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A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis.
Study Purpose
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
Recruitment Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not permanently discontinue study treatment - Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial - Women of childbearing potential must be ready and able 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 nintedanib treatment initiation, during the trial and for 3 months after last intake of nintedanib.
- - Further inclusion criteria apply
Exclusion Criteria:
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN) - Bilirubin > 2 x ULN - Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.
- - Clinically relevant anaemia at investigators discretion.
- - Bleeding risk, any of the following - Known genetic predisposition to bleeding according to the judgement of the investigator - Patients who require - Fibrinolysis, full-dose therapeutic anticoagulation - High dose antiplatelet therapy.
- - Hemorrhagic central nervous system (CNS) event after completion of the parent trial 1199.214/1199-0340 - Any of the following after last treatment of 1199.214/1199-0340: - Haemoptysis or haematuria - Active gastro-intestinal bleeding or Gastrointestinal (GI) - ulcers - Gastric antral vascular ectasia (GAVE) - Major injury or surgery - Coagulation parameters: International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN at Visit 1.
- - New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340: - Stroke; - Deep vein thrombosis; - Pulmonary embolism; - Myocardial infarction.
- - Major surgery performed within the next 3 months - Time period > 12 weeks between last drug intake in 1199.214 or > 1 week between last nintedanib intake in trial 1199-0340 and Visit 2 of this trial - Usage of any investigational drug after completion of 1199.214/1199-0340 or planned usage of an investigational drug during the course of this trial.
- - A disease or condition which may put the patient at risk because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the patient's ability to participate in this trial - Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial - Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03313180 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Boehringer Ingelheim |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Lung Diseases, Interstitial |
Arms
Experimental: All patients
Interventions
Drug: - Nintedanib
Administered twice daily
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Status
Active, not recruiting
Address
University of California Los Angeles
Los Angeles, California, 90095
Status
Active, not recruiting
Address
University of California Davis
Sacramento, California, 95817
Status
Active, not recruiting
Address
University of California San Francisco
San Francisco, California, 94143
Status
Completed
Address
Stanford University Medical Center
Stanford, California, 94305
Status
Active, not recruiting
Address
University of Colorado Denver
Aurora, Colorado, 80045
Status
Active, not recruiting
Address
Yale University School of Medicine
New Haven, Connecticut, 06510
Status
Active, not recruiting
Address
Georgetown University
Washington, District of Columbia, 20007
Status
Completed
Address
University of Florida College of Medicine
Jacksonville, Florida, 32209
Status
Active, not recruiting
Address
University of Miami
Miami, Florida, 33125
Status
Active, not recruiting
Address
The Emory Clinic
Atlanta, Georgia, 30322
Status
Active, not recruiting
Address
Northwestern University
Chicago, Illinois, 60611
Status
Active, not recruiting
Address
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Status
Active, not recruiting
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Active, not recruiting
Address
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Status
Active, not recruiting
Address
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Status
Active, not recruiting
Address
Boston University School of Medicine
Boston, Massachusetts, 02118
Status
Active, not recruiting
