NCT01417156

Safety and PK Study of BIBF 1120 in Japanese Patients With IPF: Follow up Study From 1199.31(NCT01136174)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Nintedanib	150 mg bid
DRUG	Pirfenidoneone	Existing treatment

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-08-16
• Last updated: 2017-03-06
• Results posted: 2017-03-06

Locations

4 sites across 1 country: Japan