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

NCT01170065 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2019-06-06

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-25
Primary Completion
2016-09-26
Completion
2016-09-26

Countries

  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • Portugal
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170065 on ClinicalTrials.gov