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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03313180




Registration number
NCT03313180
Ethics application status
Date submitted
13/10/2017
Date registered
18/10/2017

Titles & IDs
Public title
A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis
Scientific title
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
Secondary ID [1] 0 0
2016-003403-66
Secondary ID [2] 0 0
1199-0225
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Diseases, Interstitial 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Nintedanib

Experimental: Nintedanib - Patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) who took part in the parent trials 1199.214 (Nintedanib or Placebo) or 1199-0340 (Nintedanib). Patients continued in this trial and received Nintedanib 150 mg (milligram) twice daily (bid) unless they had reduced their dose to 100 mg bid trial medication (Nintedanib or Placebo) in the parent trial.

Patients receiving 100 mg bid trial medication at the end of the parent trial could receive either Nintedanib 100 mg bid or 150 mg bid at the discretion of the investigator.


Treatment: Drugs: Nintedanib
Administered twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Patients With Any Adverse Event (AE) Over the Course of the Trial
Timepoint [1] 0 0
First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.

Eligibility
Key inclusion criteria
* Patients who completed the parent trial 1199.214/1199-0340 per protocol and did not permanently discontinue study treatment
* Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Women of childbearing potential must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to nintedanib treatment initiation, during the trial and for 3 months after last intake of nintedanib.
* Further inclusion criteria apply
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
* Bilirubin > 2 x ULN
* Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.
* Clinically relevant anaemia at investigators discretion.
* Bleeding risk, any of the following

* Known genetic predisposition to bleeding according to the judgement of the investigator
* Patients who require

* Fibrinolysis, full-dose therapeutic anticoagulation
* High dose antiplatelet therapy.
* Hemorrhagic central nervous system (CNS) event after completion of the parent trial 1199.214/1199-0340
* Any of the following after last treatment of 1199.214/1199-0340:

* Haemoptysis or haematuria
* Active gastro-intestinal bleeding or Gastrointestinal (GI) - ulcers
* Gastric antral vascular ectasia (GAVE)
* Major injury or surgery
* Coagulation parameters: International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN at Visit 1.
* New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340:

* Stroke;
* Deep vein thrombosis;
* Pulmonary embolism;
* Myocardial infarction.
* Major surgery performed within the next 3 months
* Time period > 12 weeks between last drug intake in 1199.214 or > 1 week between last nintedanib intake in trial 1199-0340 and Visit 2 of this trial
* Usage of any investigational drug after completion of 1199.214/1199-0340 or planned usage of an investigational drug during the course of this trial.
* A disease or condition which may put the patient at risk because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the patient's ability to participate in this trial
* Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable trial subject or unlikely to complete the trial
* Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
* Women who are pregnant, nursing, or who plan to become pregnant while in the trial
* Previous enrolment in this trial
* Further exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 3
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
27/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/01/2023
Sample size
Target
Accrual to date
Final
444
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Iowa
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Kansas
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Louisiana
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Massachusetts
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Missouri
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North Carolina
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma Buenos Aires
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Florida
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Austria
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Innsbruck
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Belgium
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Gent
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Leuven
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Belgium
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Liège
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Brazil
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Canada
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Chile
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Concepción
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Dresden
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Germany
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Erlangen
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Germany
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Greifswald
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Kiel
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Münster
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Tübingen
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Greece
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India
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Delhi
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Jaipur
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India
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Nagpur
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Pune
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Petah Tiqwa
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Tel Aviv
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Italy
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Genova
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Italy
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Monza
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Napoli
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Italy
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Padova
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Roma
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Japan
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Aichi, Seto
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Fukuoka, Kurume
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Hokkaido, Sapporo
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Hyogo, Himeji
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Kanagawa, Sagamihara
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Nagasaki, Nagasaki
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Osaka, Osakasayama
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Osaka, Takatsuki
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Saitama, Iruma-gun
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Shizuoka, Hamamatsu
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Tokushima, Tokushima
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Tokyo, Bunkyo-Ku
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Tokyo, Ota-ku
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Tokyo, Shinjyuku-ku
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Malaysia
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Georgetown Pulau Pinang
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Leiden
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Rotterdam
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Norway
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Oslo
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Norway
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Tromsø
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Poland
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Bydgoszcz
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Krakow
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Rzeszow
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Poland
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Wroclaw
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Portugal
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Almada
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Portugal
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Amadora
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Coimbra
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Portugal
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Ponte de Lima
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Vigo
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Sweden
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Gothenburg
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Switzerland
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Zürich
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Thailand
State/province [129] 0 0
Bangkok
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Thailand
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Muang
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Thailand
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Songkhla
Country [132] 0 0
United Kingdom
State/province [132] 0 0
London
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United Kingdom
State/province [133] 0 0
Salford

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
Address 0 0
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?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this 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".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to 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.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
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 both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing 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/NCT03313180