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 - ND

Phase 1

• Conditions: Idiopathic Pulmonary Fibrosis; MedDRA version: 9.1Level: LLTClassification code 10021240

• Registration Number: EUCTR2009-013788-21-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-26
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1.Patient with a primary diagnosis of IPF (according to the 2000 ATS/ERS criteria ), who are willing to continue trial medication. 2. Written informed consent signed prior to entry into the study, in accordance with ICHGCP and local law 3. Completion of 1199.30 study and still under treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis.;Secondary Objective: The effects of long term treatment with BIBF 1120 on survival;Primary end point(s): The primary endpoint is Forced Vital Capacity decline (slope of decline between study entry and end of treatment)