Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT01170065
Last Updated: 2019-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2010-06-25
2016-09-26
Brief Summary
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The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).
As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BIBF 1120 low qd
Low dose BIBF 1120 once daily
BIBF 1120
Low dose BIBF 1120 once daily
BIBF 1120 low bid
Low dose BIBF 1120 twice daily
BIBF 1120
Low dose BIBF 1120 twice daily
BIBF 1120 medium bid
Intermediate dose BIBF 1120 twice daily
BIBF 1120
Intermediate dose BIBF 1120 twice daily
BIBF 1120 high bid
High dose BIBF 1120 twice daily
BIBF 1120
High dose BIBF 1120 twice daily
Interventions
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BIBF 1120
Intermediate dose BIBF 1120 twice daily
BIBF 1120
High dose BIBF 1120 twice daily
BIBF 1120
Low dose BIBF 1120 twice daily
BIBF 1120
Low dose BIBF 1120 once daily
Eligibility Criteria
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Inclusion Criteria
2. Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
3. Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
Exclusion Criteria
3. Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.
Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
4. Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
5. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
7. Known or suspected active alcohol or drug abuse.
8. Patient not compliant in previous trial, with trial medication or trial visits.
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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INSARES
Mendoza, , Argentina
Respiratory Clinical Trial Pty Ltd.
Glen Osmond, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Royal Perth Hospital-Lung Transplant Unit
Perth, Western Australia, Australia
ULB Hopital Erasme
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
Yvoir - UNIV UCL de Mont-Godinne
Yvoir, , Belgium
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
Sofia, , Bulgaria
QEII Health Sciences Centre (Dalhousie University)
Halifax, Nova Scotia, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Instituto Nacional del Tórax
Santiago, , Chile
Beijing Chao-Yang Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Shanghai Pulmonary Hospital
Shanghai, , China
University Hospital Na Bulovce, Prague
Prague, , Czechia
Masaryk Hospital, Usti nad Labem
Ústí nad Labem, , Czechia
HOP Avicenne
Bobigny, , France
HOP Dijon, Pneumo, Dijon
Dijon, , France
HOP Calmette
Lille, , France
HOP Arnaud de Villeneuve
Montpellier, , France
HOP Pasteur
Nice, , France
HOP Bichat
Paris, , France
Klinik Donaustauf
Donaustauf, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg/Breisgau, , Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Klinikum der Universität München - Campus Großhadern
München, , Germany
University General Hospital of Evros
Alexandroupoli, , Greece
University Hospital of Heraklion, University Pulmonology Cl
Heraklion, , Greece
Csongrad County's Hosp.
Deszk, , Hungary
University of Pecs, 1st internal Med. Dept., Pulmonology
Pécs, , Hungary
Mater Misericordiae University Hospital
Dublin, , Ireland
Ospedale C. G. Mazzoni
Ascoli Piceno, , Italy
Osp. S. Giuseppe Fatebenefratelli
Milan, , Italy
Università di Modena e Reggio Emilia
Modena, , Italy
Università Federico II
Napoli, , Italy
Pol. Universitario Tor Vergata
Roma, , Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, , Italy
Università di Perugia
Terni, , Italy
Ospedale di Cattinara
Trieste, , Italy
Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
Distrito Federal, , Mexico
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, , Netherlands
CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, , Portugal
CHLN, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
Lisbon, , Portugal
Centro Hospitalar São João,EPE
Porto, , Portugal
Central Scientific Research Insitute of Tuberculosis
Moscow, , Russia
Scientific Research Institute of Pulmonology
Saint Petersburg, , Russia
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Dr. Peset
Valencia, , Spain
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
The Medicines Evaluation Unit
Manchester, , United Kingdom
Southmead Hospital
Westbury on Trym, , United Kingdom
Countries
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References
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Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.
Other Identifiers
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2009-013788-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1199.35
Identifier Type: -
Identifier Source: org_study_id
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