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

NCT01619085 | Completed Phase 3 Results

• 2 other identifiers: 1199.332011-002766-21
• Study Type: interventional
• Target: 752
• Locations: 24 countries
• Sites: 173

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

All subjects

EXPERIMENTAL

patient to receive a capsule containing Nintedanib twice a day

Drug: Nintedanib

Interventions

Nintedanib DRUG

Nintedanib twice a day

Also known as: BIBF 1120

All subjects

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
• Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

You may not qualify if:

• 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)
• Bilirubin \> 1.5 fold ULN
• Bleeding risk
• Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
• New major thrombo-embolic events developed after completion of the parent trial.
• Time period \> 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
• 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.
• 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.
• Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (173)

Jasper Summit Research, LLC

Jasper, Alabama, 35501, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

University of California

Los Angeles, California, 90095-1690, United States

Location

University of California

San Francisco, California, 94143, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of California

Torrance, California, 90505, United States

Location

Western Connecticut Medical Group

Danbury, Connecticut, 06810, United States

Location

Pulmonary Assoc of Stamford

Stamford, Connecticut, 06902, United States

Location

Cleveland Clinic

Weston, Florida, 33331, United States

Location

Georgia Clinical Research

Austell, Georgia, 30106, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Via Christi Clinic, PA

Wichita, Kansas, 67208, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Minnesota Lung Center

Minneapolis, Minnesota, 55407, United States

Location

The Lung Research Center, LLC

Chesterfield, Missouri, 63017, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Pulmonary and Critical Care Associates

Albany, New York, 12205, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0565, United States

Location

ID Clinical Research, LTD

Toledo, Ohio, 43608, United States

Location

The Oregon Clinic

Portland, Oregon, 97220, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-5735, United States

Location

FDC Seifer PLC Pulmonary

Shelbyville, Tennessee, 37160, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235-8550, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Metroplex Pul and Sleep Ctr

McKinney, Texas, 75069-1769, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Lynchburg Pulmonary Associates

Lynchburg, Virginia, 24501, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Repatriation General Hospital

Concord, New South Wales, 2137, Australia

Location

Frankston Hospital

Frankston, Victoria, 3199, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3000, Australia

Location

ULB Hopital Erasme

Brussels, 1070, Belgium

Location

Brussels - UNIV UZ Brussel

Brussels, 1090, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Yvoir - UNIV UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Instituto Nacional del Tórax

Santiago, 7500000, Chile

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Friendship Hospital

Beijing, 100050, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Xiangya Hospital, Central South University

Changsha, 410008, China

Location

West China Hospital

Chengdu, 610042, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, 330006, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

General Hospital of Shenyang Military Region

Shenyang, 110015, China

Location

Xijing Hospital

Xi'an, 710032, China

Location

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

Location

Thomayer Hospital

Prague, 140 59, Czechia

Location

University Hospital Na Bulovce, Prague

Prague, 180 81, Czechia

Location

Masaryk Hospital, Usti nad Labem

Ústí nad Labem, 401 13, Czechia

Location

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, 00029, Finland

Location

Mehiläinen Kielotie, Vantaa

Vantaa, 01300, Finland

Location

HOP Avicenne

Bobigny, 93009, France

Location

HOP Bocage

Dijon, 21079, France

Location

HOP Calmette

Lille, 59037, France

Location

HOP Louis Pradel

Lyon, 69677, France

Location

HOP Nord

Marseille, 13015, France

Location

HOP Arnaud de Villeneuve

Montpellier, 34295, France

Location

HOP Pasteur

Nice, 06002, France

Location

HOP Européen G. Pompidou

Paris, 75015, France

Location

HOP Bichat

Paris, 75877, France

Location

HOP Tenon

Paris, 75970, France

Location

HOP Maison Blanche

Reims, 51092, France

Location

HOP Pontchaillou

Rennes, 35033, France

Location

HOP Larrey

Toulouse, 31059, France

Location

CIMS Studienzentrum Bamberg GmbH

Bamberg, 96049, Germany

Location

Helios Klinikum Emil von Behring

Berlin, 14165, Germany

Location

Evangelische Lungenklinik Berlin

Buch, 13125, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Coswig, 01640, Germany

Location

Klinik Donaustauf

Donaustauf, 93093, Germany

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45239, Germany

Location

Universitätsklinikum Freiburg

Freiburg/Breisgau, 79106, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35392, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

Großhansdorf, 22927, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Klinikum der Universität München - Campus Großhadern

München, 81377, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Athens Hospital of Chest Diseases "Sotiria"

