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)

Phase 3

Completed

• Conditions: idiopathic pulmonary fibrosis - lung fibrosis of unknown origin; 10038716

• Registration Number: NL-OMON37976
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy endpoint is the annual rate of decline in FVC (expressed<br /><br>in mL over 52 weeks)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change from baseline in SGRQ total score at 52 weeks (expressed in points)<br /><br>time to first acute exacerbation (days)<br /><br><br /><br>For other secundary endpoints please refer to TP page 36 and 37.</p><br>