CTRI/2013/01/003290已完成3 期
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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •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
- •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
研究者
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