Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619085
• Other study ID #: 1199.33
• Secondary ID: 2011-002766-21
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2012
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 752
• Est. completion date: February 1, 2021
• Est. primary completion date: July 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

1. Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.

2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

Exclusion criteria:

1. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper Limit of Normal (ULN) (Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible)

2. Bilirubin > 1.5 fold ULN

3. Bleeding risk

4. Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.

5. New major thrombo-embolic events developed after completion of the parent trial.

6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.

7. Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial.

8. A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial.

9. Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.

10. Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Nintedanib
Nintedanib twice a day

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Repatriation General Hospital	Concord	New South Wales
Australia	Frankston Hospital	Frankston	Victoria
Australia	Alfred Hospital	Melbourne	Victoria
Belgium	Brussels - UNIV UZ Brussel	Brussel
Belgium	ULB Hopital Erasme	Bruxelles
Belgium	UZ Leuven	Leuven
Belgium	Yvoir - UNIV UCL de Mont-Godinne	Yvoir
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Chile	Instituto Nacional del Tórax	Santiago de Chile
China	Beijing Friendship Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Xiangya Hospital, Central South University	Changsha
China	West China Hospital	Chengdu
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	Shanghai Pulmonary Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	General Hospital of Shenyang Military Region	Shenyang
China	Xijing Hospital	Xi'An
China	General Hospital of Ningxia Medical University	Yinchuan
Czechia	Thomayer Hospital	Prague 4
Czechia	University Hospital Na Bulovce, Prague	Prague 8
Czechia	Masaryk Hospital, Usti nad Labem	Usti nad Labem
Finland	HYKS Keuhkosairauksien tutkimusyksikkö	Helsinki
Finland	Mehiläinen Kielotie, Vantaa	Vantaa
France	HOP Avicenne	Bobigny
France	HOP Bocage	Dijon
France	HOP Calmette	Lille Cedex
France	HOP Louis Pradel	Lyon cedex
France	HOP Nord	Marseille
France	HOP Arnaud de Villeneuve	Montpellier
France	HOP Pasteur	Nice
France	HOP Bichat	Paris
France	HOP Européen G. Pompidou	Paris
France	HOP Tenon	Paris
France	HOP Maison Blanche	Reims
France	HOP Pontchaillou	Rennes Cedex 9
France	HOP Larrey	Toulouse
Germany	CIMS Studienzentrum Bamberg GmbH	Bamberg
Germany	Helios Klinikum Emil von Behring	Berlin
Germany	Evangelische Lungenklinik Berlin	Berlin-Buch
Germany	Universitätsklinikum Carl Gustav Carus Dresden	Coswig
Germany	Klinik Donaustauf	Donaustauf
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Universitätsklinikum Freiburg	Freiburg/Breisgau
Germany	Universitätsklinikum Gießen und Marburg GmbH	Gießen
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH	Grosshansdorf
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Klinikum der Universität München - Campus Großhadern	München
Germany	Universitätsklinikum Münster	Münster
Greece	Athens Hospital of Chest Diseases "Sotiria"	Athens
Greece	University Hospital of Heraklion, University Pulmonology Cl	Heraklion
Greece	General University Hospital of Larissa	Larisa
India	Mehta Hospital & Cardiopulmonary Care Centre	Ahmedabad
India	Chest & Maternity Center	Bangalore
India	Asthma Bhawan	Jaipur
India	National Allergy Asthma Bronchitis Institute, Kolkata	Kolkatta
India	P.D. Hinduja National Hospital	Mumbai
India	Jahingir Clinical Development Centre	Pune
Ireland	Mater Misericordiae University Hospital	Dublin
Israel	Rabin Medical Center Beilinson	Petah Tiqwa
Israel	Kaplan Medical Center	Rehovot
Italy	Osp. Clin. SS. Anunziata	Chieti Scalo
Italy	Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli	Forli'
Italy	Osp. S. Giuseppe Fatebenefratelli	Milano
Italy	Università di Modena e Reggio Emilia	Modena
Italy	A.O. San Gerardo di Monza	Monza
Italy	Università Federico II	Napoli
Italy	Università degli Studi Padova	Padova
Italy	Ospedale di Cisanello	Pisa
Italy	Ospedale di Cisanello	Pisa
Italy	Pol. Universitario Tor Vergata	Roma
Italy	A.O.U. Senese Policlinico Santa Maria alle Scotte	Siena
Japan	Nagoya University Hospital	Aichi, Nagoya
Japan	Tosei General Hospital	Aichi, Seto
Japan	Ogaki Municipal Hospital	Gifu, Ogaki
Japan	National Hospital Organization Himeji Medical Center	Himeji, Hyogo
