A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis

January 24, 2024 updated by: Boehringer Ingelheim

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426BOR
        • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
      • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
        • APRILLUS-Asistencia e Investigacion
      • Florida, Argentina, B1602DQD
        • CEMER-Centro Medico De Enfermedades Respiratorias
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital Melbourne
  • Austria
      • Innsbruck, Austria, A-6020
        • Medical University of Innsbruck
  • Belgium
      • Gent, Belgium, 9000
        • UNIV UZ Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liege
  • Brazil
      • Curitiba, Brazil, 80440-080
        • Edumed - Educacao e Saude SA
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • HSCM
  • Chile
      • Concepción, Chile, 4070038
        • Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"
      • Talca, Chile, 3465586
        • Centro de Investigación del Maule
  • China
      • Beijing, China, 100032
        • Peking Union Medical College Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Chengdu, China, 610041
        • West China Hospital
      • Hefei, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Shanghai, China, 200040
        • Huashan Hospital, Fudan University
      • Shenyang, China, 110001
        • The First Hospital of China Medical University
  • Czechia
      • Prague, Czechia, 12850
        • Institute of Rheumathology Prague
  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital
      • Odense, Denmark, 5000 C
        • Odense University Hospital
  • Finland
      • Helsinki, Finland, 00290
        • HYKS Keuhkosairauksien tutkimusyksikkö
      • Turku, Finland, 20521
        • TYKS
  • France
      • Bobigny, France, 93009
        • HOP Avicenne
      • Bron, France, 69677
        • HOP Louis Pradel
      • Lille, France, 59037
        • Hop Claude Huriez
      • Lille, France, 59037
        • CHRU LILLE
      • Montpellier, France, 34295
        • HOP Arnaud de Villeneuve
      • Nantes, France, 44093
        • HOP Hôtel-Dieu
      • Nice, France, 06001
        • HOP Pasteur
      • Paris, France, 75877
        • HOP Bichat
      • Rennes, France, 35033
        • HOP Pontchaillou
      • Rouen, France, 76000
        • HOP Charles Nicolle
      • Toulouse, France, 31059
        • HOP Larrey
      • Tours, France, 37044
        • HOP Bretonneau
  • Germany
      • Donaustauf, Germany, 93093
        • Klinik Donaustauf
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Greifswald, Germany, 17475
        • Universitätsmedizin Greifswald
      • Hamburg, Germany, 22763
        • Asklepios Klinik Altona
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
      • Münster, Germany, 48149
        • Universitätsklinikum Münster
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens "Laiko"
  • India
      • Bangalore, India, 560054
        • Ramaiah Medical College and Hospitals
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical Education and Research
      • Delhi, India, 110060
        • Sir Gangaram Hospital
      • Hyderabad, India, 500082
        • Nizam's Institute of Medical Sciences
      • Hyderabad, India, 500034
        • Care hospital
      • Jaipur, India, 302039
        • Asthma Bhawan
      • Nagpur, India, 440012
        • Getwell Hospital & Research Institute
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Pune, India, 411001
        • B.J. Medical College and Sasoon General Hospital
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Haifa, Israel, 31048
        • Bnei Zion Medical Center, Haifa
      • Petah Tiqwa, Israel, 49100
        • Rabin Medical Center Beilinson
      • Tel Aviv, Israel, 64239
        • Sourasky Medical Center
  • Italy
      • Genova, Italy, 16132
        • Università degli Studi di Genova
      • Monza, Italy, 20900
        • A.O. San Gerardo di Monza
      • Napoli, Italy, 80138
        • A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli
      • Padova, Italy, 35128
        • Università degli Studi Padova
      • Roma, Italy, 00161
        • Azienda Universitaria-Universita' La Sapienza
  • Japan
      • Aichi, Seto, Japan, 489-8642
        • Tosei General Hospital
      • Fukuoka, Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Hokkaido, Sapporo, Japan, 060-8543
        • Sapporo Medical University Hospital
      • Hyogo, Himeji, Japan, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Kanagawa, Kawasaki, Japan, 216-8511
        • St. Marianna University Hospital
      • Kanagawa, Sagamihara, Japan, 252-0375
        • Kitasato University Hospital
