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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02788474




Registration number
NCT02788474
Ethics application status
Date submitted
27/05/2016
Date registered
2/06/2016

Titles & IDs
Public title
Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and Limited Forced Vital Capacity Impairment
Scientific title
A 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.
Secondary ID [1] 0 0
2015-003148-38
Secondary ID [2] 0 0
1199.227
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic 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
Placebo comparator: placebo -

Experimental: nintedanib -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.
Timepoint [1] 0 0
baseline and 12 weeks
Secondary outcome [1] 0 0
Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12
Timepoint [2] 0 0
baseline and 12 weeks
Secondary outcome [3] 0 0
The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12
Timepoint [3] 0 0
baseline and 12 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

* Written informed consent consistent with International Conference on Harmonisation Good Clinical Practice and local laws, signed prior to participation in the trial including any study related procedures being performed;
* Male or female patients aged >=40 years at Visit 1;
* A clinical diagnosis of Idiopathic pulmonary fibrosis (IPF) within the last 3 years from visit 0, based upon the American Thoracic Society/ European Respiratory Society /Japanese Respiratory Society/ Latin American Thoracic Association 2011 guideline;
* Chest high resolution computed tomography (HRCT) scan performed within 18 months of Visit 0;
* Combination of HRCT pattern, and surgical lung biopsy pattern (the latter if available) as assessed by central review are consistent with the diagnosis of Idiopathic pulmonary fibrosis;
* Forced vital capacity (FVC) >=80% of predicted normal at Visit 1.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Alanine transaminase, Aspartate aminotransferase > 1.5 fold upper limit of normal (ULN) at Visit 1;
* Total bilirubin > 1.5 fold ULN at Visit 1;
* Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment);
* Relevant airways obstruction, i.e. pre-bronchodilator Forced expiratory volume in 1 second / Forced vital capacity < 0.70;
* History of myocardial infarction within 6 months of visit 1 or unstable angina within 1 month of Visit 1;
* Bleeding Risk:

