Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II
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
- NCT01335477
- Run by
- Boehringer Ingelheim
- People needed
- 551
- Starts
- 2011-05-01
- 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; 5.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
- 1199.34.10093 Boehringer Ingelheim Investigational Site — Santa Barbara, California, United States
- 1199.34.10077 Boehringer Ingelheim Investigational Site — Stanford, California, United States
- 1199.34.10083 Boehringer Ingelheim Investigational Site — Torrance, California, United States
- 1199.34.10080 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
- 1199.34.10087 Boehringer Ingelheim Investigational Site — South Miami, Florida, United States
- 1199.34.10100 Boehringer Ingelheim Investigational Site — Austell, Georgia, United States
- 1199.34.10075 Boehringer Ingelheim Investigational Site — Chicago, Illinois, United States
- 1199.34.10069 Boehringer Ingelheim Investigational Site — Olathe, Kansas, United States
- 1199.34.10090 Boehringer Ingelheim Investigational Site — Lexington, Kentucky, United States
- 1199.34.10079 Boehringer Ingelheim Investigational Site — Rochester, Minnesota, United States
- 1199.34.10067 Boehringer Ingelheim Investigational Site — Chesterfield, Missouri, United States
- 1199.34.10066 Boehringer Ingelheim Investigational Site — Lebanon, New Hampshire, United States
- 1199.34.10085 Boehringer Ingelheim Investigational Site — Albany, New York, United States
- 1199.34.10092 Boehringer Ingelheim Investigational Site — Jamaica, New York, United States
- 1199.34.10074 Boehringer Ingelheim Investigational Site — Durham, North Carolina, United States
- 1199.34.10088 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
- 1199.34.10070 Boehringer Ingelheim Investigational Site — Portland, Oregon, United States
- 1199.34.10064 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
- 1199.34.10089 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
- 1199.34.10082 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
- 1199.34.10095 Boehringer Ingelheim Investigational Site — Longview, Texas, United States
- 1199.34.10060 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
- 1199.34.10084 Boehringer Ingelheim Investigational Site — Salt Lake City, Utah, United States
- 1199.34.10101 Boehringer Ingelheim Investigational Site — Colchester, Vermont, United States
- 1199.34.10086 Boehringer Ingelheim Investigational Site — San Francisco, California, United States
Full record on ClinicalTrials.gov
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