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

Completed · Phase 3

Conditions studied: Lung Diseases, Interstitial

In brief

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).

Key facts

Study ID

NCT03313180

Run by

Boehringer Ingelheim

People needed

444

Starts

2017-11-27

Expected to finish

2023-01-25

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Los Angeles — Los Angeles, California, United States
• University of California Davis — Sacramento, California, United States
• University of California San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• University of Florida College of Medicine — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Tulane University Hospital and Clinic — New Orleans, Louisiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Medical Center-New York Presbyterian Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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