NCT04816604进行中（未招募）2 期
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
Gossamer Bio USA, Inc.55 个研究点 分布在 7 个国家目标入组 74 人开始时间: 2021年4月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 55
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type of Subject and Disease Characteristics
- •Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit.
- •Treatment with standard of care PAH disease-specific background therapies (stable dose).
- •Informed Consent
- •Review and signature of an IRB-approved informed consent form.
排除标准
- •Medical Conditions
- •Persistent and clinically significant systemic hypertension or hypotension.
- •Interval history of newly developed left-sided heart disease.
- •Potentially life-threatening cardiac arrhythmia with an ongoing risk.
- •Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
- •Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- •History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
- •Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose.
- •Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
- •Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
- •Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study.
- •Diagnostic Assessments
- •Chronic renal insufficiency
- •Hemoglobin (Hgb) concentration <8.5 g/dL.
- •Absolute neutrophil count (ANC) < 1x 10^9/L.
- •Platelet count <50 x 10^9/L.
- •Prior Therapy
- •Use of inhaled prostanoids.
- •Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
- •Chronic use of any prohibited medication.
- •NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
GB002 (seralutinib)
Experimental
GB002 (seralutinib) inhaled orally twice per day (BID)
干预措施: Generic Dry Powder Inhaler (Device)
GB002 (seralutinib)
Experimental
GB002 (seralutinib) inhaled orally twice per day (BID)
干预措施: GB002 (seralutinib) (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: From first dose of study drug up to 80 months or availability of commercial product
次要结局
- Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)(Baseline, up to 80 months or availability of commercial product)
研究者
研究点 (55)
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