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

CompletadoFase 2ClinicalTrials.gov

ID: NCT01170065Tipo: INTERVENTIONALInicio: 25 de jun de 2010Fin estimado: 26 de sept de 2016

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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.
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).

Intervenciones

drug

BIBF 1120

Intermediate dose BIBF 1120 twice daily

drug

BIBF 1120

High dose BIBF 1120 twice daily

drug

BIBF 1120

Low dose BIBF 1120 twice daily

drug

BIBF 1120

Low dose BIBF 1120 once daily

Ubicaciones

INSARES

Mendoza, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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