Clinical trial NCT03820726: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-01-29
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

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