Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT01619085
Last Updated: 2022-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
752 participants
INTERVENTIONAL
2012-06-06
2021-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All subjects
patient to receive a capsule containing Nintedanib twice a day
Nintedanib
Nintedanib twice a day
Interventions
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Nintedanib
Nintedanib twice a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.
Exclusion Criteria
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.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Jasper Summit Research, LLC
Jasper, Alabama, United States
Pulmonary Associates
Phoenix, Arizona, United States
University of California
Los Angeles, California, United States
University of California
San Francisco, California, United States
Sansum Clinic
Santa Barbara, California, United States
Stanford University Medical Center
Stanford, California, United States
University of California
Torrance, California, United States
Western Connecticut Medical Group
Danbury, Connecticut, United States
Pulmonary Assoc of Stamford
Stamford, Connecticut, United States
Cleveland Clinic
Weston, Florida, United States
Georgia Clinical Research
Austell, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Via Christi Clinic, PA
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Minnesota Lung Center
Minneapolis, Minnesota, United States
The Lung Research Center, LLC
Chesterfield, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Pulmonary and Critical Care Associates
Albany, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
New York Presbyterian Hospital
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
ID Clinical Research, LTD
Toledo, Ohio, United States
The Oregon Clinic
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
FDC Seifer PLC Pulmonary
Shelbyville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
DCOL Center for Clinical Research
Longview, Texas, United States
Metroplex Pul and Sleep Ctr
McKinney, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Vermont Lung Center
Colchester, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Lynchburg Pulmonary Associates
Lynchburg, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Repatriation General Hospital
Concord, New South Wales, Australia
Frankston Hospital
Frankston, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
ULB Hopital Erasme
Brussels, , Belgium
Brussels - UNIV UZ Brussel
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, , Belgium
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Instituto Nacional del Tórax
Santiago, , Chile
Peking University People's Hospital
Beijing, , China
Beijing Friendship Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Xiangya Hospital, Central South University
Changsha, , China
West China Hospital
Chengdu, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
General Hospital of Shenyang Military Region
Shenyang, , China
Xijing Hospital
Xi'an, , China
General Hospital of Ningxia Medical University
Yinchuan, , China
Thomayer Hospital
Prague, , Czechia
University Hospital Na Bulovce, Prague
Prague, , Czechia
Masaryk Hospital, Usti nad Labem
Ústí nad Labem, , Czechia
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, , Finland
Mehiläinen Kielotie, Vantaa
Vantaa, , Finland
HOP Avicenne
Bobigny, , France
HOP Bocage
Dijon, , France
HOP Calmette
Lille, , France
HOP Louis Pradel
Lyon, , France
HOP Nord
Marseille, , France
HOP Arnaud de Villeneuve
Montpellier, , France
HOP Pasteur
Nice, , France
HOP Européen G. Pompidou
Paris, , France
HOP Bichat
Paris, , France
HOP Tenon
Paris, , France
HOP Maison Blanche
Reims, , France
HOP Pontchaillou
Rennes, , France
HOP Larrey
Toulouse, , France
CIMS Studienzentrum Bamberg GmbH
Bamberg, , Germany
Helios Klinikum Emil von Behring
Berlin, , Germany
Evangelische Lungenklinik Berlin
Buch, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Coswig, , Germany
Klinik Donaustauf
Donaustauf, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg/Breisgau, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Lungenfachklinik Immenhausen
Immenhausen, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Klinikum der Universität München - Campus Großhadern
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Athens Hospital of Chest Diseases "Sotiria"
Athens, , Greece
University Hospital of Heraklion, University Pulmonology Cl
Heraklion, , Greece
General University Hospital of Larissa
Larissa, , Greece
Mehta Hospital & Cardiopulmonary Care Centre
Ahmedabad, , India
Chest & Maternity Center
Bangalore, , India
Asthma Bhawan
Jaipur, , India
National Allergy Asthma Bronchitis Institute, Kolkata
Kolkata, , India
P.D. Hinduja National Hospital
Mumbai, , India
Jahingir Clinical Development Centre
Pune, , India
Mater Misericordiae University Hospital
Dublin, , Ireland
Rabin Medical Center Beilinson
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Osp. Clin. SS. Anunziata
Chieti Scalo, , Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
Forlì, , Italy
Osp. S. Giuseppe Fatebenefratelli
Milan, , Italy
Università di Modena e Reggio Emilia
Modena, , Italy
A.O. San Gerardo di Monza
Monza, , Italy
Università Federico II
Napoli, , Italy
Università degli Studi Padova
Padua, , Italy
Ospedale di Cisanello
Pisa, , Italy
Ospedale di Cisanello
Pisa, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Nagoya University Hospital
Aichi, Nagoya, , Japan
Tosei General Hospital
Aichi, Seto, , Japan
Ogaki Municipal Hospital
Gifu, Ogaki, , Japan
National Hospital Organization Himeji Medical Center
Himeji, Hyogo, , Japan
Kobe City Medical Center General Hospital
Hyogo, Kobe, , Japan
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, , Japan
Toranomon Hospital Kajigaya
Kanagawa, Kawasaki, , Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , Japan
Tohoku University Hospital
Miyagi, Sendai, , Japan
Tenri Hospital
Nara, Tenri, , Japan
Kindai University Hospital
Osaka, Osaka-sayama, , Japan
Saitama Cardiovascular and Respiratory Center
Saitama, Kumagaya, , Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Osaka, , Japan
Jichi Medical University Hospital
Tochigi, Shimotsuke, , Japan
Tokushima University Hospital
Tokushima, Tokushima, , Japan
Tokyo Medical and Dental University
Tokyo, Bunkyo-ku, , Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, , Japan
Fukujuji Hospital
Tokyo, Kiyose, , Japan
Toranomon Hospital
Tokyo, Minato-ku, , Japan
The Jikei University Hospital
Tokyo, Minato-ku, , Japan
Toho University Omori Medical Center
Tokyo, Ota-ku, , Japan
JR Tokyo General Hospital
Tokyo, Shibuya-ku, , Japan
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, , Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, , Japan
Tottori University Hospital
Tottori, Yonago, , Japan
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Mexico City, , Mexico
OLVG, locatie Oosterpark
Amsterdam, , Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
CHLC, EPE - Hospital de Santa Marta
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon, , Portugal
Centro Hospitalar Universitário São João,EPE
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Scientific Research Institute of Pulmonology
Saint Petersburg, , Russia
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Soonchunhyang University Hospital Seoul
Seoul, , South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, , South Korea
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Nuestra Señora de Valme
Seville, , Spain
Ankara Universitesi Tip Fakultesi
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Yedikule Gog. Hst. EAH
Istanbul, , Turkey (Türkiye)
Ege Universitesi T.F.
Izmir, , Turkey (Türkiye)
Dr.Suat Seren EAH
Izmir, , Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Southmead Hospital
Westbury on Trym, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2011-002766-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199.33
Identifier Type: -
Identifier Source: org_study_id
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