A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
- Registration Number
- NCT03820726
- Lead Sponsor
- Boehringer Ingelheim
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 435
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nintedanib Nintedanib 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Any Adverse Events From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days. 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
Name Time Method
Trial Locations
- Locations (121)
National Hospital Organization Himeji Medical Center
🇯🇵Hyogo, Himeji, Japan
HOP Civil
🇫🇷Strasbourg, France
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
🇷🇺St. Petersburg, Russian Federation
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom
HOP Pasteur
🇫🇷Nice, France
HOP Nord
🇫🇷Marseille, France
Winnipeg Clinic
🇨🇦Winnipeg, Manitoba, Canada
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Medical Arts and Research Center (MARC)
🇺🇸San Antonio, Texas, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
A.O.U. Policlinico Vittorio Emanuele
🇮🇹Catania, Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
Poli Univ A. Gemelli
🇮🇹Roma, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
University of California Davis
🇺🇸Sacramento, California, United States
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Creighton University
🇺🇸Omaha, Nebraska, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Florida College of Medicine
🇺🇸Jacksonville, Florida, United States
Pulmonary and Sleep of Tampa Bay
🇺🇸Brandon, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Pulmonary and Critical Care Associates of Baltimore
🇺🇸Towson, Maryland, United States
The Lung Research Center, LLC
🇺🇸Chesterfield, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
The Oregon Clinic
🇺🇸Portland, Oregon, United States
NewYork-Presbyterian/Weill Cornell Medical Center
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Centro Dr. Lazaro Langer S.R.L
🇦🇷Alberdi Sur, Argentina
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
CEMER-Centro Medico De Enfermedades Respiratorias
🇦🇷Florida, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷C.a.b.a, Argentina
INSARES
🇦🇷Mendoza, Argentina
Instituto Médico de la Fundación Estudios Clínicos
🇦🇷Rosario, Argentina
UZ Leuven
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium
Yvoir - UNIV UCL de Mont-Godinne
🇧🇪Yvoir, Belgium
ULB Hopital Erasme
🇧🇪Bruxelles, Belgium
Peking Union Medical College Hospital
🇨🇳Beijing, China
CHUS Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
🇨🇱Concepción, Chile
Centro de Investigación del Maule
🇨🇱Talca, Chile
Instituto Nacional del Tórax
🇨🇱Providencia, Santiago De Chile, Chile
HOP Louis Pradel
🇫🇷Bron, France
HOP Bretonneau
🇫🇷Tours, France
The First Hospital of China Medical University
🇨🇳Shenyang, China
HOP Côte de Nacre
🇫🇷Caen, France
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China
HOP Avicenne
🇫🇷Bobigny, France
CHRU Lille
🇫🇷Lille, France
HOP Arnaud de Villeneuve
🇫🇷Montpellier, France
HOP Bichat
🇫🇷Paris, France
HOP Pontchaillou
🇫🇷Rennes, France
HOP Maison Blanche
🇫🇷Reims, France
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Fachkrankenhaus Coswig GmbH
🇩🇪Coswig, Germany
Klinik Donaustauf
🇩🇪Donaustauf, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
🇩🇪Essen, Germany
Petrus-Krankenhaus
🇩🇪Wuppertal, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
A.O. San Gerardo di Monza
🇮🇹Monza, Italy
Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
🇮🇹Forli', Italy
Azienda Ospedaliera Policlinico di Modena
🇮🇹Modena, Italy
Tosei General Hospital
🇯🇵Aichi, Seto, Japan
Sapporo Medical University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Kurume University Hospital
🇯🇵Fukuoka, Kurume, Japan
Kobe City Medical Center General Hospital
🇯🇵Hyogo, Kobe, Japan
Ibarakihigashi National Hospial
🇯🇵Ibaraki, Naka-gun, Japan
Kanagawa Cardiovascular and Respiratory Center
🇯🇵Kanagawa, Yokohama, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto, Kumamoto, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
🇯🇵Osaka, Sakai, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai, Japan
Osaka Medical College Hospital
🇯🇵Osaka, Takatsuki, Japan
Hamamatsu University Hospital
🇯🇵Shizuoka, Hamamatsu, Japan
Tokushima University Hospital
🇯🇵Tokushima, Tokushima, Japan
Tokyo Medical and Dental University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
JR Tokyo General Hospital
🇯🇵Tokyo, Shibuya-ku, Japan
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Tokyo, Shinjuku-ku, Japan
Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.
🇵🇱Katowice, Poland
Central Scientific Research Insitute of Tuberculosis
🇷🇺Moscow, Russian Federation
Norbert Barlicki University Clinical Hospital No.1, Lodz
🇵🇱Lodz, Poland
The Catholic University of Korea, Bucheon St.Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa
🇵🇱Warszawa, Poland
Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA
🇵🇱Zabrze, Poland
Res.Inst.-Compl.Iss.Cardi.Dis.
🇷🇺Kemerovo, Russian Federation
Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl
🇷🇺Yaroslavl, Russian Federation
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital de Canarias
🇪🇸San Cristóbal de La Laguna, Spain
Hospital La Princesa
🇪🇸Madrid, Spain
Hospital de Galdakao
🇪🇸Galdakao, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain
Hospital Son Espases
🇪🇸Palma de Mallorca, Spain
St James's University Hospital
🇬🇧Leeds, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
University Hospital Llandough
🇬🇧Penarth, United Kingdom
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Toranomon Hospital
🇯🇵Tokyo, Minato-ku, Japan
Moscow 1st State Med.Univ.n.a.I.M.Sechenov
🇷🇺Moscow, Russian Federation
Royal Brompton Hospital
🇬🇧London, United Kingdom
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada