A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on annual Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)

• Conditions: Idiopathic Pulmonary Fibrosis; MedDRA version: 14.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-024251-87-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 646

Inclusion Criteria

1.Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry into the study (and prior shipment of HRCT/biopsy to reviewer) 2.Patient aged >= 40 years at visit 1. 3.IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline (in press) for diagnosis and management, within 5 years of visit 2. 4.Chest HRCT performed within 12 months of visit 2. 5.Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF. 6.Dlco (corrected for Hb [visit 1]): 30%-79% predicted of normal at visit 2 7.FVC >= 50% predicted of normal at visit 2
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Laboratory parameters from visit 1 have to satisfy entry criteria as shown below. Visit 2 laboratory results will be available only after randomization. In case at visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains in the trial. The justification for decision needs to be documented. -Laboratory parameters (visit 1) 1.AST, ALT > 1.5 x ULN. 2.Bilirubin > 1.5 x ULN. -Lung function (visit 2) 3.Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 0.7). 4.In the opinion of the Investigator, patient is likely to have lung transplantation during study (but being on transplantation list is acceptable for participation). -Other diseases 5.Cardiac disease a)Myocardial infarction within 6 months of visit 2. b)Unstable angina within 1 month of visit 2. 6.Bleeding risk a)Known genetic predisposition to bleeding. b)Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin etc), or high dose antiplatelet therapy. Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 I.U. s.c. per day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy) is not excluded. c)History of hemorrhagic CNS event within 12 months of visit 2. d)Any of the following within 3 months of visit 2: i)Haemoptysis or haematuria. ii)Active gastro-intestinal bleeding or ulcers. iii)Major injury or surgery. 7.Thrombotic risk a)Known inherited predisposition to thrombosis. b)History of thrombotic event (including stroke and transient ischemic attacks) within 12 months of visit 2. c)Coagulation parameters: International normalised ratio (INR) > 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by > 50% of institutional ULN. 8.Known hypersensitivity to the trial drug or its components. 9.Other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial. 10.Life expectancy for disease other than IPF < 2.5 years (Investigator assessment). -General exclusion criteria 11.Previous treatment with BIBF 1120 (except short term treatment of up to four weeks). 12.Other investigational therapy (participation in research trial) received within 8 weeks of visit 1. 13.NAC, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1. 14.Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1. 15.Surgical procedures (describe) planned to occur during trial period. 16.Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control. 17.Sexually active males not committing to using condoms during the course of the study (except if their partner is not of childbearing potential) and 3 months after end of treatment. 18.Active alcohol or drug abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).;Secondary Objective: -To assess the patient's perception of his/her disease, and the time to IPF exacerbation. -To investigate respiratory and overall survival, as well as causes of mortality. -To assess safety and tolerability.;Primary end point(s): The primary endpoint is the annual rate of decline in FVC.