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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03099187
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, Czechia, Denmark, Germany, Greece, Ireland, Israel, Italy, Poland, Portugal, Spain, United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lung Diseases, Interstitial

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Status

Active, not recruiting

Address

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050

New Lambton Heights, New South Wales, Australia

Status

Active, not recruiting

Address

John Hunter Hospital; Respiratory Department; Respiratory Department

New Lambton Heights, New South Wales, 2305

Northside Heart and Lung, Chermside, Queensland, Australia

Status

Active, not recruiting

Address

Northside Heart and Lung

Chermside, Queensland, 4032

Woolloongabba, Queensland, Australia

Status

Active, not recruiting

Address

Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine

Woolloongabba, Queensland, 4102

Adelaide, South Australia, Australia

Status

Active, not recruiting

Address

Royal Adelaide Hospital; Respiratory Clinical Trials Unit, Thoracic Medicine

Adelaide, South Australia, 5000

Heidelberg, Victoria, Australia

Status

Active, not recruiting

Address

Bowen Centre Austin Health; Institute for Breathing and Sleep

Heidelberg, Victoria, 3084

The Alfred Hospital, Prahan, Victoria, Australia

Status

Active, not recruiting

Address

The Alfred Hospital

Prahan, Victoria, 3181

Murdoch, Western Australia, Australia

Status

Active, not recruiting

Address

Fiona Stanley Hospital; Advanced Lung Disease Unit

Murdoch, Western Australia, 6150

ULB Hôpital Erasme, Brussels, Belgium

Status

Active, not recruiting

Address

ULB Hôpital Erasme

Brussels, , 1070

Cliniques Universitaires St-Luc, Bruxelles, Belgium

Status

Active, not recruiting

Address

Cliniques Universitaires St-Luc

Bruxelles, , 1200

UZ Leuven Gasthuisberg, Leuven, Belgium

Status

Active, not recruiting

Address

UZ Leuven Gasthuisberg

Leuven, , 3000

Vancouver, British Columbia, Canada

Status

Active, not recruiting

Address

St. Paul's Hospital University of British Colambia Division of Hematology

Vancouver, British Columbia, V6Z 1Y6

St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada

Status

Active, not recruiting

Address

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6

CHUM Hôpital Notre-Dame, Montreal, Quebec, Canada

Status

Withdrawn

Address

CHUM Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1

Ste. Foy, Quebec, Canada

Status

Active, not recruiting

Address

Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)

Ste. Foy, Quebec, G1V 4G5

Brno, Czechia

Status

Active, not recruiting

Address

Fakultni Nemocnice Brno-Bohunice; Klinika Tuberkulozy A Respiracnich Chorob

Brno, , 639 00

Nemocnice Jihlava, Jihlava, Czechia

Status

Active, not recruiting

Address

Nemocnice Jihlava

Jihlava, , 58633

Olomouc, Czechia

Status

Active, not recruiting

Address

Fakultni nemocnice Olomouc; Pneumologicka klinika

Olomouc, , 775 20

Praha 2, Czechia

Status

Recruiting

Address

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

Praha 2, , 128 08

Aarhus C, Denmark

Status

Active, not recruiting

Address

Aarhus Universitetshospital, Lungemedicinsk Afd. LUB

Aarhus C, , 8000

Hellerup, Denmark

Status

Recruiting

Address

Gentofte Hospital, Lungemedicinsk Afdeling

Hellerup, , 2900

Odense C, Denmark

Status

Active, not recruiting

Address

Odense Universitetshospital, Lungemedicinsk Afdeling J

Odense C, , 5000

Bad Berka, Germany

Status

Active, not recruiting

Address

Zentralklinik Bad Berka GmbH; Pneumologie

Bad Berka, , 99437

Berlin, Germany

Status

Recruiting

Address

Evang. Lungenklinik Berlin Klinik für Pneumologie

Berlin, , 13125

Gießen, Germany

Status

Active, not recruiting

Address

Klinik der Justus-Liebig-Universität; Innere Medizin

Gießen, , 35392

Thoraxklinik Heidelberg gGmbH, Heidelberg, Germany

Status

Active, not recruiting

Address

Thoraxklinik Heidelberg gGmbH

Heidelberg, , 69126

München, Germany

Status

Active, not recruiting

Address

Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

München, , 81377

Athens, Greece

Status

Active, not recruiting

Address

Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology

Athens, , 115 27

Chaidari, Greece

Status

Active, not recruiting

Address

University General Hospital of Athens "Attikon", B' University Pulmonary Clinic

Chaidari, , 124 62

Heraklio, Greece

Status

Active, not recruiting

Address

University General Hospital of Heraklio, Pulmonary Clinic

Heraklio, , 711 10

Mater Misericordiae University hospital, Dublin, Ireland

Status

Active, not recruiting

Address

Mater Misericordiae University hospital

Dublin, , 7

St Vincents University Hospital, Dublin, Ireland

Status

Active, not recruiting

Address

St Vincents University Hospital

Dublin, ,

Soroka; Pulmonary Clinic, Beer Sheba, Israel

Status

Active, not recruiting

Address

Soroka; Pulmonary Clinic

Beer Sheba, , 8410101

Haifa, Israel

Status

Active, not recruiting

Address

Carmel Medical Center; Pulmonary Institute

Haifa, , 3436212

Jerusalem, Israel

Status

Active, not recruiting

Address

Shaare Zedek Medical Center; Pulmonary Inst.

