Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis

Launched by BOEHRINGER INGELHEIM · Aug 9, 2007

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patient \>40 years
• • 2. Written informed consent signed prior to entry into the study
• • 3. IPF diagnosed (according to ATS / ERS criteria) less than 5 years prior to screening visit.
• • 4. HRCT within 12 months of randomisation and biopsy (the latter if needed to fulfil ATS/ERS criteria) centrally reviewed and consistent with diagnosis.
• • 5. FVC\>50 % of predicted value
• Predicted normal values will be calculated according to ESCS (R94-1408):
• Males :
• • FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34
• Females :
• • FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89
• • 6. Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .
• • Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.
• Adjustment for haemoglobin (R06-2002):
• Males :
• • DLCO predicted for Hb = DLCO predicted x (1.7Hb/\[10.22+Hb\])
• Females :
• • DLCO predicted for Hb = DLCO predicted x (1.7Hb/\[9.38+Hb\]) where Hb is expressed in g/dL-1
• • 7. PaO2 \>= 55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air
• 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