Clinical trial NCT02699879: Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official title: Post-Authorisation Safety Study of Esbriet® (Pirfenidone): A Prospective Observational Registry to Evaluate Long-Term Safety in a Real-World Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 1009
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving treatment for IPF with pirfenidone according to the physician's discretion

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of participants with clinically significant ADRs of special interest
timeFrame: up to 2 years
measure: Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz; Department for Respiratory Diseases
city: Hohenems
country: Austria
facility: LKH Hohenems; Abteilung für Pulmologie
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt; Abteilung für Pulmologie
city: Salzburg
country: Austria
facility: St. Johanns-Spital; Abt. Für Lungenkrankungen
city: Aarhus
country: Denmark
facility: Aarhus University Hospital; Lungemed afd. B
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Lungemedicinsk Afdeling
city: Odense
country: Denmark
facility: Odense Universitetshospital, Lungemedicinsk Afdeling J
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Dep. of Pulmonary Medicine
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital; Lung Clinic
city: Turku
country: Finland
facility: Turku University Hospital; Dept of Pulmonology
city: Angers
country: France
facility: CHU Angers,Service de Pneumologie
city: Besancon
country: France
facility: Hopital Jean Minjoz; Pneumologie
city: Bobigny
country: France
facility: Hopital Avicenne; Pneumologie
city: Brest
country: France
facility: Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie
city: Bron
country: France
facility: Hopital Louis Pradel; Pneumologie
city: Caen
country: France
facility: Hopital Cote De Nacre; Pneumologie
city: Dijon
country: France
facility: Chu Site Du Bocage;Pneumologie
city: Grenoble
country: France
facility: CHU de Grenoble; Medecine Aigue Spec
city: Lille
country: France
facility: Hopital Calmette; Pneumologie
city: Limoges
country: France
facility: CHU de Limoges
city: Marseille cedex 20
country: France
facility: Hopital Nord; Pneumologie
city: Marseille
country: France
facility: Hopital Nord AP-HM
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Bichat Claude Bernard ; Service de Pneumologie
city: Paris
country: France
facility: HEGP; Pneumologie
city: Paris
country: France
facility: Hopital Tenon;Pneumologie
city: Pessac
country: France
facility: Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud
city: Reims
country: France
facility: Hopital De La Maison Blanche;Maladies Respiratoires
city: Rennes
country: France
facility: Hopital de Pontchaillou; Service de Pneumologie
city: Strasbourg
country: France
facility: Chu De Strasbourg; Hopital Civil
city: Toulouse
country: France
facility: Hopital Larrey; Pneumologie
city: Tours
country: France
facility: Chu De Tours,Service de Pneumologie
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH; Pneumologie
city: Ballenstedt
country: Germany
facility: Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH
city: Berlin
country: Germany
facility: Evang. Lungenklinik Berlin Klinik für Pneumologie
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
city: Coburg
country: Germany
facility: Klinkum Coburg GmbH
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
city: Cottbus
country: Germany
facility: Carl-Thiem-Klinik Cottbus; Medizinische Klinik
city: Donaustauf
country: Germany
facility: Klinik Donaustauf Zentrum für Pneumologie
city: Essen
country: Germany
facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
city: Esslingen
country: Germany
facility: Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
city: Frankfurt am Main
country: Germany
facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
city: Frankfurt
country: Germany
facility: Klinik Maingau
city: Frankfurt
country: Germany
facility: Studienzentrum/Praxis Dr. Keller Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Abteilung Pneumologie
city: Gerlingen
country: Germany
facility: Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie
city: Gießen
country: Germany
facility: Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik
city: Großhansdorf
country: Germany
facility: LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hannover
country: Germany
facility: KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin
city: Hemer
country: Germany
facility: Lungenklinik Hemer; Abt. Pneumologie
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes; Innere Medizin V
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen
city: Jena
country: Germany
facility: Universitätsklinikum Jena; Medizinische Klinik I
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
city: Lostau
country: Germany
facility: Lungenklinik Lostau gGmbH; Klinik für Pneumologie II
city: Löwenstein
country: Germany
facility: Klinik Löwenstein gGmbH Medizinische Klinik II
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
city: München
country: Germany
facility: Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
city: Nürnberg
country: Germany
facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim, Medizinische Klinik III
city: Solingen
country: Germany
facility: Krankenhaus Bethanien gGmbH
city: Stuttgart
country: Germany
facility: Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie
city: Treuenbrietzen
country: Germany
facility: Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
city: Wangen
country: Germany
facility: Fachkliniken Wangen Medizinische Klinik
city: Wuerzburg
country: Germany
facility: Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin 4
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: Mater Misecordiae University Hospital
city: Galway
country: Ireland
facility: Galway University Hospital; Department of Respiratory Medicine
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni; U.O. Pneumologia
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
state: Emilia-Romagna
city: Monza
country: Italy
facility: Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart
state: Lombardia
city: Orbassano (TO)
country: Italy
facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
state: Piemonte
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica
state: Sardegna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Siena
country: Italy
facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
state: Toscana
city: Bergen
country: Norway
facility: Haukeland Hospital - University Of Bergen: Department of Resp Med
city: Oslo
country: Norway
facility: Oslo University Hospital Rikshospitalet; Lungeavdelingen
city: Trondheim
country: Norway
facility: St. Olav's Hospital; Lung Clinic
city: Stokholm, Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna; Lung Allergikliniken
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset; Lungmedicinska Kliniken
city: Bristol
country: United Kingdom
facility: Southmead Hospital; Respiratory Department
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust; Respiratory Department
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital; Respiratory Medicine
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Hampshire
country: United Kingdom
facility: Southampton General Hospital; Respiratory Department
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Liecester
country: United Kingdom
facility: University Hospital Aintree; Pulmonary Vascular Diseases Unit
city: London
country: United Kingdom
facility: University College London Hospital; Respiratory Medicine
city: London
country: United Kingdom
facility: Royal Brompton Hospital; Respiratory Department
city: London
country: United Kingdom
facility: St. Mary'S Hospital; Dept of Medicine
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals City Campus
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital; Respiratory Centre
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Staffordshire; ILD Clinic
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: