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โ† Trials
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A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis

RecruitingPhase 3Ages 18 Years - anyAllHaisco Pharmaceutical Group Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮฒ-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.
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What it tests

  • HSK31858, tablet
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Where

1 site
Yixing People's Hospital, Yixing, Jiangxi Recruiting
Yixingcun, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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