Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT01619085
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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 with BIBF 1120.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All subjects Nintedanib patient to receive a capsule containing Nintedanib twice a day
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (170)
Yvoir - UNIV UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
Instituto Nacional del Tórax
🇨🇱Santiago de Chile, Chile
Peking University People's Hospital
🇨🇳Beijing, China
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Beijing Friendship Hospital
🇨🇳Beijing, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Zhongshan Hospital Fudan University
🇨🇳Shanghai, China
HYKS Keuhkosairauksien tutkimusyksikkö
🇫🇮Helsinki, Finland
HOP Louis Pradel
🇫🇷Lyon cedex, France
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
National Allergy Asthma Bronchitis Institute, Kolkata
🇮🇳Kolkatta, India
Rabin Medical Center Beilinson
🇮🇱Petah Tiqwa, Israel
Osp. Clin. SS. Anunziata
🇮🇹Chieti Scalo, Italy
HOP Nord
🇫🇷Marseille, France
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
HOP Européen G. Pompidou
🇫🇷Paris, France
HOP Pontchaillou
🇫🇷Rennes Cedex 9, France
CIMS Studienzentrum Bamberg GmbH
🇩🇪Bamberg, Germany
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany
HOP Bichat
🇫🇷Paris, France
Evangelische Lungenklinik Berlin
🇩🇪Berlin-Buch, Germany
Klinikum der Universität München - Campus Großhadern
🇩🇪München, Germany
Athens Hospital of Chest Diseases "Sotiria"
🇬🇷Athens, Greece
General University Hospital of Larissa
🇬🇷Larisa, Greece
Jahingir Clinical Development Centre
🇮🇳Pune, India
Universitätsklinikum Münster
🇩🇪Münster, Germany
Chest & Maternity Center
🇮🇳Bangalore, India
Tokushima University Hospital
🇯🇵Tokushima, Tokushima, Japan
Asthma Bhawan
🇮🇳Jaipur, India
P.D. Hinduja National Hospital
🇮🇳Mumbai, India
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Ospedale di Cisanello
🇮🇹Pisa, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
🇲🇽Mexico DF, Mexico
Ankara Universitesi Tip Fakultesi
🇹🇷Ankara, Turkey
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitário São João,EPE
🇵🇹Porto, Portugal
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
University of California
🇺🇸Torrance, California, United States
Western Connecticut Medical Group
🇺🇸Danbury, Connecticut, United States
Pulmonary Assoc of Stamford
🇺🇸Stamford, Connecticut, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Pulmonary and Critical Care Associates
🇺🇸Albany, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Vermont Lung Center
🇺🇸Colchester, Vermont, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
The Catholic University of Korea, Yeouido St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Ege Universitesi T.F.
🇹🇷Izmir, Turkey
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Minnesota Lung Center
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Churchill Hospital
🇬🇧Oxford, United Kingdom
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Jasper Summit Research, LLC
🇺🇸Jasper, Alabama, United States
Pulmonary Associates
🇺🇸Phoenix, Arizona, United States
Via Christi Clinic, PA
🇺🇸Wichita, Kansas, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Cleveland Clinic
🇺🇸Weston, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Georgia Clinical Research
🇺🇸Austell, Georgia, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
ID Clinical Research, LTD
🇺🇸Toledo, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
FDC Seifer PLC Pulmonary
🇺🇸Shelbyville, Tennessee, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Metroplex Pul and Sleep Ctr
🇺🇸McKinney, Texas, United States
Lynchburg Pulmonary Associates
🇺🇸Lynchburg, Virginia, United States
Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
ULB Hopital Erasme
🇧🇪Bruxelles, Belgium
Brussels - UNIV UZ Brussel
🇧🇪Brussel, Belgium
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
West China Hospital
🇨🇳Chengdu, China
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China
General Hospital of Shenyang Military Region
🇨🇳Shenyang, China
Xiangya Hospital, Central South University
🇨🇳Changsha, China
Xijing Hospital
🇨🇳Xi'An, China
Thomayer Hospital
🇨🇿Prague 4, Czechia
University Hospital Na Bulovce, Prague
🇨🇿Prague 8, Czechia
Mehiläinen Kielotie, Vantaa
🇫🇮Vantaa, Finland
HOP Avicenne
🇫🇷Bobigny, France
HOP Arnaud de Villeneuve
🇫🇷Montpellier, France
HOP Maison Blanche
🇫🇷Reims, France
HOP Tenon
🇫🇷Paris, France
HOP Bocage
🇫🇷Dijon, France
HOP Larrey
🇫🇷Toulouse, France
HOP Pasteur
🇫🇷Nice, France
Helios Klinikum Emil von Behring
🇩🇪Berlin, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Coswig, Germany
Klinik Donaustauf
🇩🇪Donaustauf, Germany
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Mehta Hospital & Cardiopulmonary Care Centre
🇮🇳Ahmedabad, India
Università di Modena e Reggio Emilia
🇮🇹Modena, Italy
Università Federico II
🇮🇹Napoli, Italy
A.O. San Gerardo di Monza
🇮🇹Monza, Italy
Università degli Studi Padova
🇮🇹Padova, Italy
Nagoya University Hospital
🇯🇵Aichi, Nagoya, Japan
Ogaki Municipal Hospital
🇯🇵Gifu, Ogaki, Japan
Pol. Universitario Tor Vergata
🇮🇹Roma, Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
National Hospital Organization Himeji Medical Center
🇯🇵Himeji, Hyogo, Japan
Kobe City Medical Center General Hospital
🇯🇵Hyogo, Kobe, Japan
Toranomon Hospital Kajigaya
🇯🇵Kanagawa, Kawasaki, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Shimotsuke, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Sakai, Osaka, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Fukujuji Hospital
🇯🇵Tokyo, Kiyose, 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
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
OLVG, locatie Oosterpark
🇳🇱Amsterdam, Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
🇳🇱Nieuwegein, Netherlands
Hospital Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Hospital de Bellvitge
🇪🇸L´Hospitalet de Llobregat, Spain
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
🇵🇹Coimbra, Portugal
CHLC, EPE - Hospital de Santa Marta
🇵🇹Lisboa, Portugal
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Scientific Research Institute of Pulmonology
🇷🇺St. Petersburg, Russian Federation
Istanbul Universitesi Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Yedikule Gog. Hst. EAH
🇹🇷Istanbul, Turkey
Dr.Suat Seren EAH
🇹🇷Izmir, Turkey
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
St James's University Hospital
🇬🇧Leeds, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, United Kingdom
Southmead Hospital
🇬🇧Westbury On Trym, United Kingdom
Masaryk Hospital, Usti nad Labem
🇨🇿Usti nad Labem, Czechia
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
UZ Leuven
🇧🇪Leuven, Belgium
HOP Calmette
🇫🇷Lille Cedex, France
Universitätsklinikum Freiburg
🇩🇪Freiburg/Breisgau, Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
🇩🇪Grosshansdorf, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
University Hospital of Heraklion, University Pulmonology Cl
🇬🇷Heraklion, Greece
Kaplan Medical Center
🇮🇱Rehovot, Israel
Osp. S. Giuseppe Fatebenefratelli
🇮🇹Milano, Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
🇮🇹Forli', Italy
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Kanagawa, Yokohama, Japan
Ibarakihigashi National Hospial
🇯🇵Ibaraki, Naka-gun, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Kindai University Hospital
🇯🇵Osaka, Osaka-sayama, Japan
Tenri Hospital
🇯🇵Nara, Tenri, Japan
Saitama Cardiovascular and Respiratory Center
🇯🇵Saitama, Kumagaya, Japan
Toho University Omori Medical Center
🇯🇵Tokyo, Ota-ku, Japan
Tokyo Medical and Dental University
🇯🇵Tokyo, Bunkyo-ku, Japan
The Jikei University Hospital
🇯🇵Tokyo, Minato-ku, Japan
Toranomon Hospital
🇯🇵Tokyo, Minato-ku, Japan
JR Tokyo General Hospital
🇯🇵Tokyo, Shibuya-ku, Japan
Royal Brompton Hospital
🇬🇧London, United Kingdom
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States