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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed Informed Consent consistent with International Conference on Harmonisation-Good Clinical Practices (ICH-GCP) and local laws prior to trial participation.
Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.

Exclusion criteria

Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper Limit of Normal (ULN) (Patients who completed the parent trial with transaminase values > 1.5 fold ULN but < 3 fold ULN are considered eligible)
Bilirubin > 1.5 fold ULN
Bleeding risk
Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
New major thrombo-embolic events developed after completion of the parent trial.
Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.
Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial.
A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients' ability to participate in this trial.
Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it until 3 months after end of treatment.

Treatment and study plan

Nintedanib

Drug

Nintedanib twice a day

Other names: BIBF 1120

Primary outcomes

Incidence of Adverse Events (AEs)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Open-label Extension Trial of the Long Term Safety of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2021
First posted: Jun 14, 2012
Registry last updated: Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed