Clinical trial NCT01619085: Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Official title: An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-06-14
Enrollment: 752
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Jasper
country: United States
facility: Jasper Summit Research, LLC
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Los Angeles
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: Santa Barbara
country: United States
facility: Sansum Clinic
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Torrance
country: United States
facility: University of California
state: California
city: Danbury
country: United States
facility: Western Connecticut Medical Group
state: Connecticut
city: Stamford
country: United States
facility: Pulmonary Assoc of Stamford
state: Connecticut
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Austell
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Wichita
country: United States
facility: Via Christi Clinic, PA
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Minneapolis
country: United States
facility: Minnesota Lung Center
state: Minnesota
city: Chesterfield
country: United States
facility: The Lung Research Center, LLC
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Pulmonary and Critical Care Associates
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Toledo
country: United States
facility: ID Clinical Research, LTD
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Shelbyville
country: United States
facility: FDC Seifer PLC Pulmonary
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: McKinney
country: United States
facility: Metroplex Pul and Sleep Ctr
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Colchester
country: United States
facility: Vermont Lung Center
state: Vermont
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Lynchburg
country: United States
facility: Lynchburg Pulmonary Associates
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Repatriation General Hospital
state: New South Wales
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Brussel
country: Belgium
facility: Brussels - UNIV UZ Brussel
city: Bruxelles
country: Belgium
facility: ULB Hopital Erasme
city: Leuven
country: Belgium
facility: UZ Leuven
city: Yvoir
country: Belgium
facility: Yvoir - UNIV UCL de Mont-Godinne
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Santiago de Chile
country: Chile
facility: Instituto Nacional del Tórax
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Chengdu
country: China
facility: West China Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
city: Xi'An
country: China
facility: Xijing Hospital
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Prague 4
country: Czechia
facility: Thomayer Hospital
city: Prague 8
country: Czechia
facility: University Hospital Na Bulovce, Prague
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital, Usti nad Labem
city: Helsinki
country: Finland
facility: HYKS Keuhkosairauksien tutkimusyksikkö
city: Vantaa
country: Finland
facility: Mehiläinen Kielotie, Vantaa
city: Bobigny
country: France
facility: HOP Avicenne
city: Dijon
country: France
facility: HOP Bocage
city: Lille Cedex
country: France
facility: HOP Calmette
city: Lyon cedex
country: France
facility: HOP Louis Pradel
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 Européen G. Pompidou
city: Paris
country: France
facility: HOP Bichat
city: Paris
country: France
facility: HOP Tenon
city: Reims
country: France
facility: HOP Maison Blanche
city: Rennes Cedex 9
country: France
facility: HOP Pontchaillou
city: Toulouse
country: France
facility: HOP Larrey
city: Bamberg
country: Germany
facility: CIMS Studienzentrum Bamberg GmbH
city: Berlin-Buch
country: Germany
facility: Evangelische Lungenklinik Berlin
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring
city: Coswig
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Donaustauf
country: Germany
facility: Klinik Donaustauf
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Freiburg/Breisgau
country: Germany
facility: Universitätsklinikum Freiburg
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Grosshansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: München
country: Germany
facility: Klinikum der Universität München - Campus Großhadern
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Athens
country: Greece
facility: Athens Hospital of Chest Diseases "Sotiria"
city: Heraklion
country: Greece
facility: University Hospital of Heraklion, University Pulmonology Cl
city: Larisa
country: Greece
facility: General University Hospital of Larissa
city: Ahmedabad
country: India
facility: Mehta Hospital & Cardiopulmonary Care Centre
city: Bangalore
country: India
facility: Chest & Maternity Center
city: Jaipur
country: India
facility: Asthma Bhawan
city: Kolkatta
country: India
facility: National Allergy Asthma Bronchitis Institute, Kolkata
city: Mumbai
country: India
facility: P.D. Hinduja National Hospital
city: Pune
country: India
facility: Jahingir Clinical Development Centre
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center Beilinson
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Chieti Scalo
country: Italy
facility: Osp. Clin. SS. Anunziata
city: Forli'
country: Italy
facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli
city: Milano
country: Italy
facility: Osp. S. Giuseppe Fatebenefratelli
city: Modena
country: Italy
facility: Università di Modena e Reggio Emilia
city: Monza
country: Italy
facility: A.O. San Gerardo di Monza
city: Napoli
country: Italy
facility: Università Federico II
city: Padova
country: Italy
facility: Università degli Studi Padova
city: Pisa
country: Italy
facility: Ospedale di Cisanello
city: Pisa
country: Italy
facility: Ospedale di Cisanello
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Aichi, Nagoya
country: Japan
facility: Nagoya University Hospital
city: Aichi, Seto
country: Japan
facility: Tosei General Hospital
city: Gifu, Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Himeji, Hyogo
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, Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya
city: Kanagawa, Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Miyagi, Sendai
country: Japan
facility: Tohoku University Hospital
city: Nara, Tenri
country: Japan
facility: Tenri Hospital
city: Osaka, Osaka-sayama
country: Japan
facility: Kindai University Hospital
city: Saitama, Kumagaya
country: Japan
facility: Saitama Cardiovascular and Respiratory Center
city: Sakai, Osaka
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
city: Tochigi, Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima, Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo, Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University
city: Tokyo, Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo, Kiyose
country: Japan
facility: Fukujuji Hospital
city: Tokyo, Minato-ku
country: Japan
facility: Toranomon Hospital
city: Tokyo, Minato-ku
country: Japan
facility: The Jikei University Hospital
city: Tokyo, Ota-ku
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo, Shibuya-ku
country: Japan
facility: JR Tokyo General Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo, Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine
city: Tottori, Yonago
country: Japan
facility: Tottori University Hospital
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital Seoul
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St.Mary's Hospital
city: Mexico DF
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
city: Amsterdam
country: Netherlands
facility: OLVG, locatie Oosterpark
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
city: Lisboa
country: Portugal
facility: CHLC, EPE - Hospital de Santa Marta
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário São João,EPE
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Institute of Pulmonology
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Yedikule Gog. Hst. EAH
city: Izmir
country: Turkey
facility: Ege Universitesi T.F.
city: Izmir
country: Turkey
facility: Dr.Suat Seren EAH
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Westbury On Trym
country: United Kingdom
facility: Southmead Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Crestani B, Huggins JT, Kaye M, Costabel U, Glaspole I, Ogura T, Song JW, Stansen W, Quaresma M, Stowasser S, Kreuter M. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med. 2019 Jan;7(1):60-68. doi: 10.1016/S2213-2600(18)30339-4. Epub 2018 Sep 14.