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

April 20, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1009

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University Graz; Department for Respiratory Diseases
      • Hohenems, Austria, 6845
        • LKH Hohenems; Abteilung für Pulmologie
      • Innsbruck, Austria, 6020
        • Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre
      • Klagenfurt, Austria, 9020
        • Klinikum Klagenfurt; Abteilung für Pulmologie
      • Salzburg, Austria, 5020
        • St. Johanns-Spital; Abt. Für Lungenkrankungen
  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital; Lungemed afd. B
      • Hellerup, Denmark, 2900
        • Gentofte Hospital, Lungemedicinsk Afdeling
      • Odense, Denmark, 5000
        • Odense Universitetshospital, Lungemedicinsk Afdeling J
  • Finland
      • Helsinki, Finland, 00290
        • Helsinki University Central Hospital; Dep. of Pulmonary Medicine
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
      • Tampere, Finland, 33521
        • Tampere University Hospital; Lung Clinic
      • Turku, Finland, 20521
        • Turku University Hospital; Dept of Pulmonology
  • France
      • Angers, France, 49933
        • CHU Angers,Service de Pneumologie
      • Besancon, France, 25030
        • Hopital Jean Minjoz; Pneumologie
      • Bobigny, France, 93000
        • Hopital Avicenne; Pneumologie
      • Brest, France, 29609
        • Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie
      • Bron, France, 69677
        • Hopital Louis Pradel; Pneumologie
      • Caen, France, 14033
        • Hopital Cote De Nacre; Pneumologie
      • Dijon, France, 21079
        • Chu Site Du Bocage;Pneumologie
      • Grenoble, France, 38043
        • CHU de Grenoble; Medecine Aigue Spec
      • Lille, France, 59037
        • Hopital Calmette; Pneumologie
      • Limoges, France, 87042
        • CHU de Limoges
      • Marseille, France, 13015
        • Hopital Nord AP-HM
      • Marseille cedex 20, France, 13915
        • Hopital Nord; Pneumologie
      • Montpellier, France, 34295
        • CHU Montpellier
      • Paris, France, 75475
        • Hopital Saint Louis
      • Paris, France, 75877
        • Hopital Bichat Claude Bernard ; Service de Pneumologie
      • Paris, France, 75908
        • HEGP; Pneumologie
      • Paris, France, 75970
        • Hopital Tenon;Pneumologie
      • Pessac, France, 33604
        • Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud
      • Reims, France, 51092
        • Hopital De La Maison Blanche;Maladies Respiratoires
      • Rennes, France, 35033
        • Hopital de Pontchaillou; Service de Pneumologie
      • Strasbourg, France, 67091
        • Chu De Strasbourg; Hopital Civil
      • Toulouse, France, 31059
        • Hopital Larrey; Pneumologie
      • Tours, France, 37000
        • Chu De Tours,Service de Pneumologie
  • Germany
      • Bad Berka, Germany, 99437
        • Zentralklinik Bad Berka GmbH; Pneumologie
      • Ballenstedt, Germany, 06493
        • Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH
      • Berlin, Germany, 13125
        • Evang. Lungenklinik Berlin Klinik für Pneumologie
      • Berlin, Germany, 13353
        • Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo
      • Berlin, Germany, 14089
        • Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie
      • Berlin, Germany, 14165
        • HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie
      • Bochum, Germany, 44789
        • Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH
      • Coburg, Germany, 96450
        • Klinkum Coburg GmbH
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie
      • Cottbus, Germany, 03048
        • Carl-Thiem-Klinik Cottbus; Medizinische Klinik
      • Donaustauf, Germany, 93093
        • Klinik Donaustauf Zentrum für Pneumologie
      • Essen, Germany, 45239
        • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie
      • Esslingen, Germany, 73730
        • Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
      • Frankfurt, Germany, 60318
        • Klinik Maingau
      • Frankfurt, Germany, 60389
        • Studienzentrum/Praxis Dr. Keller Frankfurt
      • Frankfurt am Main, Germany, 60596
        • IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg, Abteilung Pneumologie
      • Gerlingen, Germany, 70839
        • Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie
      • Gießen, Germany, 35392
        • Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie
      • Greifswald, Germany, 17489
        • Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik
      • Großhansdorf, Germany, 22927
        • LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Hannover, Germany, 30659
        • KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin
      • Hemer, Germany, 58675
        • Lungenklinik Hemer; Abt. Pneumologie
      • Homburg/Saar, Germany, 66421
