Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Fibrosis
In brief
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate. In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo. Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data. Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.
Key facts
- Study ID
- NCT01335464
- Run by
- Boehringer Ingelheim
- People needed
- 515
- Starts
- 2011-04-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2016-07-25
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >= 40 years;
- IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
- Combination of High Resolution Computerized Tomography (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
You may not qualify if…
- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 1.5 x Upper Limit of Normal (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;
Where it is running
- 1199.32.10029 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States
- 1199.32.10013 Boehringer Ingelheim Investigational Site — Phoenix, Arizona, United States
- 1199.32.10005 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
- 1199.32.10022 Boehringer Ingelheim Investigational Site — Danbury, Connecticut, United States
- 1199.32.10025 Boehringer Ingelheim Investigational Site — Newark, Delaware, United States
- 1199.32.10023 Boehringer Ingelheim Investigational Site — Weston, Florida, United States
- 1199.32.10001 Boehringer Ingelheim Investigational Site — Council Bluffs, Iowa, United States
- 1199.32.10028 Boehringer Ingelheim Investigational Site — Wichita, Kansas, United States
- 1199.32.10016 Boehringer Ingelheim Investigational Site — Minneapolis, Minnesota, United States
- 1199.32.10024 Boehringer Ingelheim Investigational Site — New Brunswich, New Jersey, United States
- 1199.32.10019 Boehringer Ingelheim Investigational Site — New York, New York, United States
- 1199.32.10004 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
- 1199.32.10020 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
- 1199.32.10002 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
- 1199.32.10033 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
- 1199.32.10008 Boehringer Ingelheim Investigational Site — Providence, Rhode Island, United States
- 1199.32.10015 Boehringer Ingelheim Investigational Site — Nashville, Tennessee, United States
- 1199.32.10034 Boehringer Ingelheim Investigational Site — Shelbyville, Tennessee, United States
- 1199.32.10009 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
- 1199.32.10018 Boehringer Ingelheim Investigational Site — McKinney, Texas, United States
- 1199.32.10021 Boehringer Ingelheim Investigational Site — Falls Church, Virginia, United States
- 1199.32.10003 Boehringer Ingelheim Investigational Site — Lynchburg, Virginia, United States
- 1199.32.10038 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
- 1199.32.61001 Boehringer Ingelheim Investigational Site — Camperdown, New South Wales, Australia
- 1199.32.10007 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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