A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
Recruiting
Phase 3Interventional Study
Non-cystic Fibrosis Bronchiectasis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
669 (estimated)
Sponsor
Haisco Pharmaceutical Group Co., Ltd. · Industry
Who this trial is looking for
This trial is looking for individuals with non-cystic fibrosis bronchiectasis. Participants will need to have previously taken part in another study involving the same treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have signed the informed consent form.
I completed the HSK31858-301 study.
My bronchodilator treatment is stable during the study.
I am a post-menopausal woman, surgically sterile, or using effective contraception.
My male partner is using effective contraception if applicable.
You may not be able to join if
I had serious side effects from the study drug in the past.
I have an unstable health condition that could affect my safety.
I am currently pregnant or breastfeeding.
The investigators consider my health conditions unsuitable for the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
Trial Locations
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Eligibility Criteria
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-…
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.
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