Learn about Research & Clinical Trials
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Study Purpose
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).
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:
- - 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.
Exclusion Criteria:
- - Any disease that may put the patient at risk when participating in this trial.
- - 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.
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. |
NCT03820726 |
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, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Lung Diseases, Interstitial |
Study Website: | View Trial Website |
Arms
Experimental: All subjects
Interventions
Drug: - Nintedanib
Bid
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
Completed
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Status
Active, not recruiting
Address
University of California Los Angeles
Los Angeles, California, 90095
Status
Completed
Address
University of California Davis
Sacramento, California, 95817
Status
Active, not recruiting
Address
National Jewish Health
Denver, Colorado, 80206
Status
Active, not recruiting
Address
Yale University School of Medicine
New Haven, Connecticut, 06510
Status
Active, not recruiting
Address
Pulmonary and Sleep of Tampa Bay
Brandon, Florida, 33511
Status
Active, not recruiting
Address
University of Florida College of Medicine
Jacksonville, Florida, 32209
Status
Completed
Address
Emory University
Atlanta, Georgia, 30322
Status
Completed
Address
University of Chicago
Chicago, Illinois, 60637
Status
Completed
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Completed
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Active, not recruiting
Address
Johns Hopkins Hospital
Baltimore, Maryland, 21224
Status
Completed
Address
Pulmonary and Critical Care Associates of Baltimore
Towson, Maryland, 21286
Status
Active, not recruiting
Address
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Status
Active, not recruiting
Address
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Status
Completed
Address
Henry Ford Health System
Detroit, Michigan, 48202
Status
Completed
Address
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Status
Completed
Address
The Lung Research Center, LLC
Chesterfield, Missouri, 63017
Status
Completed
Address
Creighton University
Omaha, Nebraska, 68124
Status
Active, not recruiting
Address
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Status
Completed
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
Completed
Address
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
Status
Active, not recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27710
Status
Active, not recruiting
Address
The Oregon Clinic
Portland, Oregon, 97220
Status
Completed
Address
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Status
Completed
Address
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Status
Completed
Address
Baylor University Medical Center
Dallas, Texas, 75246
Status
Active, not recruiting
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Status
Completed
Address
Diagnostics Research Group
San Antonio, Texas, 78229
Status
Completed
Address
Medical Arts and Research Center (MARC)
San Antonio, Texas, 78229
Status
Completed
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
International Sites
Status
Active, not recruiting
Address
Centro Dr. Lazaro Langer S.R.L
Alberdi Sur, , X5003DCE
Status
Active, not recruiting
Address
Centro de Investigaciones Metabólicas (CINME)
C.a.b.a, , 1056
Status
Active, not recruiting
Address
CEMER-Centro Medico De Enfermedades Respiratorias
Florida, , B1602DQD
Status
Active, not recruiting
Address
INSARES
Mendoza, , M5500CCG
Status
Active, not recruiting
Address
Instituto Médico de la Fundación Estudios Clínicos
Rosario, , S2000DEJ
Status
Completed
Address
ULB Hopital Erasme
Bruxelles, , 1070
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
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, , 5530
Status
Completed
Address
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Status
Active, not recruiting
Address
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Status
Active, not recruiting
Address
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Status
Active, not recruiting
Address
CHUS Fleurimont
Sherbrooke, Quebec, J1H 5N4
Status
Active, not recruiting
Address
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
Concepción, , 4070038
Status
Active, not recruiting
Address
Instituto Nacional del Tórax
Providencia, Santiago De Chile, , 7500691
Status
Active, not recruiting
Address
Centro de Investigación del Maule
Talca, , 3465586
Status
Active, not recruiting
Address
Peking Union Medical College Hospital
Beijing, , 100730
Status
Active, not recruiting
Address
Nanjing Drum Tower Hospital
Nanjing, , 210008
Status
Active, not recruiting
Address
The First Hospital of Chinese Medical University
Shenyang, , 110001
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 Côte de Nacre
Caen, , 14033
Status
Active, not recruiting
Address
CHRU Lille
Lille, , 59037
Status
Active, not recruiting
Address
HOP Nord
Marseille, , 13915
Status
Active, not recruiting
Address
HOP Arnaud de Villeneuve
Montpellier, , 34295
Status
Completed
Address
HOP Pasteur
Nice, , 06001
Status
Active, not recruiting
Address
HOP Bichat
Paris, , 75018
Status
Active, not recruiting
Address
HOP Maison Blanche
Reims, , 51092
Status
Active, not recruiting
Address
HOP Pontchaillou
Rennes, , 35033
Status
Completed
Address
HOP Civil
Strasbourg, , 67091
Status
Active, not recruiting
Address
HOP Bretonneau
Tours, , 37044
Status
Completed
Address
Universitätsklinikum Bonn AöR
Bonn, , 53105
Status
Active, not recruiting
Address
Fachkrankenhaus Coswig GmbH
Coswig, , 01640
Status
Completed
Address
Klinik Donaustauf
Donaustauf, , 93093
Status
Completed
Address
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , 45239
Status
Completed
Address
Medizinische Hochschule Hannover
Hannover, , 30625
Status
Completed
Address
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
Heidelberg, , 69126
Status
Completed
Address
Petrus-Krankenhaus
Wuppertal, , 42283
Status
Active, not recruiting
Address
A.O.U. Policlinico Vittorio Emanuele
Catania, , 95124
Status
Active, not recruiting
Address
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
FORLì, , 47121
Status
Active, not recruiting
Address
Azienda Ospedaliera Policlinico di Modena
Modena, , 41100
Status
Active, not recruiting
Address
A.O. San Gerardo di Monza
Monza, , 20052
Status
Active, not recruiting
Address
Policlinico Gemelli
Roma, , 00168
Status
Active, not recruiting
Address
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , 53100
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
Kobe City Medical Center General Hospital
Hyogo, Kobe, , 650-0047
Status
Completed
Address
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, , 319-1113
Status
Completed
Address
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, , 236-0051
Status
Completed
Address
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, , 861-4193
Status
Completed
Address
Tohoku University Hospital
Miyagi, Sendai, , 980-8574
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
Hamamatsu University Hospital
Shizuoka, Hamamatsu, , 431-3192
Status
Completed
Address
Tokushima University Hospital
Tokushima, Tokushima, , 770-8503
Status
Completed
Address
Tokyo Medical and Dental University
Tokyo, Bunkyo-ku, , 113-8519
Status
Completed
Address
Toranomon Hospital
Tokyo, Minato-ku, , 105-8470
Status
Completed
Address
JR Tokyo General Hospital
Tokyo, Shibuya-ku, , 151-8528
Status
Completed
Address
Center Hospital of the National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, , 162-8655
Status
Active, not recruiting
Address
The Catholic University of Korea, Bucheon St.Mary's Hospital
Bucheon, , 14647
Status
Active, not recruiting
Address
Seoul National University Bundang Hospital
Seongnam, , 13620
Status
Active, not recruiting
Address
Asan Medical Center
Seoul, , 05505
Status
Active, not recruiting
Address
University Clinical Center, Gdansk
Gdansk, , 80-214
Status
Active, not recruiting
Address
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
Katowice, , 40-752
Status
Active, not recruiting
Address
Norbert Barlicki University Clinical Hospital No.1, Lodz
Lodz, , 90-153
Status
Active, not recruiting
Address
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
Warszawa, , 01-138
Status
Active, not recruiting
Address
Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
Zabrze, , 41-803
Status
Active, not recruiting
Address
Res.Inst.-Compl.Iss.Cardi.Dis.
Kemerovo, , 650002
Status
Active, not recruiting
Address
Central Scientific Research Insitute of Tuberculosis
Moscow, , 107564
Status
Active, not recruiting
Address
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
Moscow, , 119992
Status
Active, not recruiting
Address
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
St. Petersburg, , 197022
Status
Active, not recruiting
Address
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
Yaroslavl, , 150003
Status
Active, not recruiting
Address
Hospital Santa Creu i Sant Pau
Barcelona, , 08026
Status
Active, not recruiting
Address
Hospital de Galdakao
Galdakao, , 48960
Status
Recruiting
Address
Hospital de Bellvitge
L'Hospitalet de Llobregat, , 08907
Status
Active, not recruiting
Address
Hospital La Princesa
Madrid, , 28006
Status
Active, not recruiting
Address
Hospital Central de Asturias
Oviedo, , 33011
Status
Completed
Address
Hospital Son Espases
Palma de Mallorca, , 07120
Status
Completed
Address
Hospital de Canarias
San Cristóbal de La Laguna, , 38320
Status
Active, not recruiting
Address
Hospital Virgen del Rocío
Sevilla, , 41013
Status
Active, not recruiting
Address
Royal Infirmary of Edinburgh
Edinburgh, , EH16 4SA
Status
Active, not recruiting
Address
St James's University Hospital
Leeds, , LS9 7TF
Status
Active, not recruiting
Address
Royal Brompton Hospital
London, , SW3 6NP
Status
Active, not recruiting
Address
Wythenshawe Hospital
Manchester, , M23 9LT
Status
Completed
Address
University Hospital Llandough
Penarth, , CF64 2XX
Status
Active, not recruiting
Address
Royal Stoke University Hospital
Stoke-on-Trent, , ST4 6QG