Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

Exclusion Criteria

• •1. AST, ALT \> 1.5 x ULN ;
• •2. Bilirubin \> 1.5 x ULN
• •3. Relevant airways obstruction
• •4. Continuous oxygen supplementation at randomisation (defined as \> 15 hours supplemental oxygen per day).
• •5. Active infection at screening or randomisation.
• •6. Neutrophils \< 1500 / mm3
• •7. International normalised ratio (INR) \> 1.5 and/or Partial thromboplastin time (PTT) \> 1.5 x ULN ;
• •8. Platelets \< 100 000 /mL
• •9. Haemoglobin \< 9.0 g/dL
• •10. In the opinion of the Investigator, patient is likely to have lung transplantation during study
• •11. Life expectancy for disease other than IPF \< 2.5 years (Investigator assessment).
• •12. Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
• •* Myocardial infarction during the previous 6 months
• •* Unstable angina during the previous month
• •13. Other investigational therapy received within 8 weeks prior to screening visit.
• •14. Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrolment.
• •15. Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential).
• •16. Known or suspected active alcohol or drug abuse.
• •17. Bleeding risk : Known inherited predisposition to bleeding, patients who require full-dose anticoagulation, Patients who require full-dose antiplatelet therapy, History of hemorrhagic CNS event within 12 months prior to screening , Any of the following within 3 months prior to screening : Gross / frank haemoptysis or haematuria, Active gastro-intestinal bleeding or ulcers, Major injury or surgery
• •18. Thrombotic risk
• •19. Surgical procedures planned to occur during trial period.
• •20. Coagulopathy
• •21. Uncontrolled systemic arterial hypertension
• •22. known hypersensitivity to lactose or any component of the study medication