A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

444

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

January 25, 2023

Study Completion Date

January 25, 2023

Conditions
Lung Diseases, Interstitial
Interventions
DRUG

Nintedanib

Administered twice daily

Trial Locations (159)

2050

Royal Prince Alfred Hospital, Camperdown

2170

Liverpool Hospital, Sydney

3000

UZ Leuven, Leuven

3065

St Vincent's Hospital Melbourne, Fitzroy

4000

Centre Hospitalier Universitaire de Liège, Liège

5000

Royal Adelaide Hospital, Adelaide

8091

University Hospital Zurich, Zurich

8200

Aarhus University Hospital, Aarhus N

9000

UNIV UZ Gent, Ghent

10021

Hospital for Special Surgery, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center-New York Presbyterian Hospital, New York

10400

Ramathibodi Hospital, Bangkok

10990

Hospital Pulau Pinang, Georgetown Pulau Pinang

11527

"General Hospital of Athens Laiko", Athens

12850

Institute of Rheumathology Prague, Prague

14080

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas, Mexico City

16132

Università degli Studi di Genova, Genova

17475

Universitätsmedizin Greifswald, Greifswald

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

19140

Temple University Hospital, Philadelphia

20007

Georgetown University, Washington D.C.

20521

TYKS, Turku

20900

A.O. San Gerardo di Monza, Monza

21224

Johns Hopkins Hospital, Baltimore

22042

Inova Fairfax Medical Campus, Falls Church

22763

Asklepios Klinik Altona, Hamburg

24105

Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel

27710

Duke University Medical Center, Durham

28007

Hospital General Universitario Gregorio Marañón, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29425

Medical University of South Carolina, Charleston

30033

Specialist Allergy-Internist Center ALL-MED, Krakow

30322

The Emory Clinic, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31048

Bnei Zion Medical Center, Haifa, Haifa

31059

HOP Larrey, Toulouse

32209

University of Florida College of Medicine, Jacksonville

33125

University of Miami, Miami

34295

HOP Arnaud de Villeneuve, Montpellier

35033

HOP Pontchaillou, Rennes

35128

Università degli Studi Padova, Padua

35205

EMED, Center of Medical Services,Private Prac,Rzeszow, Rzeszów

35233

University of Alabama at Birmingham, Birmingham

36312

Hospital Álvaro Cunqueiro, Vigo

37044

HOP Bretonneau, Tours

37204

Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks, Nashville

40002

Srinagarind Hospital, Muang

43614

University of Toledo, Toledo

44093

HOP Hôtel-Dieu, Nantes

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati, Cincinnati

46017

Hospital Dr. Peset, Valencia

46026

Hospital Politècnic La Fe, Valencia

48149

Universitätsklinikum Münster, Münster

49100

Rabin Medical Center Beilinson, Petah Tikva

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Froedtert and The Medical College of Wisconsin, Milwaukee

