A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease

  • Respiratory Disorder
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • Aarhus
  • Adelaide
  • Athens
  • Aveiro
  • Bad Berka
  • Be'er Sheva
  • Berlin
  • Birmingham
  • Bristol
  • Brno-Bohunice
  • Bruxelles
  • Cambridge
  • Camperdown
  • Chaidari
  • Coimbra
  • Dublin
  • Dublin 4
  • Edinburgh
  • Exeter
  • Firenze
  • Forlì
  • Gdańsk
  • Gießen
  • Haifa
  • Hamilton
  • Heidelberg
  • Hellerup
  • Hlavní město Praha
  • Iraklio
  • Jerusalem
  • Jihlava
  • Kefar Sava
  • L'Hospitalet de Llobregat
  • Leicester
  • Leuven
  • London
  • Madrid
  • Manchester
  • Melbourne
  • Milano
  • Milton
  • Murdoch
  • München
  • New Lambton Heights
  • Odense
  • Olomouc
  • Petah Tikva
  • Porto
  • Rehovot
  • Sanatorio San Luigi
  • Santander
  • Sheffield
  • Southampton
  • Stoke-on-Trent
  • Torrette
  • Vancouver
  • Vila Nova de Gaia
  • Warszawa
  • Woolloongabba
  • Łódź
Trial Identifier:

NCT03099187 2016-002744-17 MA39189

  • A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

    10 Regione Gonzole10043Sanatorio San LuigiItaly
  • A.O.U. Ospedali Riuniti Umberto I -G.M. Lancisi-G. Salesi Ancona; SOD Pneumologia

    71 Via Conca60126TorretteItaly
  • Aarhus Universitetshospital; Lungesygdomme, Forskning

    8200AarhusDenmark
  • Azienda Ospedaliero-Universitaria Careggi; SOD Pneumologia e Fisiopatologia Toracico Polmonare

    50139FirenzeItaly
  • Beilinson Medical Center; Pulmonary Inst.

    39 Jabotinski St4941492Petah TikvaIsrael
  • Carmel Medical Center; Pulmonary Institute

    7 Mikhal St3436212HaifaIsrael
  • CHVNG/E_Unidade 1; Servico de Pneumologia

    S/N R. Conceição Fernandes4434-502Vila Nova de GaiaPortugal
  • Cliniques Universitaires St-Luc

    10 Av. Hippocrate1200BruxellesBelgium
  • Edinburgh Royal Infirmary; Respiratory Department

    51 Old Dalkeith RdEH16 4SAEdinburghUnited Kingdom
  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    27 Lindenberger Weg13125BerlinGermany
  • Fakultni Nemocnice Brno-Bohunice; Klinika Tuberkulozy A Respiracnich Chorob

    20 Jihlavská625 00Brno-BohuniceCzechia
  • Fakultni nemocnice Olomouc; Pneumologicka klinika

    6 I.P. Pavlova779 00OlomoucCzechia
  • Fiona Stanley Hospital; Advanced Lung Disease Unit

    100 Murdoch Dr6150MurdochAustralia
  • Gentofte Hospital, Lungemedicinsk Afdeling

    1 Gentofte Hospitalsvej2900HellerupDenmark
  • Glenfield Hospital

    LE3 9QPLeicesterUnited Kingdom
  • Hadassah Medical Center; Pulmonary Institute

    JerusalemIsrael
  • Hospital Clínico San Carlos - Servicio de Neumologia

    28040MadridSpain
  • Hospital de Sao Joao; Servico de Pneumologia

    4200-319PortoPortugal
  • Hospital Infante D. Pedro; Servico de Pneumologia

    3810-164AveiroPortugal
  • Hospital Universitari de Bellvitge ; Servicio de Neumologia

    s/n Carrer de la Feixa Llarga08907L'Hospitalet de LlobregatSpain
  • Hospital Universitario 12 de Octubre; Servicio de Neumologia

    s/n Av. de Córdoba28041MadridSpain
  • Hospital Universitario La Princesa; Servicio de Neumologia

