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Idiopathic Pulmonary FibrosisNCT02699879

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

An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 106 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Pirfenidone
Type of treatment
Pill or oral medicine
How many people
1,009 participants
Where
106 sitesin 10 countries
Study dates
16 Feb 2012to 15 Sep 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

106 sites in 10 countries.

106 sites in 10 countries

Germany40 sites

  • Zentralklinik Bad Berka GmbH; Pneumologie

    Bad Berka, 99437

  • Lungenklinik Ballenstedt/Harz gGmbH Lungenklinik Ballenstedt/Harz gGmbH

    Ballenstedt, 06493

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125

  • Charite - Universitätsmedizin Berlin; Campus Virchow-Klinikum, Med. Klinik m. S. Infekt und Pneumo

    Berlin, 13353

  • Gemeinschaftskrankenhaus Havelhöhe Klinik f.Innere Medizin Kardiologie Pneumologie

    Berlin, 14089

  • HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie

    Berlin, 14165

  • Berufsgenossenschaftliches Uni-Klinikum Bergmannsheil GmbH

    Bochum, 44789

  • Klinkum Coburg GmbH

    Coburg, 96450

  • Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie

    Coswig, 01640

  • Carl-Thiem-Klinik Cottbus; Medizinische Klinik

    Cottbus, 03048

  • Klinik Donaustauf Zentrum für Pneumologie

    Donaustauf, 93093

  • Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

    Essen, 45239

  • Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie

    Esslingen am Neckar, 73730

  • Klinik Maingau

    Frankfurt, 60318

  • Studienzentrum/Praxis Dr. Keller Frankfurt

    Frankfurt, 60389

  • IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

    Frankfurt am Main, 60596

  • Universitätsklinikum Freiburg, Abteilung Pneumologie

    Freiburg im Breisgau, 79106

  • Klinik Schillerhöhe Zentrum f.Pneumologie u.Thoraxchirurgie

    Gerlingen, 70839

  • Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie

    Giessen, 35392

  • Universitätsmedizin Greifswald Klinik für Innere Medizin B und Poliklinik

    Greifswald, 17489

  • LungenClinic Grosshansdorf GmbH; Zentrum fur Pneumologie und Thoraxchirurgie

    Großhansdorf, 22927

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • KRH Klinikum Oststadt-Heidehaus; Pneumologie, Intensiv- und Schlafmedizin

    Hanover, 30659

  • Lungenklinik Hemer; Abt. Pneumologie

    Hemer, 58675

  • Universitaetsklinikum des Saarlandes; Innere Medizin V

    Homburg/Saar, 66421

  • Fachklinik für Lungenerkrankungen

    Immenhausen, 34376

  • Universitätsklinikum Jena; Medizinische Klinik I

    Jena, 07747

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24116

  • Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

    Leipzig, 04103

  • Lungenklinik Lostau gGmbH; Klinik für Pneumologie II

    Lostau, 39291

  • Klinik Löwenstein gGmbH Medizinische Klinik II

    Löwenstein, 74245

  • Universitätsklinikum Magdeburg Klinik für Kardiologie Angiologie u.Pneumologie

    Magdeburg, 39120

  • Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V

    München, 81377

  • Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

    Nuremberg, 90419

  • RoMed Klinikum Rosenheim, Medizinische Klinik III

    Rosenheim, 83022

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699

  • Krankenhaus vom Roten Kreutz; Klinik fuer Pneumologie

    Stuttgart, 70372

  • Johanniter-Krankenhaus im Fläming Treuenbrietzen GmbH; Fachklinik Pneumologie/ Thoraxchirurgie

    Treuenbrietzen, 14929

  • Fachkliniken Wangen Medizinische Klinik

    Wangen, 88239

  • Universitätsklinikum Würzburg, Kinderklinik u. Poliklinik

    Würzburg, 97080

Other trials in Germany

France23 sites

  • CHU Angers,Service de Pneumologie

    Angers, 49933

  • Hopital Jean Minjoz; Pneumologie

    Besançon, 25030

  • Hopital Avicenne; Pneumologie

    Bobigny, 93000

  • Hopital de La Cavale Blanche; Service de Medecine Interne & de Pneumologie

    Brest, 29609

  • Hopital Louis Pradel; Pneumologie

    Bron, 69677

  • Hopital Cote De Nacre; Pneumologie

    Caen, 14033

  • Chu Site Du Bocage;Pneumologie

    Dijon, 21079

  • CHU de Grenoble; Medecine Aigue Spec

    Grenoble, 38043

  • Hopital Calmette; Pneumologie

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Hopital Nord AP-HM

    Marseille, 13015

  • Hopital Nord; Pneumologie

    Marseille, 13915

  • CHU Montpellier

    Montpellier, 34295

  • Hopital Saint Louis

    Paris, 75475

  • Hopital Bichat Claude Bernard ; Service de Pneumologie

    Paris, 75877

  • HEGP; Pneumologie

    Paris, 75908

  • Hopital Tenon;Pneumologie

    Paris, 75970

  • Hôpital Haut-Lévêque - CHU de Bordeaux - Groupe Hospitalier Sud

    Pessac, 33604

  • Hopital De La Maison Blanche;Maladies Respiratoires

    Reims, 51092

  • Hopital de Pontchaillou; Service de Pneumologie

    Rennes, 35033

  • Chu De Strasbourg; Hopital Civil

    Strasbourg, 67091

  • Hopital Larrey; Pneumologie

    Toulouse, 31059

  • Chu De Tours,Service de Pneumologie

    Tours, 37000

Other trials in France

United Kingdom15 sites

  • Southmead Hospital; Respiratory Department

    Bristol, BS10-5NB

  • Papworth Hospital NHS Foundation Trust; Respiratory Department

    Cambridge, CB23 3RE

  • Castle Hill Hospital; Respiratory Medicine

    Cottingham, HU16 5JQ

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Southampton General Hospital; Respiratory Department

