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

February 28, 2022 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

752

Phase

  • Phase 3

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2137
        • Repatriation General Hospital
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Melbourne, Victoria, Australia, 3000
        • Alfred Hospital
  • Belgium
      • Brussel, Belgium, 1090
        • Brussels - UNIV UZ Brussel
      • Bruxelles, Belgium, 1070
        • ULB Hopital Erasme
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Yvoir, Belgium, 5530
        • Yvoir - UNIV UCL de Mont-Godinne
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
  • Chile
      • Santiago de Chile, Chile, 7500000
        • Instituto Nacional del Tórax
  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 100050
        • Beijing Friendship Hospital
      • Changsha, China, 410008
        • Xiangya Hospital, Central South University
      • Chengdu, China, 610042
        • West China Hospital
      • Nanchang, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
      • Shenyang, China, 110015
        • General Hospital of Shenyang Military Region
      • Xi'An, China, 710032
        • Xijing Hospital
      • Yinchuan, China, 750004
        • General Hospital of Ningxia Medical University
  • Czechia
      • Prague 4, Czechia, 140 59
        • Thomayer Hospital
      • Prague 8, Czechia, 180 81
        • University Hospital Na Bulovce, Prague
      • Usti nad Labem, Czechia, 401 13
        • Masaryk Hospital, Usti nad Labem
  • Finland
      • Helsinki, Finland, 00029
        • HYKS Keuhkosairauksien tutkimusyksikkö
      • Vantaa, Finland, 01300
        • Mehiläinen Kielotie, Vantaa
  • France
      • Bobigny, France, 93009
        • HOP Avicenne
      • Dijon, France, 21079
        • HOP Bocage
      • Lille Cedex, France, 59037
        • HOP Calmette
      • Lyon cedex, France, 69677
        • HOP Louis Pradel
      • Marseille, France, 13015
        • HOP Nord
      • Montpellier, France, 34295
        • HOP Arnaud de Villeneuve
      • Nice, France, 06002
        • HOP Pasteur
      • Paris, France, 75970
        • HOP Tenon
      • Paris, France, 75877
        • HOP Bichat
      • Paris, France, 75015
        • HOP Européen G. Pompidou
      • Reims, France, 51092
        • HOP Maison Blanche
      • Rennes Cedex 9, France, 35033
        • HOP Pontchaillou
      • Toulouse, France, 31059
        • HOP Larrey
  • Germany
      • Bamberg, Germany, 96049
        • CIMS Studienzentrum Bamberg GmbH
      • Berlin, Germany, 14165
        • Helios Klinikum Emil Von Behring
      • Berlin-Buch, Germany, 13125
        • Evangelische Lungenklinik Berlin
      • Coswig, Germany, 01640
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Donaustauf, Germany, 93093
        • Klinik Donaustauf
      • Essen, Germany, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Freiburg/Breisgau, Germany, 79106
        • Universitätsklinikum Freiburg
      • Gießen, Germany, 35392
        • Universitätsklinikum Gießen und Marburg GmbH
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald
      • Grosshansdorf, Germany, 22927
        • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
      • Heidelberg, Germany, 69126
        • Universitätsklinikum Heidelberg
      • Immenhausen, Germany, 34376
        • Lungenfachklinik Immenhausen
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • München, Germany, 81377
        • Klinikum der Universität München - Campus Grosshadern
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
  • Greece
      • Athens, Greece, 11527
        • Athens Hospital of Chest Diseases "Sotiria"
      • Heraklion, Greece, 71100
        • University Hospital of Heraklion, University Pulmonology Cl
      • Larisa, Greece, 41110
        • General University Hospital of Larissa
  • India
      • Ahmedabad, India, 380054
        • Mehta Hospital & Cardiopulmonary Care Centre
      • Bangalore, India, 560010
        • Chest & Maternity Center
      • Jaipur, India, 302023
        • Asthma Bhawan
      • Kolkatta, India, 700017
        • National Allergy Asthma Bronchitis Institute, Kolkata
      • Mumbai, India, 400016
        • P.D. Hinduja National Hospital
      • Pune, India, 411001
        • Jahingir Clinical Development Centre
  • Ireland
      • Dublin, Ireland, 7
        • Mater Misericordiae University Hospital
  • Israel
      • Petah Tiqwa, Israel, 49100
        • Rabin Medical Center Beilinson
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
  • Italy
      • Chieti Scalo, Italy, 56100
        • Osp. Clin. SS. Anunziata
      • Forli', Italy, 47100
        • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
      • Milano, Italy, 20123
        • Osp. S. Giuseppe Fatebenefratelli
      • Modena, Italy, 41100
        • Università di Modena e Reggio Emilia
      • Monza, Italy, 20052
        • A.O. San Gerardo di Monza
      • Napoli, Italy, 80131
        • Università Federico II
      • Padova, Italy, 35128
        • Università degli Studi Padova
      • Pisa, Italy, 56100
        • Ospedale di Cisanello
      • Pisa, Italy, 56124
        • Ospedale di Cisanello
      • Roma, Italy, 00133
        • Pol. Universitario Tor Vergata
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Japan
      • Aichi, Nagoya, Japan, 466-8560
        • Nagoya University Hospital
      • Aichi, Seto, Japan, 489-8642
        • Tosei General Hospital
      • Gifu, Ogaki, Japan, 503-0864
        • Ogaki Municipal Hospital
      • Himeji, Hyogo, Japan, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Hyogo, Kobe, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Ibaraki, Naka-gun, Japan, 319-1113
        • Ibarakihigashi National Hospial
      • Kanagawa, Kawasaki, Japan, 213-0015
        • Toranomon Hospital Kajigaya
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Miyagi, Sendai, Japan, 980-8574
        • Tohoku University Hospital
      • Nara, Tenri, Japan, 632-8552
        • Tenri Hospital
      • Osaka, Osaka-sayama, Japan, 589-8511
        • Kindai University Hospital
      • Saitama, Kumagaya, Japan, 360-0105
        • Saitama Cardiovascular and Respiratory Center
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center
      • Tochigi, Shimotsuke, Japan, 329-0498
        • Jichi Medical University Hospital
