Status:Active, not recruiting
Keywords:BIBF 1120 , IPF , Idiopathic Pulmonary Fibrosis
Sub Specialty:Pulmonary Fibrosis
To confirm efficacy and a favorable benefit/risk ratio for the drug BIBF 1120 in the treatment IPF at a dose of 150 mg twice daily compared to a placebo for 52 weeks.
The primary objective is to demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity.
Other main objectives will be to assess the participant's perception of his/her disearse, and the time to IPF exacerbation.
Principle Investigator: Mary Scholand
Principle Department: Pulmonary
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 1.
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
1. AST, ALT > 1.5 ULN
2. Bilirubin > 1.5 ULN
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
Myocardial infarction within 6 months of visit 2.
Unstable angina within 1 month of visit 2.
6. Bleeding risk
Known genetic predisposition to bleeding.
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.
History of hemorrhagic CNS event within 12 months of visit 2.
Any of the following within 3 months of visit 2:
• Haemoptysis or haematuria.
• Active gastro-intestinal bleeding or ulcers.
• Major injury or surgery.
7. Thrombotic risk
Known inherited predisposition to thrombosis.
History of thrombotic event (including stroke and transient ischemic attacks) within 12 months of visit 2.
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 Statement)
11. Previous treatment with BIBF 1120 (except for 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 > 15 mg/day or equivalent received within 2 weeks of visit 1.
14. Pirfenidone, azathioprine, cyclophosphamide, cyclosphorine 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 (one barrier and one highly effective non-barrier) for at least one month prior to enrollment (and until 3 months after treatment end).
Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or postmenopausal for at least 2 years.
Highly effective methods of birth control include established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS). A barrier method of contraception includes condom or occlusive cap with spermicidal (foam, gel, film, cream, suppository) or male sterilization (with appropriate postvasectomy documentation of the absence of sperm in the ejaculate).
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.