CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 198 enrolled
Drug / intervention
BIBF 1120 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01170065
NCT01170065Phase 2Completed
CompareCT.gov

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

Boehringer Ingelheim·interventional·Posted Jul 27, 2010·Updated Jun 6, 2019

In Brief

A Phase 2 clinical trial evaluating BIBF 1120 for Pulmonary Fibrosis. Completed, enrolled 198 participants across 57 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Fibrosis
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, Ireland, Italy, Mexico, Netherlands, Portugal, Russia, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2010
Enrollment StartJun 25, 2010
Primary CompletionSep 26, 2016
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 15.9 years ago

Interventions

BIBF 1120drug

Intermediate dose BIBF 1120 twice daily

BIBF 1120drug

High dose BIBF 1120 twice daily

BIBF 1120drug

Low dose BIBF 1120 twice daily

BIBF 1120drug

Low dose BIBF 1120 once daily