Jerusalem, , 9103102

Jerusalem, Israel

Status

Active, not recruiting

Address

Hadassah Medical Center; Pulmonary Institute

Jerusalem, , 9112001

Meir Medical Center; Pulmonary Dept, Kfar Saba, Israel

Status

Active, not recruiting

Address

Meir Medical Center; Pulmonary Dept

Kfar Saba, , 4428164

Petach Tikva, Israel

Status

Active, not recruiting

Address

Beilinson Medical Center; Pulmonary Inst.

Petach Tikva, , 4941492

Kaplan Medical Center, Rehovot, Israel

Status

Active, not recruiting

Address

Kaplan Medical Center

Rehovot, , 7661041

Forlì, Emilia-Romagna, Italy

Status

Active, not recruiting

Address

Ospedale Morgagni-Pierantoni; U.O. Pneumologia

Forlì, Emilia-Romagna, 47121

Roma, Lazio, Italy

Status

Active, not recruiting

Address

Policlinico A.Gemelli Università Cattolica del Sacro Cuore; Pneumologia

Roma, Lazio, 00165

Milano, Lombardia, Italy

Status

Active, not recruiting

Address

Ospedale San Giuseppe; U.O. di Pneumologia

Milano, Lombardia, 20123

Gdansk, Poland

Status

Active, not recruiting

Address

Uniwersyteckie Centrum Kliniczne;Klinika Alergologii i Pneumonologii

Gdansk, , 80-952

Torrette Di Ancona, Marche, Italy

Status

Active, not recruiting

Address

A.O.U. Ospedali Riuniti Umberto I -G.M. Lancisi-G. Salesi Ancona; SOD Pneumologia

Torrette Di Ancona, Marche, 60100

Orbassano (TO), Piemonte, Italy

Status

Active, not recruiting

Address

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

Orbassano (TO), Piemonte, 10043

Catania, Sicilia, Italy

Status

Active, not recruiting

Address

A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone

Catania, Sicilia, 95123

Palermo, Sicilia, Italy

Status

Terminated

Address

A.O. Ospedali Riuniti; Villa Sofia-Cervello di Palermo; U. O. Pneumologia 2 - Padiglione B

Palermo, Sicilia, 90146

Firenze, Toscana, Italy

Status

Active, not recruiting

Address

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

Firenze, Toscana, 50134

Lodz, Poland

Status

Active, not recruiting

Address

Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

Lodz, , 90-153

Warszawa, Poland

Status

Active, not recruiting

Address

Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc

Warszawa, , 01-138

Aveiro, Portugal

Status

Active, not recruiting

Address

Hospital Infante D. Pedro; Servico de Pneumologia

Aveiro, , 3814-501

HUC; Servico de Pneumologia A, Coimbra, Portugal

Status

Active, not recruiting

Address

HUC; Servico de Pneumologia A

Coimbra, , 3000-075

Lisboa, Portugal

Status

Withdrawn

Address

Hospital Pulido Valente; Servico de Pneumologia

Lisboa, , 1796-001

Porto, Portugal

Status

Active, not recruiting

Address

Hospital de Sao Joao; Servico de Pneumologia

Porto, , 4200

Vila Nova De Gaia, Portugal

Status

Active, not recruiting

Address

CHVNG/E_Unidade 1; Servico de Pneumologia

Vila Nova De Gaia, , 4434-502

Hospitalet de Llobregat, Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Universitari de Bellvitge ; Servicio de Neumologia

Hospitalet de Llobregat, Barcelona, 08097

Santander, Cantabria, Spain

Status

Active, not recruiting

Address

Hospital Universitario Marques de Valdecilla; Servicio de neumologia

Santander, Cantabria, 39008

Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario La Princesa; Servicio de Neumologia

Madrid, , 28006

Madrid, Spain

Status

Active, not recruiting

Address

Hospital Clínico San Carlos - Servicio de Neumologia

Madrid, , 28040

Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario 12 de Octubre; Servicio de Neumologia

Madrid, , 28041

Birmingham, United Kingdom

Status

Active, not recruiting

Address

University Hospital Birmingham Queen Elizabeth Hospital

Birmingham, , B15 2TH

Bristol, United Kingdom

Status

Active, not recruiting

Address

Southmead Hospital; Respiratory Department

Bristol, , BS10-5NB

Cambridge, United Kingdom

Status

Active, not recruiting

Address

Papworth Hospital NHS Foundation Trust; Respiratory Department

Cambridge, , CB23 3RE

Edinburgh, United Kingdom

Status

Active, not recruiting

Address

Edinburgh Royal Infirmary; Respiratory Department

Edinburgh, , EH16 4SA

Exeter, United Kingdom

Status

Active, not recruiting

Address

Royal Devon and Exeter Hospital (Wonford)

Exeter, , EX2 5DW

Glenfield Hospital, Leicester, United Kingdom

Status

Active, not recruiting

Address

Glenfield Hospital

Leicester, , LE3 9QP

London, United Kingdom

Status

Active, not recruiting

Address

University College London Hospital; Respiratory Medicine

London, , NW1 2BU

London, United Kingdom

Status

Active, not recruiting

Address

Royal Brompton Hospital; Respiratory Department

London, , SW3 6NP

Manchester, United Kingdom

Status

Active, not recruiting

Address

Wythenshawe Hospital; North West Lung Research Centre

Manchester, , M23 9LT

Northern General Hospital, Sheffield, United Kingdom

Status

Active, not recruiting

Address

Northern General Hospital

Sheffield, , S5 7AU

Southampton, United Kingdom

Status

Recruiting

Address

Southampton University Hospitals NHS Trust

Southampton, , SO16 6YD

Royal Stoke University Hospital, Stoke on Trent, United Kingdom

Status

Active, not recruiting

Address

Royal Stoke University Hospital

Stoke on Trent, , ST4 6QG