A Study to Assess the Safety of HSK31858 in Participants With Non-Cystic Fibrosis Bronchiectasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HSK31858, tablet.
- Who it may be relevant to
- Registry conditions: Non-cystic Fibrosis Bronchiectasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase 3 Single-arm, Open-label, Multicenter Study to Assess the Safety of HSK31858 in Participants With Non-cystic Fibrosis Bronchiectasis
Overview
This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
Interventions
- Drug HSK31858, tablet
HSK31858 is a novel inhibitor of DPP1 developed by Hisco Pharmaceutical and can reduce pulmonary exacerbations over a 52-week treatment period in patients with non-cystic fibrosis bronchiectasis
Primary outcome measures
- AE [Time frame: week 96]
Secondary outcome measures (4)
- Frequency of pulmonary exacerbations [Time frame: week 96]
- Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1) [Time frame: week 96]
- Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire [Time frame: week 96]
- Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score [Time frame: week 96]
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-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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Yixing People's Hospital, Yixing, Jiangxi Recruiting — Yixingcun
Identifiers
NCT: NCT07616375 · HSK31858-302