Address
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
Status
Active, not recruiting
Address
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Status
Active, not recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Active, not recruiting
Address
Hospital for Special Surgery
New York, New York, 10021
Status
Active, not recruiting
Address
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Status
Active, not recruiting
Address
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, 10032
Status
Active, not recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Active, not recruiting
Address
University of Cincinnati
Cincinnati, Ohio, 45219
Status
Active, not recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Active, not recruiting
Address
University of Toledo
Toledo, Ohio, 43614
Status
Active, not recruiting
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Active, not recruiting
Address
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Status
Completed
Address
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Status
Active, not recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Active, not recruiting
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Active, not recruiting
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Status
Active, not recruiting
Address
The University Of Texas at Houston
Houston, Texas, 77030
Status
Active, not recruiting
Address
University of Utah Health Sciences Center
Salt Lake City, Utah, 84108
Status
Active, not recruiting
Address
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Status
Active, not recruiting
Address
Virginia Mason Medical Center
Seattle, Washington, 98101
Status
Active, not recruiting
Address
University of Washington
Seattle, Washington, 98195
Status
Completed
Address
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
International Sites
Status
Active, not recruiting
Address
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, , C1426BOR
Status
Active, not recruiting
Address
APRILLUS-Asistencia e Investigación
Ciudad Autonoma Buenos Aires, , C1046AAQ
Status
Active, not recruiting
Address
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, , B1602DQD
Status
Active, not recruiting
Address
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Status
Active, not recruiting
Address
Liverpool Hospital
Sydney, New South Wales, 2170
Status
Active, not recruiting
Address
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Status
Active, not recruiting
Address
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065
Status
Active, not recruiting
Address
Medical University of Innsbruck
Innsbruck, , A-6020
Status
Active, not recruiting
Address
UNIV UZ Gent
Gent, , 9000
Status
Active, not recruiting
Address
UZ Leuven
Leuven, , 3000
Status
Active, not recruiting
Address
Centre Hospitalier Universitaire de Liège
Liège, , 4000
Status
Active, not recruiting
Address
Edumed - Educacao e Saude SA
Curitiba, , 80440-080
Status
Completed
Address
HSCM
Montreal, Quebec, H4J 1C5
Status
Active, not recruiting
Address
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, , 4070038
Status
Active, not recruiting
Address
Centro de Investigación del Maule
Talca, , 3465586
Status
Active, not recruiting
Address
Peking Union Medical College Hospital
Beijing, , 100032
Status
Active, not recruiting
Address
First Hospital of Jilin University
Changchun, , 130021
Status
Active, not recruiting
Address
West China Hospital
Chengdu, , 610041
Status
Active, not recruiting
Address
The First Affiliated Hospital of Anhui Medical University
Hefei, , 230022
Status
Active, not recruiting
Address
Huashan Hospital, Fudan University
Shanghai, , 200040
Status
Completed
Address
The First Hospital of Chinese Medical University
Shenyang, ,
Status
Active, not recruiting
Address
Institute of Rheumathology Prague
Prague, , 12850
Status
Completed
Address
Aarhus University Hospital, Skejby
Aarhus N, , 8200
Status
Active, not recruiting
Address
Odense University Hospital
Odense, , 5000 C
Status
Completed
Address
HYKS Keuhkosairauksien tutkimusyksikkö
Helsinki, , 00290
Status
Completed
Address
TYKS, Keuhkosairauksien klinikka, Turku
Turku, , 20521
Status
Active, not recruiting
Address
HOP Avicenne
Bobigny, , 93009
Status
Active, not recruiting
Address
HOP Louis Pradel
Bron, , 69677
Status
Active, not recruiting
Address
HOP Calmette
Lille, , 59037
Status
Active, not recruiting
Address
HOP Claude Huriez
Lille, , 59037
Status
Active, not recruiting
Address
HOP Arnaud de Villeneuve
Montpellier, , 34295
Status
Active, not recruiting
Address
HOP Hôtel-Dieu
Nantes, , 44000
Status
Active, not recruiting
Address
HOP Pasteur
Nice, , 06001
Status
Recruiting
Address
HOP Cochin
Paris, , 75014
Status
Active, not recruiting
Address
HOP Bichat
Paris, , 75877
Status
Active, not recruiting
Address
HOP Pontchaillou
Rennes, , 35033
Status
Active, not recruiting
Address
HOP Charles Nicolle
Rouen, , 76000
Status
Active, not recruiting
Address
HOP Larrey
Toulouse, , 31059
Status
Completed
Address
HOP Bretonneau
Tours, , 37044
Status
Active, not recruiting
Address
Klinik Donaustauf
Donaustauf, , 93093
Status
Active, not recruiting
Address
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , 01307
Status
Active, not recruiting
Address
Universitätsklinikum Erlangen
Erlangen, , 91054
Status
Active, not recruiting
Address
Universitätsmedizin Greifswald
Greifswald, , 17475
Status
Completed
Address
Asklepios Klinik Altona
Hamburg, , 22763
Status
Active, not recruiting
Address
Medizinische Hochschule Hannover
Hannover, , 30625
Status
Active, not recruiting
Address
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , 69126
Status
Completed
Address
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , 24105
Status
Active, not recruiting
Address
Universitätsklinikum Münster
Münster, , 48149
Status
Active, not recruiting
Address
Universitätsklinikum Tübingen
Tübingen, , 72076
Status
Active, not recruiting
Address
General Hospital of Athens "Laiko"
Athens, , 11527
Status
Active, not recruiting
Address
Ramaiah Medical College and Hospitals
Bangalore, , 560054
Status
Active, not recruiting
Address
Postgraduate Institute of Medical Education And Research
Chandigarh, , 160012
Status
Completed
Address
Sir Gangaram Hospital
Delhi, , 110060
Status
Completed
Address
Care Hospital
Hyderabad, , 500034
Status
Active, not recruiting
Address
Nizam's Institute of Medical Sciences
Hyderabad, , 500082
Status
Active, not recruiting
Address
Asthma Bhawan
Jaipur, , 302039
Status
Active, not recruiting
Address
Getwell Hospital & Research Institute
Nagpur, , 440012
Status
Active, not recruiting
Address
All India Institute of Medical Sciences
New Delhi, , 110029
Status
Active, not recruiting
Address
B.J. Medical College and Sasoon General Hospital
Pune, , 411001
Status
Active, not recruiting
Address
Bnei Zion Medical Center, Haifa
Haifa, , 31048
Status
Recruiting
Address
Rambam Medical Center
Haifa, , 3109601
Status
Recruiting
Address
Rabin Medical Center Beilinson
Petah Tiqwa, , 49100
Status
Active, not recruiting
Address
Sourasky Medical Center
Tel Aviv, , 64239
Status
Active, not recruiting
Address
Università degli Studi di Genova
Genova, , 16132
Status
Active, not recruiting
Address
A.O. San Gerardo di Monza
Monza, , 20900
Status
Active, not recruiting
Address
A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
Napoli, , 80138
Status
Active, not recruiting
Address
Università degli Studi Padova
Padova, , 35128
Status
Active, not recruiting
Address
Azienda Universitaria-Universita' La Sapienza
Roma, , 00161
Status
Completed
Address
Tosei General Hospital
Aichi, Seto, , 489-8642
Status
Completed
Address
Kurume University Hospital
Fukuoka, Kurume, , 830-0011
Status
Completed
Address
Sapporo Medical University Hospital
Hokkaido, Sapporo, , 060-8543
Status
Completed
Address
National Hospital Organization Himeji Medical Center
Hyogo, Himeji, , 670-8520
Status
Completed
Address
St. Marianna University School of Medicine Hospital
Kanagawa, Kawasaki, , 216-8511
Status
Completed
Address
Kitasato University Hospital
Kanagawa, Sagamihara, , 252-0375
Status
Completed
Address
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , 236-0051
Status
Completed
Address
