A 52 weeks, double blind, randomized, placebo-controlled trial evaluating the effect of oral BIBF 1120, 150 mg twice daily, on Forced Vital Capacity decline , in patients with Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary FibrosisMedDRA version: 13.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2010-024252-29-GR
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 485
Age >= 40 years;
IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 5 years;
Combination of HRCT pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF;
Dlco (corrected for Hb): 30%-79% predicted of normal;
FVC = 50% predicted of normal
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
Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN);
Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC < 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 (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months; International normalised ratio (INR) > 2; prolongation of prothrombin time (PT) and partial thromboplastin time
(PTT) by > 50% of institutional ULN);
N-Acetyl Cystein, prednisone > 15mg/day or equivalent received within 2 weeks of visit 1;
Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8
weeks of visit 1.
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.<br>To investigate respiratory and overall survival, as well as causes of mortality.<br>To assess safety and tolerability.;Primary end point(s): Annual rate of decline in FVC (expressed in mL over 52 weeks).
- Secondary Outcome Measures
Name Time Method