NCT02538536已完成2 期
A Phase 2, Open-label, Single Arm, Exploratory, Observational Study to Evaluate the Safety and Tolerability of PBI-4050 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 主要终点
- Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
研究概览
简要总结
This is a Phase 2, open-label, single-arm study of the safety and tolerability of PBI-4050 800 mg daily oral administration in 40 adult patients with IPF.
详细描述
This Phase 2 multi-centre study will be performed by 6 Canadian sites. It is an open-label, single-arm study in patients with Idiopathic Pulmonary Fibrosis (IPF) aged 40 years and older.
The duration of study participation is approximately 20 weeks for each patient and comprises 6 study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is an adult aged 40 years or older
- •Patient has signed written informed consent.
- •Patient has been diagnosed of IPF according to the most recent guideline on IPF diagnosis and management released by American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Association (ALAT).
- •Female patients of childbearing potential must have a negative urine pregnancy test and agree to use adequate birth control from screening throughout the study and for 30 days after the last study drug administration.
- •If a male patient has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method throughout the study and for 30 days after the last study drug administration.
排除标准
- •Patient has a known diagnosis of a respiratory disorder other than IPF.
- •Substantial emphysema on high resolution computer tomography (HRCT) with degree of emphysema greater than fibrosis.
- •Patient is an active smoker.
- •Patient has evidence of active infection.
- •Patients currently has or has a history of cancer, except basal cell carcinoma or squamous cell carcinoma of the skin.
- •Patient has a concurrent medical or psychological condition that, in the investigator's opinion, may compromise the patient's ability to participate in the study or give informed consent, or may complicate the evaluations of the study drug.
- •Patient is receiving another investigational treatment for IPF at screening and/or plans to receive an investigational treatment for IPF during the current study.
- •Patient has chronic hepatitis or significantly elevated liver enzyme levels, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × upper limit of normal (ULN) or total bilirubin above ULN.
- •Female patient who is pregnant, breast-feeding, or planning a pregnancy during the course of the study.
- •Woman of childbearing potential who is unwilling to use adequate birth control throughout the duration of the study.
- •Patient has participated in an investigational clinical trial during the last 4 weeks.
研究组 & 干预措施
PBI4050
Experimental
Four 200 mg capsules (total 800 mg) administered orally, once daily.
干预措施: PBI4050 (Drug)
结局指标
主要结局
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
时间窗: 4 months
次要结局
- Change from baseline on pulmonary function tests(3 months)
- Change from baseline in imaging of thorax(3 months)
- Change from baseline on biomarkers(3 months)
研究者
相似试验
已完成
2 期
Study to Evaluate the Safety and Tolerability of PBI-4050 in Type 2 Diabetes Patients With Metabolic SyndromeMetabolic SyndromeType 2 DiabetesNCT02562573Liminal BioSciences Ltd.24
终止
2 期
Open-Label Rollover Study of PBI 4050 in Subjects With Alström SyndromeAlström SyndromeNCT03184584Liminal BioSciences Ltd.10
尚未招募
1 期
9MW2821 Combined With Toripalimab Injection in Subjects With Local Advanced or Metastatic Urothelial CancerAdvanced Urothelial CarcinomaNCT06079112Mabwell (Shanghai) Bioscience Co., Ltd.100
已完成
2 期
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate CancerProstate CancerNCT00667862Novartis Pharmaceuticals35
招募中
2 期
Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast CancerHER-2 Negative Breast CancerNCT05398861Henan Cancer Hospital79