Nagasaki University Hospital
Nagasaki, Nagasaki, , 852-8501
Status
Completed
Address
Kindai University Hospital
Osaka, Osakasayama, , 589-8511
Status
Completed
Address
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, , 591-8555
Status
Completed
Address
Osaka Medical College Hospital
Osaka, Takatsuki, , 569-8686
Status
Completed
Address
Saitama Medical University Hospital
Saitama, Iruma-gun, , 350-0495
Status
Completed
Address
Hamamatsu University Hospital
Shizuoka, Hamamatsu, , 431-3192
Status
Completed
Address
Tokushima University Hospital
Tokushima, Tokushima, , 770-8503
Status
Completed
Address
Juntendo University Hospital
Tokyo, Bunkyo-Ku, , 113-8431
Status
Completed
Address
Nippon Medical School Hospital
Tokyo, Bunkyo-Ku, , 113-8603
Status
Completed
Address
Toho University Omori Medical Center
Tokyo, Ota-ku, , 143-8541
Status
Completed
Address
Institute of Rheumatology Tokyo Women's Medical University
Tokyo, Shinjyuku-ku, , 162-0054
Status
Active, not recruiting
Address
Hospital Pulau Pinang
Georgetown Pulau Pinang, , 10990
Status
Active, not recruiting
Address
University Malaya Medical Centre
Kuala Lumpur, , 59100
Status
Active, not recruiting
Address
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Ciudad de México, , 14080
Status
Active, not recruiting
Address
Amsterdam UMC Locatie VUMC
Amsterdam, , 1081HV
Status
Completed
Address
Leids Universitair Medisch Centrum (LUMC)
Leiden, , 2333 ZA
Status
Active, not recruiting
Address
Radboud Universitair Medisch Centrum
Nijmegen, , 6525 GA
Status
Active, not recruiting
Address
Erasmus Medisch Centrum
Rotterdam, , 3015 CE
Status
Active, not recruiting
Address
Oslo Universitetssykehus HF, Rikshospitalet
Oslo, , N-0372
Status
Active, not recruiting
Address
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, , N-9038
Status
Active, not recruiting
Address
Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
Bydgoszcz, , 85168
Status
Active, not recruiting
Address
Specialist Allergy-Internist Center ALL-MED
Krakow, , 30033
Status
Active, not recruiting
Address
EMED, Center of Medical Services,Private Prac,Rzeszow
Rzeszow, , 35205
Status
Active, not recruiting
Address
Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
Wroclaw, , 50-368
Status
Active, not recruiting
Address
Hospital Garcia de Orta, EPE
Almada, , 2801-951
Status
Active, not recruiting
Address
Hospital Fernando Fonseca, EPE
Amadora, , 2720-276
Status
Active, not recruiting
Address
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , 3000-075
Status
Active, not recruiting
Address
ULSAM, EPE - Hospital Conde de Bertiandos
Ponte de Lima, , 4990-041
Status
Active, not recruiting
Address
Centro Hospitalar Universitário São João,EPE
Porto, , 4200-319
Status
Active, not recruiting
Address
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , 4434-502
Status
Active, not recruiting
Address
Hospital Santa Creu i Sant Pau
Barcelona, , 08026
Status
Active, not recruiting
Address
Hospital Vall d'Hebron
Barcelona, , 08035
Status
Completed
Address
Hospital General Universitario Gregorio Marañón
Madrid, , 28007
Status
Active, not recruiting
Address
Hospital Universitario 12 de Octubre
Madrid, , 28041
Status
Completed
Address
Hospital Dr. Peset
Valencia, , 46017
Status
Active, not recruiting
Address
Hospital Politècnic La Fe
Valencia, , 46026
Status
Active, not recruiting
Address
Hospital Álvaro Cunqueiro
Vigo, , 36312
Status
Active, not recruiting
Address
Clinical Rheumatology Research Center Sahlgrenska
Gothenburg, , 413 45
Status
Active, not recruiting
Address
Universitätsspital Zürich
Zürich, , 8091
Status
Active, not recruiting
Address
Ramathibodi Hospital
Bangkok, , 10400
Status
Active, not recruiting
Address
Srinagarind Hospital
Muang, , 40002
Status
Active, not recruiting
Address
Songklanagarind Hospital
Songkhla, , 90110
Status
Active, not recruiting
Address
Royal Free Hospital
London, , NW3 2QG
Status
Active, not recruiting
Address
Guy's Hospital
London, , SE1 9RT
Status
Active, not recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP
Status
Active, not recruiting
Address
Salford Royal Hospital
Salford, , M6 8HD