    62 Calle de Diego de León28006MadridSpain
  • Hospital Universitario Marques de Valdecilla; Servicio de neumologia

    25 Av. de Valdecilla39008SantanderSpain
  • HUC; Servico de Pneumologia A

    3004-561CoimbraPortugal
  • Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc

    26 Płocka01-138WarszawaPoland
  • John Hunter Hospital; Respiratory Department; Respiratory Department

    2305New Lambton HeightsAustralia
  • Kaplan Medical Center

    1 Derech PasternakRehovotIsrael
  • Klinik der Justus-Liebig-Universität; Innere Medizin

    8 Rudolf-Buchheim-Straße35392GießenGermany
  • Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

    15 Marchioninistraße81377MünchenGermany
  • Lung Research Queensland

    11 Finchley St4064MiltonAustralia
  • Mater Misericordiae University hospital

    D07 R2WYDublinIreland
  • Meir Medical Center; Pulmonary Dept

    59 Tchernichovsky St4428164Kefar SavaIsrael
  • Nemocnice Jihlava

    59 Vrchlického586 01JihlavaCzechia
  • Northern General Hospital

    S5 7AUSheffieldUnited Kingdom
  • Odense Universitetshospital, Lungemedicinsk Afdeling J

    4 J. B. Winsløws Vej5000OdenseDenmark
  • Ospedale Morgagni-Pierantoni; U.O. Pneumologia

    34 Via Carlo Forlanini47121ForlìItaly
  • Ospedale San Giuseppe; U.O. di Pneumologia

    12 Via San Vittore20123MilanoItaly
  • Pacifica Lung Research Center/St. Paul's Hospital

    1081 Burrard StV6Z 1Y6VancouverCanada
  • Papworth Hospital NHS Foundation Trust; Respiratory Department

    CB2 0AYCambridgeUnited Kingdom
  • Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

    199 Ipswich Rd4102WoolloongabbaAustralia
  • Respiratory Department

    226 Burgundy St3084HeidelbergAustralia
  • Royal Adelaide Hospital; Respiratory Clinical Trials Unit, Thoracic Medicine

    5000AdelaideAustralia
  • Royal Brompton Hospital; Respiratory Department

    SW3 6NPLondonUnited Kingdom
  • Royal Devon and Exeter Hospital (Wonford)

    EX2 5DWExeterUnited Kingdom
  • Royal Prince Alfred Hospital

    50 Missenden Rd2050CamperdownAustralia
  • Royal Stoke University Hospital

    ST4 6QGStoke-on-TrentUnited Kingdom
  • Shaare Zedek Medical Center; Pulmonary Inst.

    12 Shmu'el Bait St9103102JerusalemIsrael
  • Soroka; Pulmonary Clinic

    151 Yitzhack I. Rager BlvdBe'er ShevaIsrael
  • Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology

    152 Mesogion115 27AthensGreece
  • Southampton University Hospitals NHS Trust

    SO16 6YDSouthamptonUnited Kingdom
  • Southmead Hospital; Respiratory Department

    BS10 5NBBristolUnited Kingdom
  • St Vincents University Hospital

    D04 T6F4Dublin 4Ireland
  • St. Joseph's Healthcare Hamilton

    50 Charlton Ave EL8N 4A6HamiltonCanada
  • The Alfred Hospital

    55 Commercial Rd3004MelbourneAustralia
  • Thoraxklinik Heidelberg gGmbH

    1 Röntgenstraße69126HeidelbergGermany
  • ULB Hôpital Erasme

    808 Rte de Lennik1070BruxellesBelgium
  • University College London Hospital; Respiratory Medicine

    235 Euston RdNW1 2BULondonUnited Kingdom
  • University General Hospital of Athens "Attikon", B' University Pulmonary Clinic

    1 Rimini124 62ChaidariGreece
  • University General Hospital of Heraklio, Pulmonary Clinic

    IraklioGreece
  • University Hospital Birmingham Queen Elizabeth Hospital

    B15 2GWBirminghamUnited Kingdom
  • Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

    22 Dr. Stefana Kopcińskiego90-153ŁódźPoland
  • Uniwersyteckie Centrum Kliniczne;Klinika Alergologii i Pneumonologii

    17 Mariana Smoluchowskiego80-214GdańskPoland
  • UZ Leuven Gasthuisberg

    49 Herestraat3000LeuvenBelgium
  • Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci

    499/2 U Nemocnice121 11Hlavní město PrahaCzechia
  • Wythenshawe Hospital; North West Lung Research Centre

