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Idiopathic Pulmonary FibrosisPhase 3NCT01619085

Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

A Phase 3 study testing Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 173 sites in 24 countries.

Completed

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

Official record
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Trial summary

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Nintedanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
752 participants
Where
173 sitesin 24 countries
Study dates
6 Jun 2012to 1 Feb 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
  • Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

Who cannot join

  • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper Limit of Normal (ULN) (Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible)
  • Bilirubin > 1.5 fold ULN
  • Bleeding risk
  • Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
  • New major thrombo-embolic events developed after completion of the parent trial.
  • Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
Show all 10Show fewer
  • Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial.
  • A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial.
  • Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
  • Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment.

Trial locations and contacts

173 sites in 24 countries.

173 sites in 24 countries

United States37 sites

  • Pulmonary and Critical Care Associates

    Albany, New York, 12205

  • Georgia Clinical Research

    Austell, Georgia, 30106

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0565

  • Vermont Lung Center

    Colchester, Vermont, 05446

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75235-8550

  • Western Connecticut Medical Group

    Danbury, Connecticut, 06810

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Jamaica Hospital Medical Center

    Jamaica, New York, 11418

  • Jasper Summit Research, LLC

    Jasper, Alabama, 35501

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • University of California

    Los Angeles, California, 90095-1690

  • Lynchburg Pulmonary Associates

    Lynchburg, Virginia, 24501

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Metroplex Pul and Sleep Ctr

    McKinney, Texas, 75069-1769

  • Minnesota Lung Center

    Minneapolis, Minnesota, 55407

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-5735

  • New York Presbyterian Hospital

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Pulmonary Associates

    Phoenix, Arizona, 85006

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • University of California

    San Francisco, California, 94143

  • Sansum Clinic

    Santa Barbara, California, 93105

  • FDC Seifer PLC Pulmonary

    Shelbyville, Tennessee, 37160

  • Pulmonary Assoc of Stamford

    Stamford, Connecticut, 06902

  • Stanford University Medical Center

    Stanford, California, 94305

  • ID Clinical Research, LTD

    Toledo, Ohio, 43608

  • University of California

    Torrance, California, 90505

  • Cleveland Clinic

    Weston, Florida, 33331

  • Via Christi Clinic, PA

    Wichita, Kansas, 67208

Other trials in United States

Japan25 sites

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560

  • Tosei General Hospital

    Aichi, Seto, 489-8642

  • Ogaki Municipal Hospital

    Gifu, Ogaki, 503-0864

  • National Hospital Organization Himeji Medical Center

    Himeji, Hyogo, 670-8520

  • Kobe City Medical Center General Hospital

    Hyogo, Kobe, 650-0047

  • Ibarakihigashi National Hospial

    Ibaraki, Naka-gun, 319-1113

  • Toranomon Hospital Kajigaya

    Kanagawa, Kawasaki, 213-0015

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, Yokohama, 236-0051

  • Tohoku University Hospital

    Miyagi, Sendai, 980-8574

  • Tenri Hospital

