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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01170065




Registration number
NCT01170065
Ethics application status
Date submitted
6/07/2010
Date registered
27/07/2010
Date last updated
6/06/2019

Titles & IDs
Public title
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
Scientific 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
Secondary ID [1] 0 0
2009-013788-21
Secondary ID [2] 0 0
1199.35
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIBF 1120
Treatment: Drugs - BIBF 1120
Treatment: Drugs - BIBF 1120
Treatment: Drugs - BIBF 1120

Experimental: BIBF 1120 low qd - Low dose BIBF 1120 once daily

Experimental: BIBF 1120 low bid - Low dose BIBF 1120 twice daily

Experimental: BIBF 1120 medium bid - Intermediate dose BIBF 1120 twice daily

Experimental: BIBF 1120 high bid - High dose BIBF 1120 twice daily


Treatment: Drugs: BIBF 1120
Intermediate dose BIBF 1120 twice daily

Treatment: Drugs: BIBF 1120
High dose BIBF 1120 twice daily

Treatment: Drugs: BIBF 1120
Low dose BIBF 1120 twice daily

Treatment: Drugs: BIBF 1120
Low dose BIBF 1120 once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Rate of Decline in Forced Vital Capacity (FVC)
Timepoint [1] 0 0
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcome [2] 0 0
Progression-Free Survival
Timepoint [2] 0 0
From first trial drug intake in 1199.35 to disease progression; up to 61.8 months
Secondary outcome [3] 0 0
Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease
Timepoint [3] 0 0
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcome [4] 0 0
Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation
Timepoint [4] 0 0
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcome [5] 0 0
Incidence of Patients With at Least One Acute IPF Exacerbation Over Time
Timepoint [5] 0 0
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcome [6] 0 0
Time to First Acute IPF Exacerbation
Timepoint [6] 0 0
From first drug administration in 1199.35 until database lock 15Oct2015, up to 61.8 Months
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
From the first nintedanib intake in trial 1199.35 to the last nintedanib intake + 28 days; up to 61.8 months + 28 days

Eligibility
Key inclusion 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)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/09/2016
Sample size
Target
Accrual to date
Final
198
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Respiratory Clinical Trial Pty Ltd. - Glen Osmond
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 0 0
Royal Perth Hospital-Lung Transplant Unit - Perth
Recruitment postcode(s) [1] 0 0
5064 - Glen Osmond
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Mendoza
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Yvoir
Country [5] 0 0
Brazil
State/province [5] 0 0
Porto Alegre
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Canada
State/province [7] 0 0
Nova Scotia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Chile
State/province [9] 0 0
Santiago
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Nanjing
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
Czechia
State/province [13] 0 0
Prague 8
Country [14] 0 0
Czechia
State/province [14] 0 0
Usti nad Labem
Country [15] 0 0
France
State/province [15] 0 0
Bobigny
Country [16] 0 0
France
State/province [16] 0 0
DIJON Cedex
Country [17] 0 0
France
State/province [17] 0 0
Lille Cedex
Country [18] 0 0
France
State/province [18] 0 0
Lille
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Nice Cedex 1
Country [21] 0 0
France
State/province [21] 0 0
Paris Cedex 18
Country [22] 0 0
Germany
State/province [22] 0 0
Donaustauf
Country [23] 0 0
Germany
State/province [23] 0 0
Essen
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg/Breisgau
Country [25] 0 0
Germany
State/province [25] 0 0
Großhansdorf
Country [26] 0 0
Germany
State/province [26] 0 0
Mainz
Country [27] 0 0
Germany
State/province [27] 0 0
München
Country [28] 0 0
Greece
State/province [28] 0 0
Alexandroupolis
Country [29] 0 0
Greece
State/province [29] 0 0
Heraklion
Country [30] 0 0
Hungary
State/province [30] 0 0
Deszk
Country [31] 0 0
Hungary
State/province [31] 0 0
Pecs
Country [32] 0 0
Ireland
State/province [32] 0 0
Dublin
Country [33] 0 0
Italy
State/province [33] 0 0
Ascoli Piceno
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Modena
Country [36] 0 0
Italy
State/province [36] 0 0
Napoli
Country [37] 0 0
Italy
State/province [37] 0 0
Roma
Country [38] 0 0
Italy
State/province [38] 0 0
Siena
Country [39] 0 0
Italy
State/province [39] 0 0
Terni
Country [40] 0 0
Italy
State/province [40] 0 0
Trieste
Country [41] 0 0
Mexico
State/province [41] 0 0
Distrito Federal
Country [42] 0 0
Netherlands
State/province [42] 0 0
Nieuwegein
Country [43] 0 0
Portugal
State/province [43] 0 0
Coimbra
Country [44] 0 0
Portugal
State/province [44] 0 0
Lisboa
Country [45] 0 0
Portugal
State/province [45] 0 0
Porto
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Moscow
Country [47] 0 0
Russian Federation
State/province [47] 0 0
St. Petersburg
Country [48] 0 0
Spain
State/province [48] 0 0
Barcelona
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Birmingham
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Westbury On Trym

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01170065
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01170065