Back to resultsA Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Primary Purpose
Lung Diseases, Interstitial
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nintedanib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases, Interstitial
Eligibility Criteria
Inclusion Criteria:
- Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information
Exclusion Criteria:
- Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
- Previous enrolment in this trial. Further exclusion criteria apply.
Sites / Locations
- University of Alabama at Birmingham
- University of California Los Angeles
- University of California Davis
- National Jewish Health
- Yale University School of Medicine
- Pulmonary and Sleep of Tampa Bay
- University of Florida College of Medicine
- Emory University
- University of Chicago
- Loyola University Medical Center
- University of Kansas Medical Center
- Johns Hopkins Hospital
- Pulmonary and Critical Care Associates of Baltimore
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Henry Ford Health System
- Mayo Clinic, Rochester
- The Lung Research Center, LLC
- Creighton University
- Dartmouth-Hitchcock Medical Center
- Icahn School of Medicine at Mount Sinai
- Columbia University Medical Center-New York Presbyterian Hospital
- NewYork-Presbyterian/Weill Cornell Medical Center
- Duke University Medical Center
- The Oregon Clinic
- Penn State Milton S. Hershey Medical Center
- University of Pennsylvania
- Baylor University Medical Center
- University of Texas Southwestern Medical Center
- Diagnostics Research Group
- Medical Arts and Research Center (MARC)
- University of Utah Health Sciences Center
- Inova Fairfax Medical Campus
- Centro Dr. Lazaro Langer S.R.L
- Centro de Investigaciones Metabólicas (CINME)
- CEMER-Centro Medico De Enfermedades Respiratorias
- INSARES
- Instituto Médico de la Fundación Estudios Clínicos
- ULB Hopital Erasme
- UZ Leuven
- Centre Hospitalier Universitaire de Liège
- Yvoir - UNIV UCL de Mont-Godinne
- Winnipeg Clinic
- St. Joseph's Healthcare Hamilton
- Toronto General Hospital
- CHUS Fleurimont
- Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
- Instituto Nacional del Tórax
- Centro de Investigación del Maule
- Peking Union Medical College Hospital
- Nanjing Drum Tower Hospital
- The First Hospital of China Medical University
- HOP Avicenne
- HOP Louis Pradel
- HOP Côte de Nacre
- CHRU Lille
- HOP Nord
- HOP Arnaud de Villeneuve
- HOP Pasteur
- HOP Bichat
- HOP Maison Blanche
- HOP Pontchaillou
- HOP Civil
- HOP Bretonneau
- Universitätsklinikum Bonn AöR
- Fachkrankenhaus Coswig GmbH
- Klinik Donaustauf
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
- Medizinische Hochschule Hannover
- Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
- Petrus-Krankenhaus
- A.O.U. Policlinico Vittorio Emanuele
- Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
- Azienda Ospedaliera Policlinico di Modena
- A.O. San Gerardo di Monza
- Poli Univ A. Gemelli
- A.O.U. Senese Policlinico Santa Maria alle Scotte
- Tosei General Hospital
- Kurume University Hospital
- Sapporo Medical University Hospital
- National Hospital Organization Himeji Medical Center
- Kobe City Medical Center General Hospital
- Ibarakihigashi National Hospial
- Kanagawa Cardiovascular and Respiratory Center
- Saiseikai Kumamoto Hospital
- Tohoku University Hospital
- National Hospital Organization Kinki-Chuo Chest Medical Center
- Osaka Medical College Hospital
- Hamamatsu University Hospital
- Tokushima University Hospital
- Tokyo Medical and Dental University Hospital
- Toranomon Hospital
- JR Tokyo General Hospital
- Center Hospital of the National Center for Global Health and Medicine
- The Catholic University of Korea, Bucheon St.Mary's Hospital
- Seoul National University Bundang Hospital
- Asan Medical Center
- University Clinical Center, Gdansk
- Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
- Norbert Barlicki University Clinical Hospital No.1, Lodz
- Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
- Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
- Res.Inst.-Compl.Iss.Cardi.Dis.
- Central Scientific Research Insitute of Tuberculosis
- Moscow 1st State Med.Univ.n.a.I.M.Sechenov
- 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
- Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
- Hospital Santa Creu i Sant Pau
- Hospital de Galdakao
- Hospital de Bellvitge
- Hospital La Princesa
- Hospital Central de Asturias
- Hospital Son Espases
- Hospital de Canarias
- Hospital Virgen del Rocío
- Royal Infirmary of Edinburgh
- St James's University Hospital
- Royal Brompton Hospital
- Wythenshawe Hospital
- University Hospital Llandough
- Royal Stoke University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nintedanib
Arm Description
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
Outcomes
Primary Outcome Measures
Number of Participants With Any Adverse Events
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03820726
Brief Title
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Official Title
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
435 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nintedanib
Arm Type
Experimental
Arm Description
Patients taking 150 milligram (mg) bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib 150 mg bid in this extension trial. Patients taking 100 mg bid blinded trial medication (active drug or placebo) at the end of INBUILD® started treatment with nintedanib in this extension trial either at 100 mg bid or at an increased dose of 150 mg bid at the discretion of the investigator orally as soft gelatine capsule, twice daily (bid), together with a glass of water (~250 mL), in a dose interval of 12 hours. With an optional dose reduction to 100 mg bid temporarily or permanently to manage adverse events (AEs). The treatment had a duration of 96 weeks or until nintedanib was made available to the patients outside of the clinical trial. Treatment was stopped if any reason for withdrawal was met.
