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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03313180
Recruitment Status : Active, not recruiting
First Posted : October 18, 2017
Last Update Posted : July 27, 2021
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lung Diseases, Interstitial Drug: Nintedanib Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 444 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
Actual Study Start Date : November 27, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: All patients Drug: Nintedanib
Administered twice daily
Other Name: OVEF

Primary Outcome Measures :
  1. Incidence of overall adverse events over the course of this extension trial [ Time Frame: Up to 34 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03313180

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Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT03313180    
Other Study ID Numbers: 1199-0225
2016-003403-66 ( EudraCT Number )
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link 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 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
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'.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action