An open-label extension study of long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 759
- 试验地点
- 9
- 主要终点
- To assess the long-term safety of BIBF 1120
研究概览
简要总结
An open-label extension trial of the long term safety of oral BIBF 1120 in patients with Idiopathic Pulmonary Fibrosis (IPF) . The total number of patients proposed to be recruited in India is 20. First patient is expected to be rolled-over on 31 Jan 2013.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Signed Informed Consent consistent with ICH-GCP and local laws prior to trial participation Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period and performed the follow-up visit.
排除标准
- •AST ALT more than 1.5 fold ULN Patients who completed the parent trial with transaminase values more than 1.5 fold ULN but less than 3 fold ULN are considered eligible Bilirubin more than 1.5 fold ULN Bleeding risk Patients who require fibrinolysis full dose therapeutic anticoagulation eg vitamin K antagonists dabigatran heparin hirudin or high dose antiplatelet therapy Exceptions prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device eg enoxaparin 4000 IU sc per day) and prophylactic use of antiplatelet therapy eg acetyl salicylic acid up to 325 mg per dayor clopidogrel at 75 mg per day or equivalent doses of other antiplatelet therapy Hemorrhagic CNS event gross frank haemoptysis or haematuria active gastrointestinal bleeding or ulcers after completion of the parent trial Coagulation parameters International normalised ratio INR more than 2 prothrombin time PT and partial thromboplastin time PTT more than 150percent of institutional ULN Planned major surgery within the next 3 months including lung transplantation major abdominal or major intestinal surgery New major thromboembolic events developed after completion of the parent trial Stroke Deep vein thrombosis Pulmonary embolism Myocardial infarction Time period more than 12 weeks between Visit 9 of the parent trial and Visit 2 of this study Usage of any investigational drug after completion of the parent trial or planned usage of a specific investigational drug during the course of this trial A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patients ability to participate in this trial Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control one barrier and one highly effective nonbarrier for at least 1 month prior to Visit 2 and or not committing to using it until 3 months after end of treatment Women will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation or postmenopausal for at least two years Highly effective methods of birth control include established use of oral injected or implanted hormonal methods of contraception placement of an intrauterine device IUD or intrauterine system IUS A barrier method of contraception includes condom or occlusive cap with spermicidal foam gel film cream suppository or male sterilization with appropriate postvasectomy documentation of the absence of sperm in the ejaculate Sexually active men not committing to using condoms during participation in the study except if their partner is not of childbearing potential and 3 months after the last intake of BIBF 1120.
结局指标
主要结局
To assess the long-term safety of BIBF 1120
时间窗: To assess the long-term safety (up to approximately 6 years) of BIBF 1120 | treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one | year treatment and the follow-up period in the phase III trials 1199.32 and 1199.34
treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one
时间窗: To assess the long-term safety (up to approximately 6 years) of BIBF 1120 | treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one | year treatment and the follow-up period in the phase III trials 1199.32 and 1199.34
year treatment and the follow-up period in the phase III trials 1199.32 and 1199.34
时间窗: To assess the long-term safety (up to approximately 6 years) of BIBF 1120 | treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one | year treatment and the follow-up period in the phase III trials 1199.32 and 1199.34
次要结局
未报告次要终点