    M23 9GFManchesterUnited Kingdom
  • Zentralklinik Bad Berka GmbH; Pneumologie

    9 Robert-Koch-Allee99438Bad BerkaGermany
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    The purpose of this study is to evaluate the efficacy and safety of pirfenidone in participants with fibrosing interstitial lung disease (ILD) who cannot be classified with moderate or high confidence into any other category of fibrosing ILD by multidisciplinary team (MDT) review ("unclassifiable" ILD).

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT03099187, MA39189, 2016-002744-17 Trial Identifier
    Pirfenidone, Placebo Treatments
    Lung Diseases, Interstitial Condition
    Official Title

    Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD

    Eligibility Criteria

    gender
    All Gender
    age
    ≥18 Years & ≤ 85 Years Age
    healthy-volunteers
    No Healthy Volunteers
    Inclusion Criteria
    • Age >= 18-85 years
    • Confirmed fibrosing ILD which, following multidisciplinary team review, cannot be classified with either high or moderate confidence as a specific idiopathic interstitial pneumonia or other defined ILD
    • Progressive disease as considered by the investigator as participants deterioration within the last 6 months, which is defined as a rate of decline in forced vital capacity (FVC) >5% or a significant symptomatic worsening not due to cardiac, pulmonary vascular or other causes
    • Extent of fibrosis >10% on high-resolution computed tomography
    • Forced vital capacity >= 45% of predicted value
    • Diffusing capacity of the lung for carbon monoxide (DLco) >= 30% of predicted value
    • Forced expiratory volume in 1 second/FVC ratio >= 0.7
    • Able to do 6-minute walk distance (6MWD) >= 150 meters
    • For women of childbearing potential: agreement to remain abstinent or use a non-hormonal or hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of pirfenidone
    • For men, agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
    Exclusion Criteria
    • Diagnosis with moderate or high confidence of nonspecific interstitial pneumonia and any ILD with an identifiable cause such as connective tissue disease-ILD, chronic hypersensitivity pneumonitis, or others
    • Diagnosis of idiopathic pulmonary fibrosis independent of the confidence level
    • History of unstable angina or myocardial infarction during the previous 6 months
    • Treatment with high dose systemic corticosteroids, or any immunosuppressant other than mycophenolate mofetil/acid (MMF), at any time within the 4 weeks of the screening period. Participants being treated with MMF should be on a stable dose that is expected to remain stable throughout the trial and was started at least 3 months prior to screening
    • Participants previously treated with pirfenidone or nintedanib
    • Participants treated with N-acetyl-cysteine for fibrotic lung disease, at any time within the 4 weeks of the screening period
    • Drug treatment for any type of pulmonary hypertension
    • Participation in a trial of an investigational medicinal product within the last 4 weeks
    • Significant other organ co-morbidity including hepatic or renal impairment
    • Predicted life expectancy < 12 months or on an active transplant waiting list
    • Use of any tobacco product in the 12 weeks prior to the start of screening, or any unwillingness to abstain from their use through to the Follow-up Visit
    • Illicit drug or alcohol abuse within 12 months prior to screening
    • Planned major surgery during the trial
    • Hypersensitivity to the active substance or to any of the excipients of pirfenidone
    • History of angioedema
    • Concomitant use of fluvoxamine
    • Clinical evidence of any active infection
    • Any history of hepatic impairment, elevation of transaminase enzymes, or liver function test results as: Total bilirubin above the upper limit of normal (ULN), Aspartate aminotransferase or alanine aminotransferase >1.5 × ULN, and Alkaline phosphatase >2.0 × ULN
    • Creatinine clearance < 30 milliliter (mL) per minute, calculated using the Cockcroft-Gault formula
    • Any serious medical condition, clinically significant abnormality on an Electrocardiogram (ECG) at screening, or laboratory test results
    • An ECG with a heart rate corrected QT interval using Fridericia's formula as >= 500 milliseconds at screening, or a family or personal history of long QT syndrome

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