    Nara, Tenri, 632-8552

  • Kindai University Hospital

    Osaka, Osaka-sayama, 589-8511

  • Saitama Cardiovascular and Respiratory Center

    Saitama, Kumagaya, 360-0105

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakai, Osaka, 591-8555

  • Jichi Medical University Hospital

    Tochigi, Shimotsuke, 329-0498

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-0042

  • Tokyo Medical and Dental University

    Tokyo, Bunkyo-ku, 113-8519

  • Nippon Medical School Hospital

    Tokyo, Bunkyo-ku, 113-8603

  • Fukujuji Hospital

    Tokyo, Kiyose, 204-0022

  • Toranomon Hospital

    Tokyo, Minato-ku, 105-0001

  • The Jikei University Hospital

    Tokyo, Minato-ku, 105-0003

  • Toho University Omori Medical Center

    Tokyo, Ota-ku, 143-0015

  • JR Tokyo General Hospital

    Tokyo, Shibuya-ku, 151-0053

  • Tokyo Medical University Hospital

    Tokyo, Shinjuku-ku, 160-0023

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, Shinjuku-ku, 162-8555

  • Tottori University Hospital

    Tottori, Yonago, 683-0826

Other trials in Japan

Germany15 sites

  • CIMS Studienzentrum Bamberg GmbH

    Bamberg, 96049

  • Helios Klinikum Emil von Behring

    Berlin, 14165

  • Evangelische Lungenklinik Berlin

    Buch, 13125

  • Universitätsklinikum Carl Gustav Carus Dresden

    Coswig, 01640

  • Klinik Donaustauf

    Donaustauf, 93093

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

  • Universitätsklinikum Freiburg

    Freiburg/Breisgau, 79106

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen, 35392

  • Universitätsmedizin Greifswald

    Greifswald, 17475

  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927

  • Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Klinikum der Universität München - Campus Großhadern

    München, 81377

  • Universitätsklinikum Münster

    Münster, 48149

Other trials in Germany

France13 sites

  • HOP Avicenne

    Bobigny, 93009

  • HOP Bocage

    Dijon, 21079

  • HOP Calmette

    Lille, 59037

  • HOP Louis Pradel

    Lyon, 69677

  • HOP Nord

    Marseille, 13015

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Pasteur

    Nice, 06002

  • HOP Européen G. Pompidou

    Paris, 75015

  • HOP Bichat

    Paris, 75877

  • HOP Tenon

    Paris, 75970

  • HOP Maison Blanche

    Reims, 51092

  • HOP Pontchaillou

    Rennes, 35033

  • HOP Larrey

    Toulouse, 31059

Other trials in France

China11 sites

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Friendship Hospital

    Beijing, 100050

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Xiangya Hospital, Central South University

    Changsha, 410008

  • West China Hospital

    Chengdu, 610042

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006

  • Zhongshan Hospital Fudan University

    Shanghai, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • General Hospital of Shenyang Military Region

    Shenyang, 110015

  • Xijing Hospital

    Xi'an, 710032

  • General Hospital of Ningxia Medical University

    Yinchuan, 750004

Other trials in China

Italy11 sites

  • Osp. Clin. SS. Anunziata

    Chieti Scalo, 56100

  • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

    Forlì, 47100

  • Osp. S. Giuseppe Fatebenefratelli

    Milan, 20123

  • Università di Modena e Reggio Emilia

    Modena, 41100

  • A.O. San Gerardo di Monza

    Monza, 20052

  • Università Federico II

    Naples, 80131

  • Università degli Studi Padova

    Padova, 35128

  • Ospedale di Cisanello

    Pisa, 56100

  • Ospedale di Cisanello

    Pisa, 56124

  • Pol. Universitario Tor Vergata

    Roma, 00133

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

Other trials in Italy

United Kingdom8 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • Queen Elizabeth Hospital

    Birmingham, B15 2GW

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • St James's University Hospital

