The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is the annual rate of decline in FVC (expressed
in mL over 52 weeks)
Secondary outcome
Change from baseline in SGRQ total score at 52 weeks (expressed in points)
time to first acute exacerbation (days)
For other secundary endpoints please refer to TP page 36 and 37.
Background summary
Idiopathic Pulmonary Fibrosis is a chronic disease of unknown aetiology that is
characterized by progressive fibrotic destruction of the lung, resulting in
disabling dyspnea. Up to now there is no registered treatment in The
Netherlands for this fatal disease, except lung transplantation. BIBF 1120 has
been studied for the treatment of IPF in large randomized, placebo controlled
trials, and recently completed phase II. In phase II BIBF 1120 150 mg bid
showed a positive effect on lung function compared to placebo. Also incidence
of acute exacerbations was decreased and quality of life improved. BIBF 1120 is
also being studied in oncology.
Study objective
The objective of the trial is to confirm efficacy and a favorable benefit-risk
ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared
to placebo.
Study design
double blind, placebo controlled, randomized, 52 weeks.
Intervention
twice daily, 1 capsule BIBF 1120, 150 mg, per os. Or twice daily, 1 placebo
capsule per os.
Study burden and risks
Pulmonary function testing (FEV1 en FVC): 10 x
physical examination standard: 10 x
Blood sampling:12 x
Sampling for PK: 2 x 1 sample 1 x on visit 4 and 1 x on visit 7
ECG: 5 x
Pregnancy testing (urine): 10 x
Patient questionnaires: 5 x
Dlco: 3 x.
Comeniusstraat 6
Alkmaar 1817 MS
NL
Comeniusstraat 6
Alkmaar 1817 MS
NL
Listed location countries
Age
Inclusion criteria
Written informed consent, Age ><= 40 years; IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 5 years; Dlco (corrected for Hb): 30%-79% predicted of normal; FVC * 50% predicted of normal.
Exclusion criteria
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 8weeks of visit 1.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-024252-29-NL |
| CCMO | NL35599.100.11 |
| Other | nog niet bekend |