A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 51
- 试验地点
- 28
- 主要终点
- Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
Ubenimex is being developed for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group 1) to improve exercise capacity and delay clinical worsening.
This study is a Phase 2, open-label, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001.
详细描述
This study is a Phase 2, open-label, multicenter, extension study to evaluate long-term safety and efficacy of ubenimex in patients with PAH (WHO Group 1) who complete Study EIG-UBX-001 (Study EIG-UBX-001 is a Phase 2, randomized, double-blind, placebo-controlled clinical trial) and meet the eligibility criteria for Study EIG-UBX-002. The primary objective for this study is:
- to obtain long-term safety and tolerability data for ubenimex (150 mg administered three times daily [TID]) in patients with PAH (WHO Group 1).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have completed Study EIG-UBX-001 through Week
- •In the opinion of the Principal Investigator, has been generally compliant with study requirements during Study EIG-UBX-
- •Agrees to use a medically acceptable method of contraception throughout the entire study period.
- •Willing and able to comply with scheduled visits, treatment plans, and laboratory tests and other study procedures.
排除标准
- •Is pregnant or lactating.
- •Concurrent regular use of another leukotriene pathway inhibitor.
- •Any reason that, in the opinion of the investigator, precludes the patient from participating in the study.
- •Any condition that is unstable or that could jeopardize the safety of the patient and his/her compliance in the study
- •A serious uncontrolled medical disorder/condition that in the opinion of the investigator would impair the ability of the patient to receive protocol therapy
- •An ongoing, drug-related, serious adverse event (SAE).
- •Significant/chronic renal insufficiency.
- •Transaminases (alanine transaminase, aspartate transaminase) levels >3 × upper limit of normal (ULN) and/or bilirubin level >2 × ULN.
- •Absolute neutrophil count <1500 mm
- •Hemoglobin concentration <9 g/dL at Screening.
研究组 & 干预措施
ubenimex
ubenimex capsules 150 mg three times a day (TID), administered orally, minimum of 24 weeks for all patients.
The maximum anticipated time an individual patient will participate will vary because treatment will continue until the last patient enrolled has received at least 24 weeks of open-label treatment.
干预措施: ubenimex (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events (TEAEs)
时间窗: At least 24 weeks of open-label treatment with ubenimex followed by 4 weeks follow-up
Number of Patients with TEAEs collected for all patients and recorded on the Adverse Event Case Report Form
次要结局
未报告次要终点