NCT01170065

Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug. The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF). As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.

Conditions

• Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	BIBF 1120	Intermediate dose BIBF 1120 twice daily
DRUG	BIBF 1120	High dose BIBF 1120 twice daily
DRUG	BIBF 1120	Low dose BIBF 1120 twice daily
DRUG	BIBF 1120	Low dose BIBF 1120 once daily

Timeline

• Start date: 2010-06-25
• Primary completion: 2016-09-26
• Completion: 2016-09-26
• First posted: 2010-07-27
• Last updated: 2019-06-06
• Results posted: 2019-06-06

Locations

57 sites across 21 countries: Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Portugal, Russia, Spain, United Kingdom