A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Lung Diseases, Interstitial Clinical Trial

Official title:

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820726
• Other study ID #: 1199-0248
• Secondary ID: 2018-000525-32
• Status: Completed
• Phase: Phase 3
• Start date: April 16, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Drug:
• Nintedanib
Bid

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Chile,  China,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Adverse Events	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.	From first nintedanib intake until last nintedanib intake + 28 days of Residual effect period (REP), up to 1195 days.

External Links

•   Related Info