40 years - Written informed consent signed prior to entry into the study - IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit. - HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis. - FVC >= 50 % of predicted value Predicted normal values will be calculated according to ESCS: Males : FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34 Females : FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89 - Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted . Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline.Adjustment for haemoglobin: Males : DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb]) Females : DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g·dL-1 - PaO2 >= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air
    - Eta` &gt;= 40 anni. - Consenso informato rilasciato per iscritto prima del reclutamento nello studio. -Diagnosi di IPF (secondo i criteri ATS/ERS) negli ultimi 5 anni precedenti la vista di screening. - Tomografia computerizzata ad alta risoluzione entro 12 mesi dalla randomizzazione e biopsia (questa ultima se richiesta per soddisfare i criteri ATS/ERS) valutata centralmente e consistente con la diagnosi. - Capacita` vitale forzata FVC &gt;= 50% del teorico. Valori teorici secondo ESCS: Maschi: FVC teorico (L) = 5.76 x altezza (metri)- 0.026 x eta` (anni) -4.34 Femmine : FVC teorico (L) = 4.43 x altezza (metri)- 0.026 x eta` (anni) -2.89 6.DLCO singola (corretta per Hb) 30 - 79% comprensiva del teorico. Centri differenti possono usare formule differenti, sulla base del metodo usato per misurare il DLCO. In ogni caso, il metodo deve essere in accordo con la linea guida ATS/ERS. Aggiustamento per Hb: Maschi : DLCO teorico per Hb = DLCO teorico x (1.7Hb/[10.22+Hb]) Femmine : DLCO teorico per Hb = DLCO teorico x (1.7Hb/[9.38+Hb]) dove Hb e` espressa in g dL-1 - Pa O2 &gt;= 55 mmHg (dal livello del mare a 1500 m) o 50 mmHg (&gt; 1500 m slm) aria.
    E.4Principal exclusion criteria
    - AST, ALT > 1.5 x ULN at screening (visit 1). - Bilirubin > 1.5 x ULN at screening (visit 1). - Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7) at screening(visit 1). - Continuous oxygen supplementation at randomisation (defined as >= 15 hours supplemental oxygen per day). - Active infection at screening or randomisation. - Neutrophils < 1500 / mm3 at screening(visit 1). - International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN at screening (visit 1). - Platelets < 100 000 /mL at screening (visit 1). - Haemoglobin < 9.0 g/dL at screening (visit 1). - In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation). - Life expectancy for disease other than IPF < 2.5 years (Investigator assessment). - Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial. Myocardial infarction during the previous 6 months Unstable angina during the previous month - Other investigational therapy received within 8 weeks prior to screening visit. - Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment (highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner). Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. - Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential). - Known or suspected active alcohol or drug abuse. - Bleeding risk Known inherited predisposition to bleeding. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc). Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy. History of hemorrhagic CNS event within 12 months prior to screening (visit 1). Any of the following within 3 months prior to screening (visit 1): -Gross / frank haemoptysis or haematuria -Active gastro-intestinal bleeding or ulcers -Major injury or surgery. - Thrombotic risk Known inherited predisposition to thrombosis. History of thrombotic event (including stroke and transient ischemic attacks) within 12 months prior to screening (visit 1). - Surgical procedures planned to occur during trial period. - Coagulopathy. - Uncontrolled systemic arterial hypertension.
    - AST, ALT &gt; 1.5 x limite superiore di normalita` allo screening (visita 1). Bilirubina &gt; 1.5 x limite superiore di normalita` allo screening (visita 1). - Ostruzione aerea rilevante (FEV1/capacita` vitale forzata &lt; 0.7 prima dei broncodilatatori) allo screening (visita 1). -Supplementazione continua di ossigeno alla randomizzazione (&gt;= 15 ore/die). - Stato di infezione allo screening o alla randomizzazione. 6.Neutrofili &lt; 1500 / mm3 allo screening (visita 1). - Rapporto internazionale normalizzato (INR) &gt; 1.5 e/o tempo parziale di tromboplastina (PTT) &gt; 1.5 x limite superiore di normalita` allo screening (visita 1). - Piastrine &lt; 100 000 /mL at screening (visit 1). - Emoglobina &lt; 9.0 g/dL allo screening (visita 1). - Paziente da trapiantare durante lo studio, a giudizio dello Sperimentatore (la presenza nella lista per il trapianto e` accettabile per l arruolamento). - Aspettativa di vita per malattie diverse dalla IPF &lt; 2.5 anni (valutazione dello Sperimentatore). - Altre malattie che possano interferire con le procedure o a giudizio dello Sperimentatore possano interferire con la partecipazione allo studio o possano mettere il paziente a rischio in caso di partecipazione allo studio: Infarto del miocardio nei 6 mesi precedenti Angina instabile nel mese precedente - Altre terapie sperimentali ricevute nelle precedenti 8 settimane prima della visita di screening. - Donne che allattano o in eta` fertile che non usano un metodo anticoncezionale altamente efficace per almeno un mese prima dell arruolamento [i metodi anticoncezionali altamente efficaci sono quelli con basso tasso di insuccesso (meno del 1% per anno), come impianti, iniettabili, contraccettivi orali associati, alcune spirali, astinenza o vasectomia]. Le donne sono considerate in eta` fertile se non sterilizzate chirurgicamente, o non sottoposte a legatura delle tube, o in postmenopausa da almeno 2 anni. - Maschi sessualmente attivi che non accettano di usare il preservativo durante lo studio (salvo che la partner non sia a rischio di gravidanza. - Abuso attivo di alcool o droghe noto o sospetto. - Rischio di sanguinamento: Predisposizione nota ereditaria al sanguinamento Necessita` di anticoagulanti a dose piena (antagonisti della vitamina K, eparina, irudina) Necessita` di antiaggreganti piastrinici a dose piena (ASA, clopidogrel) Anamnesi di eventi emorragici del SNC nei 12 mesi precedenti lo screening (visita 1) Qualsiasi delle condizioni seguenti entro 3 mesi prima dello screening (visita 1): -emottisi severa/franca o ematuria -emorragia o ulcera gastrointestinale -trauma o chirurgia maggiori. - Rischio trombotico: Predisposizione ereditaria nota alla trombosi Anamnesi di eventi trombotici (compresi TIA e ictus) nei 12 mesi precedenti lo screening (visita 1). - Procedure chirurgiche programmate durante lo studio. - Coagulopatie. - Ipertensione arteriosa sistemica non controllata.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the rate of decline in FVC (expressed in mL per year), evaluated from baseline until 12 month of treatment, compared to placebo.
    L'end point primario e' il declino della capacita' vitale forzata, confrontato a placebo. La capacita' vitale forzata verra' misurata mediante tests spirometrici.
    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 Yes
    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 trial5
    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 concerned11
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months40
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months40
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 550
    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 Decision2007-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-14
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