FindTrial
Sign In

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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-024252-29-FI
Enrollment
485
Registered
2011-02-04
Start date
2011-04-01
Completion date
Unknown
Last updated
2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis MedDRA version: 12.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis

Interventions

Product Name: BIBF 1120 Product Code: BIBF 1120 Pharmaceutical Form: Capsule, soft Current Sponsor code: BIBF 1120 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1

Sponsors

Boehringer Ingelheim
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age >= 40 years; IPF diagnosed, according to most recent ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management, within 5 years; Combination of 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Laboratory parameters (AST, ALT > 1.5 x ULN; Bilirubin > 1.5 x ULN); Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC 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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate a reduction of lung function decline, as measured by a change of the yearly rate of decline of forced vital capacity (FVC).;Secondary Objective: To assess the patient's perception of his/her disease, and the time to IPF exacerbation. To investigate respiratory and overall survival, as well as causes of mortality. To assess safety and tolerability.;Primary end point(s): Annual rate of decline in FVC (expressed in mL over 52 weeks).—

Countries

Finland, Germany, Greece, Netherlands, Portugal, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026