A clinical trial to study the safety and efficacy of BIBF 1120 at high dose in patients with lung fibrosis because of unknown cause

Phase 3

Completed

• Conditions: Health Condition 1: null- Idiopathic Pulmonary Fibrosis

• Registration Number: CTRI/2011/12/002245
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 485

Inclusion Criteria

Age more than or equal to 40 years

IPF diagnosed according to most recent American Thoracic Society European Respiratory Society Japanese Respiratory Society Latin American Thoracic Association IPF guideline for diagnosis and management within 5 years

Combination of High Resolution Computerized Tomography pattern and if available surgical lung biopsy pattern as assessed by central reviewers are consistent with diagnosis of IPF

Dlco that is corrected for Hb is 30%-79% predicted of normal

FVC more than or equal to 50% predicted of normal

Exclusion Criteria

Aspartate Aminotransferase Alanine Aminotransferase more than 1.5 x Upper Limit of Normal ULN

Bilirubin more than 1.5 x ULN

Relevant airways obstruction that is pre bronchodilator FEV1/FVC less than 0.7

Patient likely to have lung transplantation during study being on transplantation list is acceptable for participation

Myocardial infarction within 6 months

Unstable angina within 1 month

Bleeding risk that is genetic predisposition or fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy or history of hemorrhagic CNS event within 12 months haemoptysis or haematuria or active gastrointestinal bleeding or ulcers or major injury or surgery within 3 months

Thrombotic risk that is inherited predisposition history of thrombotic event including stroke and transient ischemic attacks within 12 months

International normalised ratio more 2, prolongation of prothrombin time and partial thromboplastin time by more than 50 percent of institutional ULN

N-ACetyl Cystein, prednisone more than 15mg per day or equivalent received within 2 weeks of visit 1

Pirfenidone or azathioprine or cyclophosphamide or cyclosporine A received within 8 weeks of visit 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified