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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nintedanib
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jasper Summit Research, LLC
  • Pulmonary Associates
  • University of California
  • University of California
  • Sansum Clinic
  • Stanford University Medical Center
  • University of California
  • Western Connecticut Medical Group
  • Pulmonary Assoc of Stamford
  • Cleveland Clinic
  • Georgia Clinical Research
  • University of Chicago
  • Via Christi Clinic, PA
  • Baptist Health Lexington
  • Minnesota Lung Center
  • The Lung Research Center, LLC
  • Dartmouth-Hitchcock Medical Center
  • Pulmonary and Critical Care Associates
  • Jamaica Hospital Medical Center
  • New York Presbyterian Hospital
  • University of Cincinnati
  • ID Clinical Research, LTD
  • The Oregon Clinic
  • University of Pennsylvania
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • FDC Seifer PLC Pulmonary
  • University of Texas Southwestern Medical Center
  • DCOL Center for Clinical Research
  • Metroplex Pul and Sleep Ctr
  • Diagnostics Research Group
  • Vermont Lung Center
  • Inova Fairfax Hospital
  • Lynchburg Pulmonary Associates
  • University of Wisconsin
  • Royal Prince Alfred Hospital
  • Repatriation General Hospital
  • Frankston Hospital
  • Alfred Hospital
  • Brussels - UNIV UZ Brussel
  • ULB Hopital Erasme
  • UZ Leuven
  • Yvoir - UNIV UCL de Mont-Godinne
  • QEII Health Sciences Centre
  • St. Joseph's Healthcare Hamilton
  • Instituto Nacional del Tórax
  • Peking University People's Hospital
  • Beijing Friendship Hospital
  • Peking Union Medical College Hospital
  • Xiangya Hospital, Central South University
  • West China Hospital
  • The First Affiliated Hospital of Nanchang University
  • Zhongshan Hospital Fudan University
  • Shanghai Pulmonary Hospital
  • General Hospital of Shenyang Military Region
  • Xijing Hospital
  • General Hospital of Ningxia Medical University
  • Thomayer Hospital
  • University Hospital Na Bulovce, Prague
  • Masaryk Hospital, Usti nad Labem
  • HYKS Keuhkosairauksien tutkimusyksikkö
  • Mehiläinen Kielotie, Vantaa
  • HOP Avicenne
  • HOP Bocage
  • HOP Calmette
  • HOP Louis Pradel
  • HOP Nord
  • HOP Arnaud de Villeneuve
  • HOP Pasteur
  • HOP Européen G. Pompidou
  • HOP Bichat
  • HOP Tenon
  • HOP Maison Blanche
  • HOP Pontchaillou
  • HOP Larrey
  • CIMS Studienzentrum Bamberg GmbH
  • Evangelische Lungenklinik Berlin
  • Helios Klinikum Emil von Behring
  • Universitätsklinikum Carl Gustav Carus Dresden
  • Klinik Donaustauf
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Universitätsklinikum Freiburg
  • Universitätsklinikum Gießen und Marburg GmbH
  • Universitätsmedizin Greifswald
  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
  • Universitätsklinikum Heidelberg
  • Lungenfachklinik Immenhausen
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Klinikum der Universität München - Campus Großhadern
  • Universitätsklinikum Münster
  • Athens Hospital of Chest Diseases "Sotiria"
  • University Hospital of Heraklion, University Pulmonology Cl
  • General University Hospital of Larissa
  • Mehta Hospital & Cardiopulmonary Care Centre
  • Chest & Maternity Center
  • Asthma Bhawan
  • National Allergy Asthma Bronchitis Institute, Kolkata
  • P.D. Hinduja National Hospital
  • Jahingir Clinical Development Centre
  • Mater Misericordiae University Hospital
  • Rabin Medical Center Beilinson
  • Kaplan Medical Center
  • Osp. Clin. SS. Anunziata
  • Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
  • Osp. S. Giuseppe Fatebenefratelli
  • Università di Modena e Reggio Emilia
  • A.O. San Gerardo di Monza
  • Università Federico II
  • Università degli Studi Padova
  • Ospedale di Cisanello
  • Ospedale di Cisanello
  • Pol. Universitario Tor Vergata
  • A.O.U. Senese Policlinico Santa Maria alle Scotte
  • Nagoya University Hospital
  • Tosei General Hospital
  • Ogaki Municipal Hospital
  • National Hospital Organization Himeji Medical Center
  • Kobe City Medical Center General Hospital
  • Ibarakihigashi National Hospial
  • Toranomon Hospital Kajigaya
  • Kanagawa Cardiovascular and Respiratory Center
  • Tohoku University Hospital
  • Tenri Hospital
  • Kindai University Hospital
  • Saitama Cardiovascular and Respiratory Center
  • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Jichi Medical University Hospital
  • Tokushima University Hospital
  • Tokyo Medical and Dental University
  • Nippon Medical School Hospital
  • Fukujuji Hospital
  • Toranomon Hospital
  • The Jikei University Hospital
  • Toho University Omori Medical Center
  • JR Tokyo General Hospital
  • Tokyo Medical University Hospital
  • Center Hospital of the National Center for Global Health and Medicine
  • Tottori University Hospital
  • Soon Chun Hyang University Hospital Bucheon
  • Gachon University Gil Medical Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Soonchunhyang University Hospital Seoul
  • The Catholic University of Korea, Yeouido St.Mary's Hospital
  • Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
  • OLVG, locatie Oosterpark
  • St. Antonius ziekenhuis, locatie Nieuwegein
  • Erasmus Medisch Centrum
  • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
  • CHLC, EPE - Hospital de Santa Marta
  • Centro Hospitalar Lisboa Norte Hospital Pulido Valente
  • Centro Hospitalar Universitário São João,EPE
  • Centro Hospitalar de Vila Nova de Gaia
  • Scientific Research Institute of Pulmonology
  • Hospital Vall d'Hebron
  • Hospital Clínic de Barcelona
  • Hospital de Bellvitge
  • Hospital Nuestra Señora de Valme
  • Ankara Universitesi Tip Fakultesi
  • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Yedikule Gog. Hst. EAH
  • Ege Universitesi T.F.
  • Dr.Suat Seren EAH
  • Aberdeen Royal Infirmary
  • Queen Elizabeth Hospital
  • Birmingham Heartlands Hospital
  • St James's University Hospital
  • Aintree University Hospital
  • Royal Brompton Hospital
  • Churchill Hospital
  • Southmead Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

patient to receive a capsule containing Nintedanib twice a day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 6, 2012
Last Updated
February 28, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01619085
Brief Title
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Official Title
An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2012 (Actual)
Primary Completion Date
July 5, 2017 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
752 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
patient to receive a capsule containing Nintedanib twice a day
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Other Intervention Name(s)
BIBF 1120
Intervention Description
Nintedanib twice a day
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Description
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.
Time Frame
From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30224318
Citation
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.
Results Reference
derived
Links:
URL
http://www.mystudywindow.com
Description
Related Info

Learn more about this trial

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

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