      • Tokushima, Tokushima, Japan, 770-0042
        • Tokushima University Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8603
        • Nippon Medical School Hospital
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Tokyo Medical and Dental University
      • Tokyo, Kiyose, Japan, 204-0022
        • Fukujuji Hospital
      • Tokyo, Minato-ku, Japan, 105-0001
        • Toranomon Hospital
      • Tokyo, Minato-ku, Japan, 105-0003
        • The Jikei University Hospital
      • Tokyo, Ota-ku, Japan, 143-0015
        • Toho University Omori Medical Center
      • Tokyo, Shibuya-ku, Japan, 151-0053
        • JR Tokyo General Hospital
      • Tokyo, Shinjuku-ku, Japan, 162-8555
        • Center Hospital of the National Center for Global Health and Medicine
      • Tokyo, Shinjuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tottori, Yonago, Japan, 683-0826
        • Tottori University Hospital
  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-767
        • Soon Chun Hyang University Hospital Bucheon
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 140-743
        • Soonchunhyang University Hospital Seoul
      • Seoul, Korea, Republic of, 150-713
        • The Catholic University of Korea, Yeouido St.Mary's Hospital
  • Mexico
      • Mexico DF, Mexico, 14080
        • Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
        • OLVG, locatie Oosterpark
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius ziekenhuis, locatie Nieuwegein
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum
  • Portugal
      • Coimbra, Portugal, 3041-801
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
      • Lisboa, Portugal, 1750-001 L
        • Centro Hospitalar Lisboa Norte Hospital Pulido Valente
      • Lisboa, Portugal, 1196-024
        • CHLC, EPE - Hospital de Santa Marta
      • Porto, Portugal, 4202-451
        • Centro Hospitalar Universitário São João,EPE
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia
  • Russian Federation
      • St. Petersburg, Russian Federation, 197022
        • Scientific Research Institute of Pulmonology
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • L´Hospitalet de Llobregat, Spain, 08907
        • Hospital de Bellvitge
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Universitesi Tip Fakultesi
      • Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi
      • Istanbul, Turkey, 34760
        • Yedikule Gog. Hst. EAH
      • Izmir, Turkey, 35100
        • Ege Universitesi T.F.
      • Izmir, Turkey, 35120
        • Dr.Suat Seren EAH
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
      • Westbury On Trym, United Kingdom, BS10 5NB
        • Southmead Hospital
  • United States
    • Alabama
      • Jasper, Alabama, United States, 35501
        • Jasper Summit Research, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
    • California
      • Los Angeles, California, United States, 90095-1690
        • University of California
      • San Francisco, California, United States, 94143
        • University of California
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Torrance, California, United States, 90505
        • University of California
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Western Connecticut Medical Group
      • Stamford, Connecticut, United States, 06902
        • Pulmonary Assoc of Stamford
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic
    • Georgia
      • Austell, Georgia, United States, 30106
        • Georgia Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Wichita, Kansas, United States, 67208
        • Via Christi Clinic, PA
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minnesota Lung Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • The Lung Research Center, LLC
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Albany, New York, United States, 12205
        • Pulmonary and Critical Care Associates
      • Jamaica, New York, United States, 11418
        • Jamaica Hospital Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0565
        • University of Cincinnati
      • Toledo, Ohio, United States, 43608
        • ID Clinical Research, LTD
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232-5735
        • Vanderbilt University Medical Center
      • Shelbyville, Tennessee, United States, 37160
        • FDC Seifer PLC Pulmonary
    • Texas
      • Dallas, Texas, United States, 75235-8550
        • University of Texas Southwestern Medical Center
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • McKinney, Texas, United States, 75069-1769
        • Metroplex Pul and Sleep Ctr
      • San Antonio, Texas, United States, 78229
        • Diagnostics Research Group
    • Vermont
      • Colchester, Vermont, United States, 05446
        • Vermont Lung Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Lynchburg, Virginia, United States, 24501
        • Lynchburg Pulmonary Associates
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

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

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  1. 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)
  2. Bilirubin > 1.5 fold ULN
  3. Bleeding risk
  4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
  5. New major thrombo-embolic events developed after completion of the parent trial.
  6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
  7. 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.
  8. 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.
  9. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
  10. 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.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: All subjects
patient to receive a capsule containing Nintedanib twice a day
Drug: Nintedanib
Nintedanib twice a day
Other Names:
  • BIBF 1120

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

June 6, 2012

Primary Completion (ACTUAL)

July 5, 2017

Study Completion (ACTUAL)

February 1, 2021

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (ESTIMATE)

June 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2022

Last Update Submitted That Met QC Criteria

February 28, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1199.33
  • 2011-002766-21 (EUDRACT_NUMBER)

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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