    Leeds, LS9 7TF

  • Aintree University Hospital

    Liverpool, L9 7AL

  • Royal Brompton Hospital

    London, SW3 6NP

  • Churchill Hospital

    Oxford, OX3 7LJ

  • Southmead Hospital

    Westbury on Trym, BS10 5NB

Other trials in United Kingdom

India6 sites

  • Mehta Hospital & Cardiopulmonary Care Centre

    Ahmedabad, 380054

  • Chest & Maternity Center

    Bangalore, 560010

  • Asthma Bhawan

    Jaipur, 302023

  • National Allergy Asthma Bronchitis Institute, Kolkata

    Kolkata, 700017

  • P.D. Hinduja National Hospital

    Mumbai, 400016

  • Jahingir Clinical Development Centre

    Pune, 411001

Other trials in India

South Korea6 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767

  • Gachon University Gil Medical Center

    Incheon, 405-760

  • Seoul National University Hospital

    Seoul, 110-744

  • Asan Medical Center

    Seoul, 138-736

  • Soonchunhyang University Hospital Seoul

    Seoul, 140-743

  • The Catholic University of Korea, Yeouido St.Mary's Hospital

    Seoul, 150-713

Other trials in South Korea

Portugal5 sites

  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3041-801

  • CHLC, EPE - Hospital de Santa Marta

    Lisbon, 1196-024

  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente

    Lisbon, 1750-001 L

  • Centro Hospitalar Universitário São João,EPE

    Porto, 4202-451

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Turkey (Türkiye)5 sites

  • Ankara Universitesi Tip Fakultesi

    Ankara, 06100

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Yedikule Gog. Hst. EAH

    Istanbul, 34760

  • Ege Universitesi T.F.

    Izmir, 35100

  • Dr.Suat Seren EAH

    Izmir, 35120

Other trials in Turkey (Türkiye)

Australia4 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Repatriation General Hospital

    Concord, New South Wales, 2137

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Alfred Hospital

    Melbourne, Victoria, 3000

Other trials in Australia

Belgium4 sites

  • ULB Hopital Erasme

    Brussels, 1070

  • Brussels - UNIV UZ Brussel

    Brussels, 1090

  • UZ Leuven

    Leuven, 3000

  • Yvoir - UNIV UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Spain4 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Nuestra Señora de Valme

    Seville, 41014

Other trials in Spain

Czechia3 sites

  • Thomayer Hospital

    Prague, 140 59

  • University Hospital Na Bulovce, Prague

    Prague, 180 81

  • Masaryk Hospital, Usti nad Labem

    Ústí nad Labem, 401 13

Other trials in Czechia

Greece3 sites

  • Athens Hospital of Chest Diseases "Sotiria"

    Athens, 11527

  • University Hospital of Heraklion, University Pulmonology Cl

    Heraklion, 71100

  • General University Hospital of Larissa

    Larissa, 41110

Other trials in Greece

Netherlands3 sites

  • OLVG, locatie Oosterpark

    Amsterdam, 1091 AC

  • St. Antonius ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3435 CM

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CE

Other trials in Netherlands

Canada2 sites

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

Finland2 sites

  • HYKS Keuhkosairauksien tutkimusyksikkö

    Helsinki, 00029

  • Mehiläinen Kielotie, Vantaa

    Vantaa, 01300

Other trials in Finland

Israel2 sites

  • Rabin Medical Center Beilinson

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Chile1 site

  • Instituto Nacional del Tórax

    Santiago, 7500000

Other trials in Chile

Ireland1 site

  • Mater Misericordiae University Hospital

    Dublin, 7

Other trials in Ireland

Mexico1 site

  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

    Mexico City, 14080

Other trials in Mexico

Russia1 site

  • Scientific Research Institute of Pulmonology

    Saint Petersburg, 197022

Other trials in Russia

About this study

Official title: An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

Being tested
Nintedanib
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.

  • NintedanibDrug

    Also called BIBF 1120

    Nintedanib twice a day

Study groups in NCT01619085
Study groupRoleWhat they receive
All subjectsExperimentalpatient to receive a capsule containing Nintedanib twice a day
Receives: Drug: Nintedanib

What is being measured

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

  1. Incidence of Adverse Events (AEs)

    This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.

    Measured: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.

Timeline

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

  1. First posted14 Jun 2012 (estimated)
  2. Study start6 Jun 2012
  3. Primary completion5 Jul 2017
  4. Study completion1 Feb 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01619085
Sponsor's protocol ID
1199.33
Other IDs
2011-002766-21
Status last verified
Feb 2022
First submitted
6 Jun 2012
Last updated
25 Mar 2022

Publications

  • Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14.

    PubMed 30224318

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 173 sites in 24 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 2 inclusion and 10 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 173 sites in United States, Japan, Germany, France, China and 19 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Adverse Events (AEs) (time frame: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.). 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 NCT01619085, 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 25 Mar 2022.

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