A study to review the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis.

Phase 3

Not yet recruiting

• Conditions: Systemic Sclerosis associatedInterstitial Lung Disease (SSc-ILD)

• Registration Number: CTRI/2018/03/012529
• Lead Sponsor: Boehringer Ingelheim India Pvt Ltd

Brief Summary

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



The primary objective of this trial is to assess the long-term safety of nintedanib treatment in patients with Systemic Sclerosis associated Interstitial Lung Disease who have completed (did not prematurely

discontinue trial medication) the phase III parent trial SENSCISTM (1199.214).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 1.Patients who completed the SENSCISTM trial per protocol and did not permanently discontinue blinded treatment.
• Signed and dated written informed consent in accordance with 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.
• A list of contraception methods meeting these criteria is provided in the patient information.

Exclusion Criteria

• AST, ALT > 3 x ULN 2.
• Bilirubin > 2 x ULN 3.
• Creatinine clearance <30 mL/min 4.
• Clinically relevant anaemia at investigators discretion.
• 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 – 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 investigator’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	Endpoint Assessment through out the course of the study. Final Assessment at the end of the study.
over the course of this extension trial.	Endpoint Assessment through out the course of the study. Final Assessment at the end of the study.

Secondary Outcome Measures

Name	Time	Method
Not Applicable	Not Applicable

Trial Locations

Locations (9)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Delhi, DELHI, India

Asthma Bhawan; 🇮🇳 Jaipur, RAJASTHAN, India

B.J. Medical College and Sasoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Care Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Getwell Hospital & Research Institute; 🇮🇳 Nagpur, MAHARASHTRA, India

M. S. Ramaiah Medical College and Hospitals; 🇮🇳 Bangalore, KARNATAKA, India

Nizams Institute of Medical Sciences; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Postgraduate Institute of Medical Education and Research, Chandigarh (PGIMER); 🇮🇳 Chandigarh, CHANDIGARH, India

Sir Gangaram Hospital; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences (AIIMS)

🇮🇳Delhi, DELHI, India

Dr Uma Kumar

Principal investigator

00911126588663

umaakumar@yahoo.co.in