Overview

This trial is active, not recruiting.

Condition pulmonary fibrosis
Treatments bibf 1120
Phase phase 2
Target VEGF
Sponsor Boehringer Ingelheim
Start date June 2010
End date October 2016
Trial size 198 participants
Trial identifier NCT01170065, 1199.35, 2009-013788-21

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Low dose BIBF 1120 once daily
bibf 1120
Low dose BIBF 1120 once daily
(Experimental)
Low dose BIBF 1120 twice daily
bibf 1120
Low dose BIBF 1120 twice daily
(Experimental)
Intermediate dose BIBF 1120 twice daily
bibf 1120
Intermediate dose BIBF 1120 twice daily
(Experimental)
High dose BIBF 1120 twice daily
bibf 1120
High dose BIBF 1120 twice daily

Primary Outcomes

Measure
Forced vital capacity decline
time frame: 3 years average

Secondary Outcomes

Measure
Overall survival
time frame: 3 years average
Progression free survival
time frame: 3 years average
Diffusing capacity of the lung for carbon monoxide (DLco) decrease
time frame: 3 years average
Frequency of Idiopathic Pulmonary Fibrosis (IPF) acute exacerbation
time frame: 3 years average
Physical examination
time frame: at 1year, 2 years, 3 years
Frequency of Adverse Events (AEs), frequency of serious AE and AE that may lead to drug discontinuation
time frame: at 1year, 2 years, 3 years
Time to first Idiopathic Pulmonary Fibrosis (IPF) acute exacerbation
time frame: up to 3 years
Vital signs (BP, PR)
time frame: at 1year, 2 years, 3 years
Weight
time frame: at 1year, 2 years, 3 years
Clinically significant changes in liver transaminases (AST,ALT)
time frame: at 1year, 2 years, 3 years
Clinically significant changes in gamma-GT
time frame: at 1year, 2 years, 3 years
Clinically significant changes in alkaline phosphatase (PA)
time frame: at 1year, 2 years, 3 years
absolute and relative change from baseline in FVC values (mL and % predicted)
time frame: 3 years average
Clinically significant changes in total bilirubin
time frame: at 1 year, 2 years, 3 years

Eligibility Criteria

Male or female participants at least 40 years old.

Inclusion criteria: 1. 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. 2. 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 3. Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial) Exclusion criteria: 1. 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. 2. Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks. 3. 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. 4. 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). 5. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc). 6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy. 7. Known or suspected active alcohol or drug abuse. 8. Patient not compliant in previous trial, with trial medication or trial visits.

Additional Information

Official title A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.