Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting
2 other identifiers
observational
1,009
10 countries
106
Brief Summary
This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2012
Longer than P75 for all trials
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2012
CompletedFirst Submitted
Initial submission to the registry
February 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2016
CompletedApril 21, 2017
April 1, 2017
4.6 years
February 26, 2016
April 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of participants with clinically significant ADRs of special interest
up to 2 years
Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions
up to 2 years
Study Arms (1)
Pirfenidone
Participants will receive pirfenidone orally according to the physician discretion.
Interventions
Pirfenidone will be administered according to the physician discretion as part of standard care.
Eligibility Criteria
Participants receiving treatment for IPF with pirfenidone according to the physician's discretion
You may qualify if:
- A clinical decision has been made, prior to study enrolment, to prescribe Esbriet
- Participants who are newly prescribed Esbriet therapy
- Initiation of Esbriet therapy is not more than 30 days prior to study enrolment
You may not qualify if:
- Participants receiving an investigational agent defined as any drug that has not been approved for marketing for any indication in the country of the participating site
- Participant has received Esbriet therapy 30 days or more prior to current treatment course (e.g., prior participation in clinical trials)
- Participant has any contraindication for the use of Esbriet, according to the current local version of the Summary of Product Characteristics (SPC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (106)
Medical University Graz; Department for Respiratory Diseases
Graz, 8036, Austria
LKH Hohenems; Abteilung für Pulmologie
Hohenems, 6845, Austria
Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre
Innsbruck, 6020, Austria
Klinikum Klagenfurt; Abteilung für Pulmologie
Klagenfurt, 9020, Austria
St. Johanns-Spital; Abt. Für Lungenkrankungen
Salzburg, 5020, Austria
Aarhus University Hospital; Lungemed afd. B
Aarhus, 8000, Denmark
Gentofte Hospital, Lungemedicinsk Afdeling
Hellerup, 2900, Denmark
Odense Universitetshospital, Lungemedicinsk Afdeling J
Odense, 5000, Denmark
Helsinki University Central Hospital; Dep. of Pulmonary Medicine
Helsinki, 00290, Finland
Kuopio University Hospital
Kuopio, 70211, Finland
Tampere University Hospital; Lung Clinic
Tampere, 33521, Finland
Turku University Hospital; Dept of Pulmonology
Turku, 20521, Finland
CHU Angers,Service de Pneumologie
Angers, 49933, France
Hopital Jean Minjoz; Pneumologie
Besançon, 25030, France
Hopital Avicenne; Pneumologie
Bobigny, 93000, France
Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie
Brest, 29609, France
Hopital Louis Pradel; Pneumologie
Bron, 69677, France
Hopital Cote De Nacre; Pneumologie
Caen, 14033, France
Chu Site Du Bocage;Pneumologie
Dijon, 21079, France
CHU de Grenoble; Medecine Aigue Spec
Grenoble, 38043, France
Hopital Calmette; Pneumologie
Lille, 59037, France
CHU de Limoges
Limoges, 87042, France
Hopital Nord AP-HM
Marseille, 13015, France
Hopital Nord; Pneumologie
Marseille, 13915, France
CHU Montpellier
Montpellier, 34295, France
Hopital Saint Louis
Paris, 75475, France
Hopital Bichat Claude Bernard ; Service de Pneumologie
Paris, 75877, France
HEGP; Pneumologie
Paris, 75908, France
Hopital Tenon;Pneumologie
Paris, 75970, France
Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud
Pessac, 33604, France
Hopital De La Maison Blanche;Maladies Respiratoires
Reims, 51092, France
Hopital de Pontchaillou; Service de Pneumologie
Rennes, 35033, France
Chu De Strasbourg; Hopital Civil
Strasbourg, 67091, France
Hopital Larrey; Pneumologie
Toulouse, 31059, France
Chu De Tours,Service de Pneumologie
Tours, 37000, France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, 99437, Germany
Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH
Ballenstedt, 06493, Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, 13125, Germany
Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo
Berlin, 13353, Germany
Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie
Berlin, 14089, Germany
HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
Berlin, 14165, Germany
Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
Bochum, 44789, Germany
Klinkum Coburg GmbH
Coburg, 96450, Germany
Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
Coswig, 01640, Germany
Carl-Thiem-Klinik Cottbus; Medizinische Klinik
Cottbus, 03048, Germany
Klinik Donaustauf Zentrum für Pneumologie
Donaustauf, 93093, Germany
Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
Essen, 45239, Germany
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
