A study to review the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.
- Conditions
- Health Condition 1: null- Systemic Sclerosis associatedInterstitial Lung Disease (SSc-ILD)
- Registration Number
- CTRI/2018/03/012529
- Lead Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
1. AST, ALT > 3 x ULN
2. Bilirubin > 2 x ULN
3. Creatinine clearance <30 mL/min
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is the incidence (number and % of patients) of overall adverse events <br/ ><br>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 Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable