Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

Phase 3

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Nintedanib

• Registration Number: NCT01619085
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-06
• Study First Submitted: 2012-06-06
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Primary Completion: 2017-07-05
• Results First Submitted: 2018-07-02
• Results First Submitted QC: 2018-07-02
• Results First Posted: 2018-07-26
• Study Completion: 2021-02-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 752

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	Nintedanib	patient to receive a capsule containing Nintedanib twice a day

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs)	From first drug administration until end of treatment period + 28 days, in total up to 56.3 months plus 28 days.	This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.

Trial Locations

Locations (170)

Jasper Summit Research, LLC; 🇺🇸 Jasper, Alabama, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

University of California; 🇺🇸 Torrance, California, United States

Sansum Clinic; 🇺🇸 Santa Barbara, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Western Connecticut Medical Group; 🇺🇸 Danbury, Connecticut, United States

Pulmonary Assoc of Stamford; 🇺🇸 Stamford, Connecticut, United States

Cleveland Clinic; 🇺🇸 Weston, Florida, United States

Georgia Clinical Research; 🇺🇸 Austell, Georgia, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Scroll for more (160 remaining)