Dataset from 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

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.

本试验旨在为已完成BIBF 1120既往临床试验的特发性肺纤维化（Idiopathic Pulmonary Fibrosis, IPF）患者提供该药物的延续治疗方案。本试验的主要研究目标为明确BIBF 1120用于特发性肺纤维化患者的长期耐受性与安全性特征。作为次要研究目标，本试验将采用开放标签、非随机、非对照的试验设计，探究BIBF 1120长期治疗对患者生存率以及安全性、有效性参数的影响。