EUCTR2009-013788-21-HU进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient with a primary diagnosis of IPF (according to 2000 ATS/ERS criteria), willing to continue trial medication
- •2. written informed consent prior to entry into the study, in accordance with ICH-GCP and local law
- •3. completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 89
排除标准
- •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.
研究者
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