Athens, 11527, Greece

Location

University Hospital of Heraklion, University Pulmonology Cl

Heraklion, 71100, Greece

Location

General University Hospital of Larissa

Larissa, 41110, Greece

Location

Mehta Hospital & Cardiopulmonary Care Centre

Ahmedabad, 380054, India

Location

Chest & Maternity Center

Bangalore, 560010, India

Location

Asthma Bhawan

Jaipur, 302023, India

Location

National Allergy Asthma Bronchitis Institute, Kolkata

Kolkata, 700017, India

Location

P.D. Hinduja National Hospital

Mumbai, 400016, India

Location

Jahingir Clinical Development Centre

Pune, 411001, India

Location

Mater Misericordiae University Hospital

Dublin, 7, Ireland

Location

Rabin Medical Center Beilinson

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Osp. Clin. SS. Anunziata

Chieti Scalo, 56100, Italy

Location

Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

Forlì, 47100, Italy

Location

Osp. S. Giuseppe Fatebenefratelli

Milan, 20123, Italy

Location

Università di Modena e Reggio Emilia

Modena, 41100, Italy

Location

A.O. San Gerardo di Monza

Monza, 20052, Italy

Location

Università Federico II

Napoli, 80131, Italy

Location

Università degli Studi Padova

Padua, 35128, Italy

Location

Ospedale di Cisanello

Pisa, 56100, Italy

Location

Ospedale di Cisanello

Pisa, 56124, Italy

Location

Pol. Universitario Tor Vergata

Roma, 00133, Italy

Location

A.O.U. Senese Policlinico Santa Maria alle Scotte

Siena, 53100, Italy

Location

Nagoya University Hospital

Aichi, Nagoya, 466-8560, Japan

Location

Tosei General Hospital

Aichi, Seto, 489-8642, Japan

Location

Ogaki Municipal Hospital

Gifu, Ogaki, 503-0864, Japan

Location

National Hospital Organization Himeji Medical Center

Himeji, Hyogo, 670-8520, Japan

Location

Kobe City Medical Center General Hospital

Hyogo, Kobe, 650-0047, Japan

Location

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, 319-1113, Japan

Location

Toranomon Hospital Kajigaya

Kanagawa, Kawasaki, 213-0015, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051, Japan

Location

Tohoku University Hospital

Miyagi, Sendai, 980-8574, Japan

Location

Tenri Hospital

Nara, Tenri, 632-8552, Japan

Location

Kindai University Hospital

Osaka, Osaka-sayama, 589-8511, Japan

Location

Saitama Cardiovascular and Respiratory Center

Saitama, Kumagaya, 360-0105, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai, Osaka, 591-8555, Japan

Location

Jichi Medical University Hospital

Tochigi, Shimotsuke, 329-0498, Japan

Location

Tokushima University Hospital

Tokushima, Tokushima, 770-0042, Japan

Location

Tokyo Medical and Dental University

Tokyo, Bunkyo-ku, 113-8519, Japan

Location

Nippon Medical School Hospital

Tokyo, Bunkyo-ku, 113-8603, Japan

Location

Fukujuji Hospital

Tokyo, Kiyose, 204-0022, Japan

Location

Toranomon Hospital

Tokyo, Minato-ku, 105-0001, Japan

Location

The Jikei University Hospital

Tokyo, Minato-ku, 105-0003, Japan

Location

Toho University Omori Medical Center

Tokyo, Ota-ku, 143-0015, Japan

Location

JR Tokyo General Hospital

Tokyo, Shibuya-ku, 151-0053, Japan

Location

Tokyo Medical University Hospital

Tokyo, Shinjuku-ku, 160-0023, Japan

Location

Center Hospital of the National Center for Global Health and Medicine

Tokyo, Shinjuku-ku, 162-8555, Japan

Location

Tottori University Hospital

Tottori, Yonago, 683-0826, Japan

Location

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

Mexico City, 14080, Mexico

Location

OLVG, locatie Oosterpark

Amsterdam, 1091 AC, Netherlands

Location

St. Antonius ziekenhuis, locatie Nieuwegein

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

Coimbra, 3041-801, Portugal

Location

CHLC, EPE - Hospital de Santa Marta

Lisbon, 1196-024, Portugal

Location

Centro Hospitalar Lisboa Norte Hospital Pulido Valente

Lisbon, 1750-001 L, Portugal

Location

Centro Hospitalar Universitário São João,EPE

Porto, 4202-451, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, 4434-502, Portugal

Location

Scientific Research Institute of Pulmonology

Saint Petersburg, 197022, Russia

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, 420-767, South Korea

Location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Soonchunhyang University Hospital Seoul

Seoul, 140-743, South Korea

Location

The Catholic University of Korea, Yeouido St.Mary's Hospital

Seoul, 150-713, South Korea

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Nuestra Señora de Valme

Seville, 41014, Spain

Location

Ankara Universitesi Tip Fakultesi

Ankara, 06100, Turkey (Türkiye)

Location

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Yedikule Gog. Hst. EAH

Istanbul, 34760, Turkey (Türkiye)

Location

Ege Universitesi T.F.

Izmir, 35100, Turkey (Türkiye)

Location

Dr.Suat Seren EAH

Izmir, 35120, Turkey (Türkiye)

Location

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Birmingham Heartlands Hospital

Birmingham, B9 5SS, United Kingdom

Location

St James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Southmead Hospital

Westbury on Trym, BS10 5NB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30224318 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 14, 2012
• Study Start: June 6, 2012
• Primary Completion: July 5, 2017
• Study Completion: February 1, 2021
• Last Updated: March 25, 2022
• Results First Posted: July 26, 2018

Record last verified: 2022-02

Locations

CL (1); KR (6); AU (4); TU (5); IL (2); JP (25); CA (2); RU (1); CN (11); US (37); FI (2); FR (13); IN (6); ME (1); ES (4); BE (4); IE (1); GB (8); DE (15); NL (3); GR (3); CZ (3); PT (5); IT (11)