Phase 3
Completed N=752
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Source: ClinicalTrials.gov NCT01619085 ↗Enrolled (actual)
752
Serious AEs
67.9%
Results posted
Jul 2018
Primary outcomePrimary: Incidence of Adverse Events (AEs) — 98.5; 42.6; 68.9; 23.8 Percentage of patients (%)
◆ Published Evidence
Highly cited
239citations · ~34 / year
Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON.
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.
Linked Publications
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Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AEs) |
98.5; 42.6; 68.9; 23.8 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01619085) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.