* Known genetic predisposition to bleeding;
* Patients who require fibrinolysis, full-dose therapeutic anticoagulation or high dose antiplatelet therapy;
* History of haemorrhagic central nervous system (CNS) event within 12 months prior to Visit 1;
* History of haemoptysis or haematuria, active gastro-intestinal bleeding or ulcers and/or major injury or surgery within 3 months prior to Visit 1;
* International normalised ratio (INR) > 2 at Visit 1;
* Prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of ULN at Visit 1;
* Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery;
* History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1;
* Creatinine clearance < 30 mL/min calculated by Cockcroft-Gault formula at Visit 1;
* Treatment with nintedanib, pirfenidone, azathioprine, cyclophosphamide, cyclosporine, any other investigational drug, n-acetylcysteine, prednisone/prednisolone >15 mg daily or >30 mg every 2 days OR use of other systemic corticosteroids as well as any investigational drugs within 4 weeks of Visit 2;
* Known hypersensitivity to nintedanib, peanut, soya or to any other components of the study medication;
* Prior discontinuation of nintedanib treatment due to intolerability/ adverse events considered drug related;
* A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial;
* Alcohol or drug abuse which in the opinion of the treating physician would interfere with the treatment and would affect patient's ability to participate in this trial;
* Patients not able to understand and follow any study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help;
* Women who are pregnant, nursing, who plan to become pregnant while in the trial or female patients with positive pregnancy (ß-HCG) test at Visit 1 and/or Visit 2;
* Women of childbearing potential4 not willing or able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly.
* Patients with acute IPF exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period;
* Patients who are or have been participating in another trial with investigational drug/s within one month prior to Visit 1 and patients who have previously been enrolled in this trial;
* Further exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
9/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/06/2018
Sample size
Target
Accrual to date
Final
347
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown, Sydney
Recruitment hospital [2] 0 0
Concord General Repatriation Hospital -Ambulatory Care Unit - Concord
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown, Sydney
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Edegem
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Liège
Country [12] 0 0
Belgium
State/province [12] 0 0
Yvoir
Country [13] 0 0
Czechia
State/province [13] 0 0
Olomouc
Country [14] 0 0
Czechia
State/province [14] 0 0
Plzen
Country [15] 0 0
Czechia
State/province [15] 0 0
Praha 4
Country [16] 0 0
Czechia
State/province [16] 0 0
Praha
Country [17] 0 0
Czechia
State/province [17] 0 0
Usti nad Labem
Country [18] 0 0
Finland
State/province [18] 0 0
Helsinki
Country [19] 0 0
Finland
State/province [19] 0 0
Kuopio
Country [20] 0 0
Finland
State/province [20] 0 0
Oulu
Country [21] 0 0
Finland
State/province [21] 0 0
Tampere
Country [22] 0 0
Finland
State/province [22] 0 0
Turku
Country [23] 0 0
France
State/province [23] 0 0
Brest
Country [24] 0 0
France
State/province [24] 0 0
Bron
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Reims Cedex
Country [27] 0 0
France
State/province [27] 0 0
Rennes
Country [28] 0 0
France
State/province [28] 0 0
Strasbourg
Country [29] 0 0
France
State/province [29] 0 0
Tours
Country [30] 0 0
Germany
State/province [30] 0 0
Bamberg
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Gießen
Country [33] 0 0
Germany
State/province [33] 0 0
Greifswald
Country [34] 0 0
Germany
State/province [34] 0 0
Grosshansdorf
Country [35] 0 0
Germany
State/province [35] 0 0
Hannover
Country [36] 0 0
Germany
State/province [36] 0 0
Heidelberg
Country [37] 0 0
Germany
State/province [37] 0 0
Immenhausen
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Germany
State/province [39] 0 0
Münster
Country [40] 0 0
Hungary
State/province [40] 0 0
Budapest
Country [41] 0 0
Hungary
State/province [41] 0 0
Deszk
Country [42] 0 0
Hungary
State/province [42] 0 0
Farkasgyepu
Country [43] 0 0
Hungary
State/province [43] 0 0
Miskolc
Country [44] 0 0
Japan
State/province [44] 0 0
Aichi, Seto
Country [45] 0 0
Japan
State/province [45] 0 0
Fukuoka, Kurume
Country [46] 0 0
Japan
State/province [46] 0 0
Ibaraki, Naka-gun
Country [47] 0 0
Japan
State/province [47] 0 0
Kanagawa, Yokohama
Country [48] 0 0
Japan
State/province [48] 0 0
Osaka, Osakasayama
Country [49] 0 0
Japan
State/province [49] 0 0
Osaka, Sakai
Country [50] 0 0
Japan
State/province [50] 0 0
Tokushima, Tokushima
Country [51] 0 0
Japan
State/province [51] 0 0
Tokyo, Bunkyo-ku
Country [52] 0 0
Japan
State/province [52] 0 0
Tokyo, Ota-ku
Country [53] 0 0
Japan
State/province [53] 0 0
Tokyo, Shinjuku-ku
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seongnam
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seoul
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Katowice
Country [58] 0 0
Poland
State/province [58] 0 0
Krakow
Country [59] 0 0
Poland
State/province [59] 0 0
Lodz
Country [60] 0 0
Poland
State/province [60] 0 0
Torun
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Galdakao
Country [63] 0 0
Spain
State/province [63] 0 0
L'Hospitalet Llobregat (bcn)
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Majadahonda (Madrid)
Country [66] 0 0
Spain
State/province [66] 0 0
Pozuelo de Alarcón
Country [67] 0 0
Spain
State/province [67] 0 0
Sabadell
Country [68] 0 0
Spain
State/province [68] 0 0
Sevilla
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Bristol
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Cambridge
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Exeter
Country [73] 0 0
United Kingdom
State/province [73] 0 0
London
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Manchester
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Oxford

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02788474