A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Guan Wei Jie
- 电话号码:86-13826042052
- 邮箱:battery203@163.com
学习地点
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Jiangxi
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Yixingcun、Jiangxi、中国
- 招聘中
- Yixing People's Hospital, Yixing, Jiangxi Recruiting
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接触:
- Feng Yan Yan
- 电话号码:86-13812558080
- 邮箱:staff622@Yxph.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
1.Voluntarily sign the informed consent form; 2.Had previously participated in the HSK31858-301 study (having completed at least the randomization and having taken the first dose of medication); 3.If long-term treatment with bronchodilators (long-acting β-agonists and/or long-acting muscarinic antagonists) is required, the dose and regimen should remain stable throughout the study period.
4.Women must be post-menopausal, surgically sterile, or using highly effective contraception methods from Day 1 to at least 30 days after the last dose.
5. Males with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
Exclusion Criteria:
1.In the HSK31858-301 study, there were cases of serious adverse events related to the investigational drug or subjects who were assessed by the investigators as requiring permanent discontinuation of the treatment.
2. Any other unstable clinical condition, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, or major physiological dysfunction, that the investigator considers to be (a) likely to affect patient safety throughout the study; (b) Influence the results of the study and its interpretation; (c) impeding the patient's ability to complete the entire study.
3.Pregnancy and lactation. 4.The investigators judged that there were other conditions that were not suitable for participation in the study.
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:HSK31858 40mg
HSK31858 40mg treat for 96-week
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HSK31858是Hisco Pharmaceutical开发的一种新型DPP1抑制剂,可在52周的治疗期内减少非囊性纤维化支气管扩张患者的肺部病情加重
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
AE
大体时间:week 96
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Occurrence of adverse events
|
week 96
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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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Frequency of pulmonary exacerbations
大体时间:week 96
|
week 96
|
|
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Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1)
大体时间:week 96
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week 96
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Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire
大体时间:week 96
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score from 0 to 100
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week 96
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Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
大体时间:week 96
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score from 0 to 8
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week 96
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
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
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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