Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699879
• Other study ID #: WB29908
• Secondary ID: PIPF-025
• Status: Completed
• Phase: N/A
• First received: February 26, 2016
• Last updated: April 20, 2017
• Start date: February 16, 2012
• Est. completion date: September 15, 2016

Study information

• Verified date: April 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1009
• Est. completion date: September 15, 2016
• Est. primary completion date: September 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Pirfenidone
Pirfenidone will be administered according to the physician discretion as part of standard care.

Locations

Country	Name	City	State
Austria	Medical University Graz; Department for Respiratory Diseases	Graz
Austria	LKH Hohenems; Abteilung für Pulmologie	Hohenems
Austria	Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre	Innsbruck
Austria	Klinikum Klagenfurt; Abteilung für Pulmologie	Klagenfurt
Austria	St. Johanns-Spital; Abt. Für Lungenkrankungen	Salzburg
Denmark	Aarhus University Hospital; Lungemed afd. B	Aarhus
Denmark	Gentofte Hospital, Lungemedicinsk Afdeling	Hellerup
Denmark	Odense Universitetshospital, Lungemedicinsk Afdeling J	Odense
Finland	Helsinki University Central Hospital; Dep. of Pulmonary Medicine	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Tampere University Hospital; Lung Clinic	Tampere
Finland	Turku University Hospital; Dept of Pulmonology	Turku
France	CHU Angers,Service de Pneumologie	Angers
France	Hopital Jean Minjoz; Pneumologie	Besancon
France	Hopital Avicenne; Pneumologie	Bobigny
France	Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie	Brest
France	Hopital Louis Pradel; Pneumologie	Bron
France	Hopital Cote De Nacre; Pneumologie	Caen
France	Chu Site Du Bocage;Pneumologie	Dijon
France	CHU de Grenoble; Medecine Aigue Spec	Grenoble
France	Hopital Calmette; Pneumologie	Lille
France	CHU de Limoges	Limoges
France	Hopital Nord AP-HM	Marseille
France	Hopital Nord; Pneumologie	Marseille cedex 20
France	CHU Montpellier	Montpellier
France	HEGP; Pneumologie	Paris
France	Hopital Bichat Claude Bernard ; Service de Pneumologie	Paris
France	Hopital Saint Louis	Paris
France	Hopital Tenon;Pneumologie	Paris
France	Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud	Pessac
France	Hopital De La Maison Blanche;Maladies Respiratoires	Reims
France	Hopital de Pontchaillou; Service de Pneumologie	Rennes
France	Chu De Strasbourg; Hopital Civil	Strasbourg
France	Hopital Larrey; Pneumologie	Toulouse
France	Chu De Tours,Service de Pneumologie	Tours
Germany	Zentralklinik Bad Berka GmbH; Pneumologie	Bad Berka
Germany	Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH	Ballenstedt
Germany	Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo	Berlin
Germany	Evang. Lungenklinik Berlin Klinik für Pneumologie	Berlin
Germany	Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie	Berlin
Germany	HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie	Berlin
Germany	Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH	Bochum
Germany	Klinkum Coburg GmbH	Coburg
Germany	Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie	Coswig
Germany	Carl-Thiem-Klinik Cottbus; Medizinische Klinik	Cottbus
Germany	Klinik Donaustauf Zentrum für Pneumologie	Donaustauf
Germany	Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie	Essen
Germany	Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie	Esslingen
Germany	Klinik Maingau	Frankfurt
Germany	Studienzentrum/Praxis Dr. Keller Frankfurt	Frankfurt
Germany	IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie	Frankfurt am Main
Germany	Universitätsklinikum Freiburg, Abteilung Pneumologie	Freiburg
Germany	Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie	Gerlingen
Germany	Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie	Gießen
Germany	Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik	Greifswald
Germany	LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie	Großhansdorf
Germany	KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin	Hannover
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Lungenklinik Hemer; Abt. Pneumologie	Hemer
Germany	Universitaetsklinikum des Saarlandes; Innere Medizin V	Homburg/Saar
Germany	Fachklinik für Lungenerkrankungen	Immenhausen
Germany	Universitätsklinikum Jena; Medizinische Klinik I	Jena
Germany	Universitaetsklinikum Schleswig-Holstein, Campus Kiel	Kiel
Germany	Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie	Leipzig
Germany	Lungenklinik Lostau gGmbH; Klinik für Pneumologie II	Lostau
Germany	Klinik Löwenstein gGmbH Medizinische Klinik II	Löwenstein
Germany	Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie	Magdeburg
Germany	Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V	München
Germany	Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin	Nürnberg
Germany	RoMed Klinikum Rosenheim, Medizinische Klinik III	Rosenheim
Germany	Krankenhaus Bethanien gGmbH	Solingen
Germany	Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie	Stuttgart
Germany	Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie	Treuenbrietzen
Germany	Fachkliniken Wangen Medizinische Klinik	Wangen
Germany	Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik	Wuerzburg
Ireland	Cork University Hospital	Cork
Ireland	Mater Misecordiae University Hospital	Dublin
Ireland	St Vincents University Hospital	Dublin 4
Ireland	Galway University Hospital; Department of Respiratory Medicine	Galway
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	Toscana
Italy	Ospedale Morgagni-Pierantoni; U.O. Pneumologia	Forlì	Emilia-Romagna
Italy	A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio	Modena	Emilia-Romagna
Italy	Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart	Monza	Lombardia
Italy	A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone	Orbassano (TO)	Piemonte
Italy	Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica	Sassari	Sardegna
Italy	A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare	Siena	Toscana
Norway	Haukeland Hospital - University Of Bergen: Department of Resp Med	Bergen
Norway	Oslo University Hospital Rikshospitalet; Lungeavdelingen	Oslo
Norway	St. Olav's Hospital; Lung Clinic	Trondheim
Sweden	Karolinska Universitetssjukhuset Solna; Lung Allergikliniken	Stokholm, Solna
Sweden	Akademiska Sjukhuset; Lungmedicinska Kliniken	Uppsala
United Kingdom	Southmead Hospital; Respiratory Department	Bristol
United Kingdom	Papworth Hospital NHS Foundation Trust; Respiratory Department	Cambridge
United Kingdom	Castle Hill Hospital; Respiratory Medicine	Cottingham
United Kingdom	Royal Devon and Exeter Hospital (Wonford)	Exeter
United Kingdom	Southampton General Hospital; Respiratory Department	Hampshire
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	University Hospital Aintree; Pulmonary Vascular Diseases Unit	Liecester
United Kingdom	Royal Brompton Hospital; Respiratory Department	London
United Kingdom	St. Mary'S Hospital; Dept of Medicine	London
United Kingdom	University College London Hospital; Respiratory Medicine	London
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Nottingham University Hospitals City Campus	Nottingham
United Kingdom	Queen Alexandra Hospital; Respiratory Centre	Portsmouth
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	University Hospital of North Staffordshire; ILD Clinic	Stoke-on-Trent

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Denmark,  Finland,  France,  Germany,  Ireland,  Italy,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with clinically significant ADRs of special interest		up to 2 years
Primary	Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions		up to 2 years