Esslingen am Neckar, 73730, Germany
Klinik Maingau
Frankfurt, 60318, Germany
Studienzentrum/Praxis Dr. Keller Frankfurt
Frankfurt, 60389, Germany
IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
Frankfurt am Main, 60596, Germany
Universitätsklinikum Freiburg, Abteilung Pneumologie
Freiburg im Breisgau, 79106, Germany
Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie
Gerlingen, 70839, Germany
Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
Giessen, 35392, Germany
Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik
Greifswald, 17489, Germany
LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie
Großhansdorf, 22927, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin
Hanover, 30659, Germany
Lungenklinik Hemer; Abt. Pneumologie
Hemer, 58675, Germany
Universitaetsklinikum des Saarlandes; Innere Medizin V
Homburg/Saar, 66421, Germany
Fachklinik für Lungenerkrankungen
Immenhausen, 34376, Germany
Universitätsklinikum Jena; Medizinische Klinik I
Jena, 07747, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24116, Germany
Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
Leipzig, 04103, Germany
Lungenklinik Lostau gGmbH; Klinik für Pneumologie II
Lostau, 39291, Germany
Klinik Löwenstein gGmbH Medizinische Klinik II
Löwenstein, 74245, Germany
Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
Magdeburg, 39120, Germany
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
München, 81377, Germany
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nuremberg, 90419, Germany
RoMed Klinikum Rosenheim, Medizinische Klinik III
Rosenheim, 83022, Germany
Krankenhaus Bethanien gGmbH
Solingen, 42699, Germany
Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie
Stuttgart, 70372, Germany
Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
Treuenbrietzen, 14929, Germany
Fachkliniken Wangen Medizinische Klinik
Wangen, 88239, Germany
Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik
Würzburg, 97080, Germany
Cork University Hospital
Cork, Ireland
Mater Misecordiae University Hospital
Dublin, 7, Ireland
St Vincents University Hospital
Dublin, Ireland
Galway University Hospital; Department of Respiratory Medicine
Galway, Ireland
Ospedale Morgagni-Pierantoni; U.O. Pneumologia
Forlì, Emilia-Romagna, 47121, Italy
A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
Modena, Emilia-Romagna, 41124, Italy
Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart
Monza, Lombardy, 20052, Italy
A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
Orbassano (TO), Piedmont, 10043, Italy
Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica
Sassari, Sardinia, 07100, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50141, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
Siena, Tuscany, 53100, Italy
Haukeland Hospital - University Of Bergen: Department of Resp Med
Bergen, 5021, Norway
Oslo University Hospital Rikshospitalet; Lungeavdelingen
Oslo, 0424, Norway
St. Olav's Hospital; Lung Clinic
Trondheim, 7006, Norway
Karolinska Universitetssjukhuset Solna; Lung Allergikliniken
Stokholm, Solna, 17176, Sweden
Akademiska Sjukhuset; Lungmedicinska Kliniken
Uppsala, 751 85, Sweden
Southmead Hospital; Respiratory Department
Bristol, BS10-5NB, United Kingdom
Papworth Hospital NHS Foundation Trust; Respiratory Department
Cambridge, CB23 3RE, United Kingdom
Castle Hill Hospital; Respiratory Medicine
Cottingham, HU16 5JQ, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
Southampton General Hospital; Respiratory Department
Hampshire, SO16 6YD, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
University Hospital Aintree; Pulmonary Vascular Diseases Unit
Liecester, L9 7AL, United Kingdom
University College London Hospital; Respiratory Medicine
London, NW1 2BU, United Kingdom
Royal Brompton Hospital; Respiratory Department
London, SW3 6NP, United Kingdom
St. Mary'S Hospital; Dept of Medicine
London, W2 1NY, United Kingdom
Wythenshawe Hospital
Manchester, M23 9QZ, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB, United Kingdom
Queen Alexandra Hospital; Respiratory Centre
Portsmouth, PO6 3LY, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
University Hospital of North Staffordshire; ILD Clinic
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (1)
Behr J, Nathan SD, Costabel U, Albera C, Wuyts WA, Glassberg MK, Haller H Jr, Alvaro G, Gilberg F, Samara K, Lancaster L. Efficacy and Safety of Pirfenidone in Advanced Versus Non-Advanced Idiopathic Pulmonary Fibrosis: Post-Hoc Analysis of Six Clinical Studies. Adv Ther. 2023 Sep;40(9):3937-3955. doi: 10.1007/s12325-023-02565-3. Epub 2023 Jun 30.
PMID: 37391667DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 4, 2016
Study Start
February 16, 2012
Primary Completion
September 15, 2016
Study Completion
September 15, 2016
Last Updated
April 21, 2017
Record last verified: 2017-04