A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim1 site in 1 country20 target enrollmentSeptember 2011

ConditionsPulmonary Fibrosis

InterventionsNintedanib Pirfenidoneone

DrugsNintedanib Pirfenidoneone

Overview

Phase: Phase 2
Intervention: Nintedanib
Conditions: Pulmonary Fibrosis
Sponsor: Boehringer Ingelheim
Enrollment: 20
Locations: 1
Primary Endpoint: Incidence of Overall Adverse Events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31).

Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

October 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

All patients

Intervention: Nintedanib

All patients

Intervention: Pirfenidoneone

Outcomes

Primary Outcomes

Incidence of Overall Adverse Events

Time Frame: First drug administration until end of treatment, up to 5 years

Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.

Secondary Outcomes

Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.(First drug administration until end of treatment, up to 5 years)
Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years)
Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.(Week 234)
Annual Rate of Decline in Forced Vital Capacity (FVC).(Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years)