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Osaka, Osakasayama, Japan, 589-8511
        • Kindai University Hospital
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
      • Osaka, Takatsuki, Japan, 569-8686
        • Osaka Medical College Hospital
      • Saitama, Iruma-gun, Japan, 350-0495
        • Saitama Medical University Hospital
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Hamamatsu University Hospital
      • Tokushima, Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Tokyo, Bunkyo-Ku, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Bunkyo-Ku, Japan, 113-8603
        • Nippon Medical School Hospital
      • Tokyo, Ota-ku, Japan, 143-8541
        • Toho University Omori Medical Center
      • Tokyo, Shinjyuku-ku, Japan, 162-0054
        • Institute of Rheumatology Tokyo Women's Medical University
  • Malaysia
      • Georgetown Pulau Pinang, Malaysia, 10990
        • Hospital Pulau Pinang
      • Kuala Lumpur, Malaysia, 59100
        • University of Malaya Medical Centre
  • Mexico
      • Ciudad de México, Mexico, 14080
        • Instituto Nacional de Enfermedades Respiratorias Ismael Cosió Villegas
  • Netherlands
      • Amsterdam, Netherlands, 1081HV
        • Amsterdam UMC Locatie VUMC
      • Leiden, Netherlands, 2333 ZA
        • Leids Universitair Medisch Centrum (LUMC)
      • Nijmegen, Netherlands, 6525 GA
        • Radboud Universitair Medisch Centrum
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum
  • Norway
      • Oslo, Norway, N-0372
        • Oslo Universitetssykehus HF, Rikshospitalet
      • Tromsø, Norway, N-9038
        • Universitetssykehuset Nord-Norge, Tromsø
  • Poland
      • Bydgoszcz, Poland, 85168
        • Dr.Biziel UnivHosp#2,Rheumat&Connec.Tissue Disease,Bydgoszcz
      • Krakow, Poland, 30033
        • Specialist Allergy-Internist Center ALL-MED
      • Rzeszow, Poland, 35205
        • EMED, Center of Medical Services,Private Prac,Rzeszow
      • Wroclaw, Poland, 50-368
        • Indep.Pblic Clin.Hosp#1,Dermatol,Venereol&Allerg.dep,Wroclaw
  • Portugal
      • Almada, Portugal, 2801-951
        • Hospital Garcia de Orta, EPE
      • Amadora, Portugal, 2720-276
        • Hospital Fernando Fonseca, EPE
      • Coimbra, Portugal, 3000-075
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
      • Ponte de Lima, Portugal, 4990-041
        • ULSAM, EPE - Hospital Conde de Bertiandos
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitário São João,EPE
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain, 08026
        • Hospital Santa Creu i Sant Pau
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Valencia, Spain, 46026
        • Hospital Politècnic La Fe
      • Valencia, Spain, 46017
        • Hospital Dr. Peset
      • Vigo, Spain, 36312
        • Hospital Álvaro Cunqueiro
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Clinical Rheumatology Research Center Sahlgrenska
  • Switzerland
      • Zürich, Switzerland, 8091
        • University Hospital Zurich
  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi hospital
      • Muang, Thailand, 40002
        • Srinagarind Hospital
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • University of California Los Angeles
      • Sacramento, California, United States, 95817
        • University of California Davis
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida College of Medicine
      • Miami, Florida, United States, 33125
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital and Clinic
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic, Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
      • New York, New York, United States, 10032
        • Columbia University Medical Center-New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Toledo, Ohio, United States, 43614
        • University of Toledo
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Health Sciences Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Nintedanib
Administered twice daily
Other Names:
  • OVEF

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Any Adverse Event (AE) Over the Course of the Trial
Time Frame: First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.
Number of patients with any adverse event (AE) over the course of the trial.
First trial medication intake up to last trial drug intake, plus 7 days residual effect period, up to approximate 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1199-0225
  • 2016-003403-66 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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'.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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