Japan	Kobe City Medical Center General Hospital	Hyogo, Kobe
Japan	Ibarakihigashi National Hospial	Ibaraki, Naka-gun
Japan	Toranomon Hospital Kajigaya	Kanagawa, Kawasaki
Japan	Kanagawa Cardiovascular and Respiratory Center	Kanagawa, Yokohama
Japan	Tohoku University Hospital	Miyagi, Sendai
Japan	Tenri Hospital	Nara, Tenri
Japan	Kindai University Hospital	Osaka, Osaka-sayama
Japan	Saitama Cardiovascular and Respiratory Center	Saitama, Kumagaya
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai, Osaka
Japan	Jichi Medical University Hospital	Tochigi, Shimotsuke
Japan	Tokushima University Hospital	Tokushima, Tokushima
Japan	Nippon Medical School Hospital	Tokyo, Bunkyo-ku
Japan	Tokyo Medical and Dental University	Tokyo, Bunkyo-ku
Japan	Fukujuji Hospital	Tokyo, Kiyose
Japan	The Jikei University Hospital	Tokyo, Minato-ku
Japan	Toranomon Hospital	Tokyo, Minato-ku
Japan	Toho University Omori Medical Center	Tokyo, Ota-ku
Japan	JR Tokyo General Hospital	Tokyo, Shibuya-ku
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo, Shinjuku-ku
Japan	Tokyo Medical University Hospital	Tokyo, Shinjuku-ku
Japan	Tottori University Hospital	Tottori, Yonago
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital Seoul	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St.Mary's Hospital	Seoul
Mexico	Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas	Mexico DF
Netherlands	OLVG, locatie Oosterpark	Amsterdam
Netherlands	St. Antonius ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Erasmus Medisch Centrum	Rotterdam
Portugal	CHUC - Centro Hospitalar e Universitário de Coimbra, EPE	Coimbra
Portugal	Centro Hospitalar Lisboa Norte Hospital Pulido Valente	Lisboa
Portugal	CHLC, EPE - Hospital de Santa Marta	Lisboa
Portugal	Centro Hospitalar Universitário São João,EPE	Porto
Portugal	Centro Hospitalar de Vila Nova de Gaia	Vila Nova de Gaia
Russian Federation	Scientific Research Institute of Pulmonology	St. Petersburg
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital de Bellvitge	L´Hospitalet de Llobregat
Spain	Hospital Nuestra Señora de Valme	Sevilla
Turkey	Ankara Universitesi Tip Fakultesi	Ankara
Turkey	Istanbul Universitesi Cerrahpasa Tip Fakultesi	Istanbul
Turkey	Yedikule Gog. Hst. EAH	Istanbul
Turkey	Dr.Suat Seren EAH	Izmir
Turkey	Ege Universitesi T.F.	Izmir
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	St James's University Hospital	Leeds
United Kingdom	Aintree University Hospital	Liverpool
United Kingdom	Royal Brompton Hospital	London
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Southmead Hospital	Westbury On Trym
United States	Pulmonary and Critical Care Associates	Albany	New York
United States	Georgia Clinical Research	Austell	Georgia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Lung Research Center, LLC	Chesterfield	Missouri
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Vermont Lung Center	Colchester	Vermont
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Western Connecticut Medical Group	Danbury	Connecticut
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Jasper Summit Research, LLC	Jasper	Alabama
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Baptist Health Lexington	Lexington	Kentucky
United States	DCOL Center for Clinical Research	Longview	Texas
United States	University of California	Los Angeles	California
United States	Lynchburg Pulmonary Associates	Lynchburg	Virginia
United States	University of Wisconsin	Madison	Wisconsin
United States	Metroplex Pul and Sleep Ctr	McKinney	Texas
United States	Minnesota Lung Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	New York Presbyterian Hospital	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pulmonary Associates	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	The Oregon Clinic	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Diagnostics Research Group	San Antonio	Texas
United States	University of California	San Francisco	California
United States	Sansum Clinic	Santa Barbara	California
United States	FDC Seifer PLC Pulmonary	Shelbyville	Tennessee
United States	Pulmonary Assoc of Stamford	Stamford	Connecticut
United States	Stanford University Medical Center	Stanford	California
United States	ID Clinical Research, LTD	Toledo	Ohio
United States	University of California	Torrance	California
United States	Cleveland Clinic	Weston	Florida
United States	Via Christi Clinic, PA	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Chile,  China,  Czechia,  Finland,  France,  Germany,  Greece,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Portugal,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.	From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.

External Links

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