Idiopathic pulmonary fibrosis MedDRA version: 9.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion 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 6. Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted . 7. PaO2 =55 mmHg (sea level to 1500 m) or 50 mmHg (above 1500 m) room air Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. AST, ALT > 1.5 x ULN at screening 2. Bilirubin > 1.5 x ULN at screening 3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN at screening 8. Platelets < 100 000 /mL at screening 9. Haemoglobin < 9.0 g/dL at screening 10. In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation). 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. Pregant 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 (highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner). Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. 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 (e.g. vitamin K antagonists, heparin, hirudin etc). • Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy. • History of hemorrhagic CNS event within 12 months prior to screening (visit 1). • Any of the following within 3 months prior to screening : o Gross / frank haemoptysis or haematuria o Active gastro-intestinal bleeding or ulcers o Major injury or surgery. 18. Thrombotic risk • Known inherited predisposition to thrombosis. • History of thrombotic event (including stroke and transient ischemic attacks) within 12 months prior to screening 19. Surgical procedures planned to occur during trial period. 20. Coagulopathy. 21. Uncontrolled systemic arterial hypertension. 22. Known hypersensitivity to lactose or any other component of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy and safety of four doses strategies of BIBF 1120 treatment for 12 months compared to placebo in patients with Idiopathic Pulmonary Fibrosis;Secondary Objective: ;Primary end point(s): The primary endpoint is the rate of decline in FVC (expressed in mL per year), evaluated from baseline until 12 month of treatment, compared to placebo | — |
Countries
Belgium, Bulgaria, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed