Health Condition 1: null- Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)
Conditions
Interventions
Intervention1: Nintedanib: 1 x 150mg capsule b.i.d. (total daily dose 300mg).
1x 100mg capsule b.i.d.
(total daily dose 200mg).
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who completed the SENSCISTM trial 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 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. A list of contraception methods meeting these criteria is provided in the patient information.
Exclusion criteria
Exclusion criteria: 1. AST, ALT > 3 x ULN 2. Bilirubin > 2 x ULN 3. Creatinine clearance 4. Clinically relevant anaemia at investigators discretion. 5. Bleeding risk, like a. Known genetic predisposition to bleeding as per investigator b. Patients who require -Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vit K antagonists,DTI, heparin, hirudin) -High dose antiplatelet therapy. -Hemorrhagic CNS event after completion of main study 6.Any of the following after last treatment of the parent trial -Haemoptysis or haematuria -Active GI bleeding or GI â?? ulcers -Major injury or surgery (PI judgement) 7.Coagulation parameters: INR >2, prolongation of PT & PTT by >1.5 x ULN at Visit 1 8. New major thrombo-embolic events developed after completion of the parent trial: -Stroke -DVT -PE -MI 9.Major injury or surgery (major according to the investigatorâ??s assessment) done within the next 3 months 10. Time period > 12 weeks between last drug intake of the parent trial SENSCISTM & randomization visit of this study 11. A disease or condition which in the opinion of investigator may put the patient at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence (number and % of patients) of overall adverse events over the course of this extension trial.Timepoint: Endpoint Assessment through out the course of the study. Final Assessment at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt Ltd.
Outcome results
None listed