Intervention Type
Drug
Intervention Name(s)
Nintedanib
Intervention Description
Bid
Primary Outcome Measure Information:
Title
Number of Participants With Any Adverse Events
Description
Number of participants with adverse events over the course of the extension trial, AEs defined as any untoward medical occurrence in a patient administered with the investigational product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame
From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients who completed the INBUILD® trial as planned and who did not prematurely discontinue blinded treatment.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Women of childbearing potential (WOCBP)1 must continue to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method, for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information
Exclusion Criteria:
Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in INBUILD®, if the investigator's benefit-risk assessment remains favourable.
Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
Patient not compliant in parent trial (INBUILD®), with trial medication or trial visits, according to investigator's judgement.
Previous enrolment in this trial. Further exclusion criteria apply.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Pulmonary and Sleep of Tampa Bay
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
University of Florida College of Medicine
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Pulmonary and Critical Care Associates of Baltimore
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Lung Research Center, LLC
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
NewYork-Presbyterian/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Arts and Research Center (MARC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Centro Dr. Lazaro Langer S.R.L
City
Alberdi Sur
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Centro de Investigaciones Metabólicas (CINME)
City
C.a.b.a
ZIP/Postal Code
1056
Country
Argentina
Facility Name
CEMER-Centro Medico De Enfermedades Respiratorias
City
Florida
ZIP/Postal Code
B1602DQD
Country
Argentina
Facility Name
INSARES
City
Mendoza
ZIP/Postal Code
M5500CCG
Country
Argentina
Facility Name
Instituto Médico de la Fundación Estudios Clínicos
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
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
Centre Hospitalier Universitaire de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Yvoir - UNIV UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Winnipeg Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 0N2
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
CHUS Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
City
Concepción
ZIP/Postal Code
4070038
Country
Chile
Facility Name
Instituto Nacional del Tórax
City
Providencia, Santiago De Chile
ZIP/Postal Code
7500691
Country
Chile
Facility Name
Centro de Investigación del Maule
City
Talca
ZIP/Postal Code
3465586
Country
Chile
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
HOP Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
HOP Louis Pradel
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HOP Côte de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
HOP Nord
City
Marseille
ZIP/Postal Code
13915
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
06001
Country
France
Facility Name
HOP Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
HOP Maison Blanche
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
HOP Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
HOP Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
HOP Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitätsklinikum Bonn AöR
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Fachkrankenhaus Coswig GmbH
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
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Petrus-Krankenhaus
City
Wuppertal
ZIP/Postal Code
42283
Country
Germany
Facility Name
A.O.U. Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
City
Forli'
ZIP/Postal Code
47121
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico di Modena
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
Poli Univ A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Tosei General Hospital
City
Aichi, Seto
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Kurume University Hospital
City
Fukuoka, Kurume
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Sapporo Medical University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo, Himeji
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
Kanagawa Cardiovascular and Respiratory Center
City
Kanagawa, Yokohama
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Saiseikai Kumamoto Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo Chest Medical Center
City
Osaka, Sakai
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Osaka, Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Hamamatsu University Hospital
City
Shizuoka, Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima, Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Tokyo Medical and Dental University Hospital
City
Tokyo, Bunkyo-ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo, Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
JR Tokyo General Hospital
City
Tokyo, Shibuya-ku
ZIP/Postal Code
151-8528
Country
Japan
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
The Catholic University of Korea, Bucheon St.Mary's Hospital
City
Bucheon
ZIP/Postal Code
14647
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
University Clinical Center, Gdansk
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
Norbert Barlicki University Clinical Hospital No.1, Lodz
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
City
Zabrze
ZIP/Postal Code
41-803
Country
Poland
Facility Name
Res.Inst.-Compl.Iss.Cardi.Dis.
City
Kemerovo
ZIP/Postal Code
650002
Country
Russian Federation
Facility Name
Central Scientific Research Insitute of Tuberculosis
City
Moscow
ZIP/Postal Code
107564
Country
Russian Federation
Facility Name
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08026
Country
Spain
Facility Name
Hospital de Galdakao
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Facility Name
Hospital de Bellvitge
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital de Canarias
City
San Cristóbal de La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
University Hospital Llandough
City
Penarth
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Royal Stoke University Hospital
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info
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A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
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