GB002 在成人肺动脉高压 (PAH) 受试者中的开放标签扩展研究
一项评估口服吸入 GB002 治疗 WHO 第 1 组肺动脉高压 (PAH) 的长期安全性和有效性的开放标签扩展研究
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Berlin、德国
- DRK Kliniken Berlin
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Giessen、德国
- Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V
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Hanover、德国、30625
- Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule
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Heidelberg、德国、69126
- Thoraxklinik-Heidelberg gGmbH
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Regensburg、德国、93053
- Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg
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Prague、捷克语、128 08
- Všeobecná fakultní nemocnice v Praze
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Le Kremlin-Bicêtre、法国、94270
- AP-HP Hôpital de Bicêtre
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Tasmania
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Hobart、Tasmania、澳大利亚、7000
- Royal Hobart Hospital
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Victoria
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Fitzroy、Victoria、澳大利亚、3065
- St. Vincent's Hospital Melbourne
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California
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Sacramento、California、美国、95817
- University of California, Davis Medical Center
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Santa Barbara、California、美国、93105
- Medical Corporation
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Florida
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Jacksonville、Florida、美国、32224
- Mayo Clinic
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Weston、Florida、美国、33331
- Cleveland Clinic Florida
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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Kentucky
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Louisville、Kentucky、美国、40202
- Norton Pulmonary Specialists
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Massachusetts
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Boston、Massachusetts、美国、02111
- Tufts Medical Center
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Nebraska
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Omaha、Nebraska、美国、68198
- University of Nebraska Medical Center
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New York
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New York、New York、美国、10016
- NYU Langone Health
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New York、New York、美国、10065
- New York Presbyterian Hospital - Weill Cornell Medicine
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Rochester、New York、美国、14642
- University of Rochester Medical Center
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Ohio
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Columbus、Ohio、美国、43210
- The Ohio State University Wexner Medical Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73112
- INTEGRIS Baptist Medical Center, Inc.
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Texas
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Houston、Texas、美国、77030
- Houston Methodist Hospital
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah Health
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Cambridge、英国、CB2 OAY
- Royal Papworth Hospital NHS Foundation Trust
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London、英国
- Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited
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Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
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Santander、西班牙、39008
- Hospital Universitario Marqués de Valdecilla
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Type of Subject and Disease Characteristics
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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.
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Treatment with standard of care PAH disease-specific background therapies (stable dose).
Informed Consent
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Review and signature of an IRB-approved informed consent form.
Exclusion Criteria:
Medical Conditions
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Persistent and clinically significant systemic hypertension or hypotension.
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Interval history of newly developed left-sided heart disease.
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Potentially life-threatening cardiac arrhythmia with an ongoing risk.
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Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
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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.
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History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
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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.
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Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
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Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
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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
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Chronic renal insufficiency
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Hemoglobin (Hgb) concentration <8.5 g/dL.
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Absolute neutrophil count (ANC) < 1x 10^9/L.
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Platelet count <50 x 10^9/L.
Prior Therapy
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Use of inhaled prostanoids.
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Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
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Chronic use of any prohibited medication.
NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：GB002 (seralutinib)
GB002 (seralutinib) inhaled orally twice per day (BID) |
Capsule containing GB002 (seralutinib) Generic dry powder inhaler for GB002 (seralutinib) delivery |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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治疗中出现紧急不良事件的参与者人数
大体时间：从第一剂研究药物起长达 80 个月或商业产品上市
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从第一剂研究药物起长达 80 个月或商业产品上市
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)
大体时间：Baseline, up to 80 months or availability of commercial product
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Change in the distance achieved on the 6MWT (Δ6MWT) |
Baseline, up to 80 months or availability of commercial product
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合作者和调查者
调查人员
- 研究主任：Robert Roscigno、Gossamer Bio USA, Inc.
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.