An open-label extension trial to assess the long term safety of nintedanib in patients with *Systemic Sclerosis associated Interstitial Lung Disease* (SSc-ILD)
- Conditions
- Systemic sclerosis associated lung fibrosis. Scar formation in the lungs caused by systemic sclerosis.1002496710011063
- Registration Number
- NL-OMON53112
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Patients who completed the SENSCISTM trial or 1199-0340 per protocol and did
not permanently discontinue blinded treatment, 2. Signed and dated written
informed consent in accordance with ICH-GCP and local legislation prior to
admission to the trial, 3. Women of childbearing potential1 must be ready and
able to use highly effective methods of birth control for 28 days prior to and
3 months after nintedanib administration. , See protocol section 3.3.2
1. AST, ALT > 3 x ULN, 2. Bilirubin > 2 x ULN, 3. Creatinine clearance < 30
mL/min, 4. Clinically relevant anaemia , 5. Bleeding risk, any of the following:
a. Known genetic predisposition to bleeding
b. Patients who require:
i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
antagonists, direct thrombin inhibitors, heparin, hirudin)
ii. High dose antiplatelet therapy.
c. Hemorrhagic central nervous system (CNS) event after completion of the
parent trial SENSCISTM
d. Any of the following after last treatment of SENSCISTM:
i. Haemoptysis or haematuria
ii. Active gastro-intestinal bleeding or GI - ulcers
iii. Gastric antral vascular ectasia (GAVE)
iv. Major injury or surgery.
e. 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., 6. New major thrombo-embolic events developed after
completion of the parent trial SENSCISTM:
a. Stroke;
b. Deep vein thrombosis;
c. Pulmonary embolism;
d. Myocardial infarction., 7. Major surgery performed within the next 3 months,
8. Time period > 12 weeks between last drug intake in SENSCISTM and Visit 2 of
this trial., Further criteria apply, see protocol section 3.3.3.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the incidence (number and % of patients) of overall<br /><br>adverse events over the course of this extension trial.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable. </p><br>