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| ID | Type | Description | Link |
|---|---|---|---|
| PIPF-025 | Other Identifier | InterMune |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone | Participants will receive pirfenidone orally according to the physician discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | Pirfenidone will be administered according to the physician discretion as part of standard care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants receiving treatment for IPF with pirfenidone according to the physician's discretion
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz; Department for Respiratory Diseases | Graz | 8036 | Austria | |||
| LKH Hohenems; Abteilung für Pulmologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37391667 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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