Phase 2
Completed N=198
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)
Source: ClinicalTrials.gov NCT01170065 ↗Enrolled (actual)
198
Serious AEs
71.2%
Results posted
Jun 2019
Primary outcomePrimary: Annual Rate of Decline in Forced Vital Capacity (FVC) — -129.0; -137.5; -132.9 milliliters per year (mL/ yr)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Rate of Decline in Forced Vital Capacity (FVC) |
-129.0; -137.5; -132.9 | — |
| SECONDARY Overall Survival |
37.4; 46.8; 66.2 | — |
| SECONDARY Progression-Free Survival |
9.6; 3.5; 12.2 | — |
| SECONDARY Annual Rate of Decline in Haemoglobin Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Decrease |
-0.4; -0.3; -0.2 | — |
| SECONDARY Percentage of Patients With at Least One Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation |
13.5; 19.8; 20.0 | — |
| SECONDARY Incidence of Patients With at Least One Acute IPF Exacerbation Over Time |
6.1; 7.6; 7.8 | — |
| SECONDARY Time to First Acute IPF Exacerbation |
67.7; 68.6; 73.5 | — |
| SECONDARY Percentage of Patients With at Least One Adverse Events (AEs), With Investigator Defined Drug-Related AEs, AEs Leading to Discontinuation of Trial Drug, Serious AEs |
100.0; 99.2; 97.1; 70.3; 65.9; 54.3 | — |
Eligibility Criteria
Inclusion criteria
- Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
- Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
- Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
Exclusion criteria
- Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
- Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
- Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.
Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
- Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
- Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
- Known or suspected active alcohol or drug abuse.
- Patient not compliant in previous trial, with trial medication or trial visits.
Data sourced from ClinicalTrials.gov (NCT01170065). 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.