2023-506334-75-00招募中3 期
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
GB002 Inc.64 个研究点 分布在 15 个国家目标入组 128 人开始时间: 2024年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 64
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To evaluate the long-term safety and tolerability of seralutinib in subjects with PAH
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Phase 3 study
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects must have completed a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
- •Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) at Enrollment visit before first administration of seralutinib. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required, and results must be negative.
- •WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of seralutinib; acceptable methods include hormonal contraception (oral contraceptives – provided stable dose, patch, implant, or injection), intrauterine devices, or other form of highly effective contraception. Female subjects must refrain from egg donation throughout this period.
- •Women of nonchildbearing potential (WONCBP), classified by one of the following: a. Surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, tubal ligation, Falope® rings, clips, or bands; segmental destruction of the fallopian tubes with electrocoagulation; suture ligation, a microinsert such as the Essure® system, or hysterectomy). b. Evidence of post-menopausal status. Women will be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and have luteinizing hormone (LH), follicle stimulating hormone (FSH), and estradiol levels in the post-menopausal range at the Enrollment visit.
- •Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of seralutinib. Male subjects must refrain from sperm donation throughout this period.
- •Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. "
排除标准
- •Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor’s MM (or designee).
- •Have any other condition or reason that, in the opinion of the Investigator would prohibit the subject from participating in the study.
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
次要结局
- 1. Changes in distance achieved on the six-minute walk test (6MWT), (Δ6MWD)
- 2. Changes in NT-proBNP
研究者
Conor O'Donovan
Scientific
GB002 Inc.
研究点 (64)
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