        • Universitaetsklinikum des Saarlandes; Innere Medizin V
      • Immenhausen, Germany, 34376
        • Fachklinik für Lungenerkrankungen
      • Jena, Germany, 07747
        • Universitätsklinikum Jena; Medizinische Klinik I
      • Kiel, Germany, 24116
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
      • Leipzig, Germany, 04103
        • Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie
      • Lostau, Germany, 39291
        • Lungenklinik Lostau gGmbH; Klinik für Pneumologie II
      • Löwenstein, Germany, 74245
        • Klinik Löwenstein gGmbH Medizinische Klinik II
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie
      • München, Germany, 81377
        • Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
      • Nürnberg, Germany, 90419
        • Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
      • Rosenheim, Germany, 83022
        • RoMed Klinikum Rosenheim, Medizinische Klinik III
      • Solingen, Germany, 42699
        • Krankenhaus Bethanien gGmbH
      • Stuttgart, Germany, 70372
        • Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie
      • Treuenbrietzen, Germany, 14929
        • Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie
      • Wangen, Germany, 88239
        • Fachkliniken Wangen Medizinische Klinik
      • Wuerzburg, Germany, 97080
        • Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik
  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland, 7
        • Mater Misecordiae University Hospital
      • Dublin 4, Ireland
        • St Vincents University Hospital
      • Galway, Ireland
        • Galway University Hospital; Department of Respiratory Medicine
  • Italy
    • Emilia-Romagna
      • Forlì, Emilia-Romagna, Italy, 47121
        • Ospedale Morgagni-Pierantoni; U.O. Pneumologia
      • Modena, Emilia-Romagna, Italy, 41124
        • A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio
    • Lombardia
      • Monza, Lombardia, Italy, 20052
        • Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart
    • Piemonte
      • Orbassano (TO), Piemonte, Italy, 10043
        • A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica
    • Toscana
      • Firenze, Toscana, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Siena, Toscana, Italy, 53100
        • A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare
  • Norway
      • Bergen, Norway, 5021
        • Haukeland Hospital - University Of Bergen: Department of Resp Med
      • Oslo, Norway, 0424
        • Oslo University Hospital Rikshospitalet; Lungeavdelingen
      • Trondheim, Norway, 7006
        • St. Olav's Hospital; Lung Clinic
  • Sweden
      • Stokholm, Solna, Sweden, 17176
        • Karolinska Universitetssjukhuset Solna; Lung Allergikliniken
      • Uppsala, Sweden, 751 85
        • Akademiska Sjukhuset; Lungmedicinska Kliniken
  • United Kingdom
      • Bristol, United Kingdom, BS10-5NB
        • Southmead Hospital; Respiratory Department
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital NHS Foundation Trust; Respiratory Department
      • Cottingham, United Kingdom, HU16 5JQ
        • Castle Hill Hospital; Respiratory Medicine
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital (Wonford)
      • Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital; Respiratory Department
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • Liecester, United Kingdom, L9 7AL
        • University Hospital Aintree; Pulmonary Vascular Diseases Unit
      • London, United Kingdom, NW1 2BU
        • University College London Hospital; Respiratory Medicine
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital; Respiratory Department
      • London, United Kingdom, W2 1NY
        • St. Mary'S Hospital; Dept of Medicine
      • Manchester, United Kingdom, M23 9QZ
        • Wythenshawe Hospital
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals City Campus
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital; Respiratory Centre
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire; ILD Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants receiving treatment for IPF with pirfenidone according to the physician's discretion

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pirfenidone
Participants will receive pirfenidone orally according to the physician discretion.
Drug: Pirfenidone
Pirfenidone will be administered according to the physician discretion as part of standard care.
Other Names:
  • Esbriet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with clinically significant ADRs of special interest
Time Frame: up to 2 years
up to 2 years
Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2012

Primary Completion (Actual)

September 15, 2016

Study Completion (Actual)

September 15, 2016

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WB29908
  • PIPF-025 (Other Identifier: InterMune)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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