    Hampshire, SO16 6YD

  • Glenfield Hospital

    Leicester, LE3 9QP

  • University Hospital Aintree; Pulmonary Vascular Diseases Unit

    Liecester, L9 7AL

  • University College London Hospital; Respiratory Medicine

    London, NW1 2BU

  • Royal Brompton Hospital; Respiratory Department

    London, SW3 6NP

  • St. Mary'S Hospital; Dept of Medicine

    London, W2 1NY

  • Wythenshawe Hospital

    Manchester, M23 9QZ

  • Nottingham University Hospitals City Campus

    Nottingham, NG5 1PB

  • Queen Alexandra Hospital; Respiratory Centre

    Portsmouth, PO6 3LY

  • Northern General Hospital

    Sheffield, S5 7AU

  • University Hospital of North Staffordshire; ILD Clinic

    Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Italy7 sites

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50141

  • Ospedale Morgagni-Pierantoni; U.O. Pneumologia

    Forlì, Emilia-Romagna, 47121

  • A.O. Universitaria Policlinico Di Modena; DIP. Malattie Dell'apparato Respiratorio

    Modena, Emilia-Romagna, 41124

  • Universita' Degli Studi Di Milano Bicocca, Ospedale Vecchio; facolta di medicina e chirurgia, dipart

    Monza, Lombardy, 20052

  • A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

    Orbassano (TO), Piedmont, 10043

  • Azienda Ospedaliero Universitaria Di Sassari; Clinica Pneumologica

    Sassari, Sardinia, 07100

  • A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare

    Siena, Tuscany, 53100

Other trials in Italy

Austria5 sites

  • Medical University Graz; Department for Respiratory Diseases

    Graz, 8036

  • LKH Hohenems; Abteilung für Pulmologie

    Hohenems, 6845

  • Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre

    Innsbruck, 6020

  • Klinikum Klagenfurt; Abteilung für Pulmologie

    Klagenfurt, 9020

  • St. Johanns-Spital; Abt. Für Lungenkrankungen

    Salzburg, 5020

Other trials in Austria

Finland4 sites

  • Helsinki University Central Hospital; Dep. of Pulmonary Medicine

    Helsinki, 00290

  • Kuopio University Hospital

    Kuopio, 70211

  • Tampere University Hospital; Lung Clinic

    Tampere, 33521

  • Turku University Hospital; Dept of Pulmonology

    Turku, 20521

Other trials in Finland

Ireland4 sites

  • Cork University Hospital

    Cork

  • Mater Misecordiae University Hospital

    Dublin, 7

  • St Vincents University Hospital

    Dublin

  • Galway University Hospital; Department of Respiratory Medicine

    Galway

Other trials in Ireland

Denmark3 sites

  • Aarhus University Hospital; Lungemed afd. B

    Aarhus, 8000

  • Gentofte Hospital, Lungemedicinsk Afdeling

    Hellerup, 2900

  • Odense Universitetshospital, Lungemedicinsk Afdeling J

    Odense, 5000

Other trials in Denmark

Norway3 sites

  • Haukeland Hospital - University Of Bergen: Department of Resp Med

    Bergen, 5021

  • Oslo University Hospital Rikshospitalet; Lungeavdelingen

    Oslo, 0424

  • St. Olav's Hospital; Lung Clinic

    Trondheim, 7006

Other trials in Norway

Sweden2 sites

  • Karolinska Universitetssjukhuset Solna; Lung Allergikliniken

    Stokholm, Solna, 17176

  • Akademiska Sjukhuset; Lungmedicinska Kliniken

    Uppsala, 751 85

Other trials in Sweden

About this study

Official title: 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.

Being tested
Pirfenidone
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PirfenidoneDrug

    Also called Esbriet

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

Study groups in NCT02699879
Study groupRoleWhat they receive
PirfenidoneParticipants will receive pirfenidone orally according to the physician discretion.
Receives: Drug: Pirfenidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with clinically significant ADRs of special interest

    Measured: up to 2 years

  2. Percentage of participants with adverse drug reactions (ADRs) and serious adverse drug reactions

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study start16 Feb 2012
  3. Primary completion15 Sep 2016
  4. Study completion15 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,009 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699879
Sponsor's protocol ID
WB29908
Other IDs
PIPF-025
Status last verified
Apr 2017
First submitted
26 Feb 2016
Last updated
21 Apr 2017
Results posted
No

Publications

  • 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.

    PubMed 37391667

Questions about this trial

What is this clinical trial studying?

An observational study of Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 106 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in Germany, France, United Kingdom, Italy, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with clinically significant ADRs of special interest (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02699879, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.

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