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester, Rochester

59037

CHRU Lille, Lille

HOP Claude Huriez, Lille

59100

University of Malaya Medical Centre, Kuala Lumpur

60611

Northwestern University, Chicago

63110

Washington University School of Medicine, St Louis

64239

Sourasky Medical Center, Tel Aviv

66160

University of Kansas Medical Center, Kansas City

69126

Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg, Heidelberg

69677

HOP Louis Pradel, Bron

70112

Tulane University Hospital and Clinic, New Orleans

72076

Universitätsklinikum Tübingen, Tübingen

75390

University of Texas Southwestern Medical Center, Dallas

75877

HOP Bichat, Paris

76000

HOP Charles Nicolle, Rouen

77030

The University of Texas Health Science Center at Houston, Houston

80045

University of Colorado Denver, Aurora

80138

A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli, Napoli

84108

University of Utah Health Sciences Center, Salt Lake City

85168

Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz, Bydgoszcz

90095

University of California Los Angeles, Los Angeles

90110

Songklanagarind Hospital, Songkhla

91054

Universitätsklinikum Erlangen, Erlangen

93009

HOP Avicenne, Bobigny

93093

Klinik Donaustauf, Donaustauf

94143

University of California San Francisco, San Francisco

94305

Stanford University Medical Center, Stanford

95817

University of California Davis, Sacramento

98101

Virginia Mason Medical Center, Seattle

98195

University of Washington, Seattle

100032

Peking Union Medical College Hospital, Beijing

110001

The First Hospital of China Medical University, Shenyang

110029

All India Institute of Medical Sciences, New Delhi

110060

Sir Gangaram Hospital, Delhi

130021

The First Hospital of Jilin University, Changchun

160012

Post Graduate Institute of Medical Education and Research, Chandigarh

200040

Huashan Hospital, Fudan University, Shanghai

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

302039

Asthma Bhawan, Jaipur

411001

B.J. Medical College and Sasoon General Hospital, Pune

440012

Getwell Hospital & Research Institute, Nagpur

500034

Care Hospital, Hyderabad

500082

Nizam's Institute of Medical Sciences, Hyderabad

560054

Ramaiah Medical College and Hospitals, Bangalore

610041

West China Hospital, Chengdu

3109601

Rambam Medical Center, Haifa

3465586

Centro de Investigación del Maule, Talca

4070038

"Hospital Clínico Reg. de Concepción Dr. G. Grant Benavente", Concepción

06510

Yale University School of Medicine, New Haven

02118

Boston University School of Medicine, Boston

C1426BOR

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich, Buenos Aires

C1046AAQ

APRILLUS-Asistencia e Investigación, Ciudad Autonoma Buenos Aires

B1602DQD

CEMER-Centro Medico De Enfermedades Respiratorias, Florida

A-6020

Medical University of Innsbruck, Innsbruck

80440-080

Edumed - Educacao e Saude SA, Curitiba

H4J 1C5

HSCM, Montreal

5000 C

Odense University Hospital, Odense

00290

HYKS Keuhkosairauksien tutkimusyksikkö, Helsinki

06001

HOP Pasteur, Nice

01307

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

00161

Azienda Universitaria-Universita' La Sapienza, Roma

489-8642

Tosei General Hospital, Aichi, Seto

830-0011

Kurume University Hospital, Fukuoka, Kurume

060-8543

Sapporo Medical University Hospital, Hokkaido, Sapporo

670-8520

National Hospital Organization Himeji Medical Center, Hyogo, Himeji

216-8511

St. Marianna University Hospital, Kanagawa, Kawasaki

252-0375

Kitasato University Hospital, Kanagawa, Sagamihara

236-0051

Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Yokohama

852-8501

Nagasaki University Hospital, Nagasaki, Nagasaki

589-8511

Kindai University Hospital, Osaka, Osakasayama

591-8555

National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Sakai

569-8686

Osaka Medical College Hospital, Osaka, Takatsuki

350-0495

Saitama Medical University Hospital, Saitama, Iruma-gun

431-3192

Hamamatsu University Hospital, Shizuoka, Hamamatsu

770-8503

Tokushima University Hospital, Tokushima, Tokushima

113-8431

Juntendo University Hospital, Tokyo, Bunkyo-Ku

113-8603

Nippon Medical School Hospital, Tokyo, Bunkyo-Ku

143-8541

Toho University Omori Medical Center, Tokyo, Ota-ku

162-0054

Institute of Rheumatology Tokyo Women's Medical University, Tokyo, Shinjyuku-ku

1081HV

Amsterdam UMC Locatie VUMC, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum (LUMC), Leiden

6525 GA

Radboud Universitair Medisch Centrum, Nijmegen

3015 CE

Erasmus Medisch Centrum, Rotterdam

N-0372

Oslo Universitetssykehus HF, Rikshospitalet, Oslo

N-9038

Universitetssykehuset Nord-Norge, Tromsø, Tromsø

50-368

Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw, Wroclaw

2801-951

Hospital Garcia de Orta, EPE, Almada

2720-276

Hospital Fernando Fonseca, EPE, Amadora

3000-075

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra

4990-041

ULSAM, EPE - Hospital Conde de Bertiandos, Ponte de Lima

4200-319

Centro Hospitalar Universitário São João,EPE, Porto

4434-502

Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia

08026

Hospital Santa Creu i Sant Pau, Barcelona

08035

Hospital Vall d'Hebron, Barcelona

413 45

Clinical Rheumatology Research Center Sahlgrenska, Gothenburg

NW3 2QG

Royal Free Hospital, London

SE1 9RT

Guy's Hospital, London

SW3 6NP

Royal Brompton Hospital, London

M6 8HD

Salford Royal Hospital, Salford

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY

NCT03313180 - A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis | Biotech Hunter | Biotech Hunter