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An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) This study is in follow-up

General Information

Age Group

Adult

Status

Active

Protocol Number

1199.225

Background Information

This study is being done to evaluate the long-term safety and tolerability of the study drug called Nintedanib in subjects with Systemic Sclerosis and associated Interstitial Lung Disease. Nintedanib has not been approved by the U.S. Food and Drug Administration (FDA) to treat Systemic Sclerosis and associated Interstitial Lung Disease and is experimental for this study. It has been approved by the FDA to treat Idiopathic Pulmonary Fibrosis, a disease similar to Systemic Sclerosis related lung fibrosis.

Offered At

Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road
Falls Church, VA 22042

Principal Investigator

Oksana Shlobin, MD

Eligibility Information

  • Patients who completed the SENSCISTM trial per protocol and did not permanently discontinue blinded treatment
  • Patients willing and able to sign and date the written informed consent prior to admission into trial
  • Women of childbearing potential must be ready and able to use highly effective methods of birth control 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

Ineligibility Information

  • Liver function blood testing (specifically AST and ALT) which are greater than 3 times the upper normal limit
  • Bilirubin blood level greater than 2 times the upper normal limit
  • Clinically relevant anemia at the discretion of the investigator
  • Patients with increased risk of bleeding (such as genetic predisposition, patients requiring fibrinolysis, hemorrhagic central nervous system events, elevated coagulation parameters)
  • New major thrombo-embolic events developed after completion of the parent trial SENSCISTM (ex: stroke, deep vein thrombosis, pulmonary embolism, myocardial infarction)
  • Major surgery scheduled to be performed within 3 months of enrollment
  • Usage of any other investigational drug during this trial
  • Greater than 12 week time period between last drug intake in SENSCISTM and Visit 2 of this trial
  • Any disease or medical condition that, in the opinion of the investigator, may put the patient at risk because of participation in this trial
  • Women who are pregnant, nursing, or plan to become pregnant while in the trial