Safety test of HSK31858 in people with non-cystic fibrosis bronchiectasis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, single-arm, open-label, multicenter study evaluating the safety of the tablet HSK31858 in participants with non-cystic fibrosis bronchiectasis. Eligible participants are adults who completed the prior HSK31858-301 trial and meet constraints on bronchodilator use and contraception. The study focuses on safety outcomes over a defined treatment period at participating sites, with follow-up to monitor adverse events and tolerability. The sponsor is Haisco Pharmaceutical, and the study is conducted at Yixing People's Hospital in Jiangxi, China. Exclusion criteria include a history of serious drug-related adverse events in the prior trial or other unstable conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yixing People's Hospital, Yixing, Jiangxi Recruiting
  Yixingcun, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Guan Wei Jie
• Email: battery203@163.com
• Phone: 86-13826042052

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Nebulized CSL787 (inhaled IgG) to reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis

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• Assessing a new treatment for non-cystic fibrosis bronchiectasis

  This study is testing a new treatment called HSK31858 to see if it can help people with non-cystic fibrosis bronchiectasis feel better and have fewer flare-ups.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.