Clinical trial NCT01170065: Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 198
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

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.


Eligibility criteria: Inclusion criteria:

1. Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
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:

1. Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
2. Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
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.

Primary outcomes:
measure: Annual Rate of Decline in Forced Vital Capacity (FVC)
timeFrame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcomes:
measure: Overall Survival
timeFrame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
measure: Progression-Free Survival
timeFrame: From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
measure: Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
timeFrame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
measure: Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
timeFrame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
measure: Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
timeFrame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
measure: Time to First Acute IPF Exacerbation
timeFrame: From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
measure: Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs
timeFrame: From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: INSARES
city: Glen Osmond
country: Australia
facility: Respiratory Clinical Trial Pty Ltd.
state: South Australia
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Perth
country: Australia
facility: Royal Perth Hospital-Lung Transplant Unit
state: Western Australia
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: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericordia de Porto Alegre
city: Sofia
country: Bulgaria
facility: Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic
city: Halifax
country: Canada
facility: QEII Health Sciences Centre (Dalhousie University)
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Santiago
country: Chile
facility: Instituto Nacional del Tórax
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Shanghai Pulmonary 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: Bobigny
country: France
facility: HOP Avicenne
city: DIJON Cedex
country: France
facility: HOP Dijon, Pneumo, Dijon
city: Lille Cedex
country: France
facility: HOP Calmette
city: Lille
country: France
facility: HOP Calmette
city: Montpellier
country: France
facility: HOP Arnaud de Villeneuve
city: Nice Cedex 1
country: France
facility: HOP Pasteur
city: Paris Cedex 18
country: France
facility: HOP Bichat
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: Großhansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: München
country: Germany
facility: Klinikum der Universität München - Campus Großhadern
city: Alexandroupolis
country: Greece
facility: University General Hospital of Evros
city: Heraklion
country: Greece
facility: University Hospital of Heraklion, University Pulmonology Cl
city: Deszk
country: Hungary
facility: Csongrad County's Hosp.
city: Pecs
country: Hungary
facility: University of Pecs, 1st internal Med. Dept., Pulmonology
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Ascoli Piceno
country: Italy
facility: Ospedale C. G. Mazzoni
city: Milano
country: Italy
facility: Osp. S. Giuseppe Fatebenefratelli
city: Modena
country: Italy
facility: Università di Modena e Reggio Emilia
city: Napoli
country: Italy
facility: Università Federico II
city: Roma
country: Italy
facility: Pol. Universitario Tor Vergata
city: Siena
country: Italy
facility: A.O.U. Senese Policlinico Santa Maria alle Scotte
city: Terni
country: Italy
facility: Università di Perugia
city: Trieste
country: Italy
facility: Ospedale di Cattinara
city: Distrito Federal
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas
city: Nieuwegein
country: Netherlands
facility: St. Antonius ziekenhuis, locatie Nieuwegein
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
city: Lisboa
country: Portugal
facility: CHLN, EPE - Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente
city: Porto
country: Portugal
facility: Centro Hospitalar São João,EPE
city: Moscow
country: Russian Federation
facility: Central Scientific Research Insitute of Tuberculosis
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Institute of Pulmonology
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Valencia
country: Spain
facility: Hospital Dr. Peset
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Manchester
country: United Kingdom
facility: The Medicines Evaluation Unit
city: Westbury On Trym
country: United Kingdom
facility: Southmead Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.