Non-cystic Fibrosis Bronchiectasis
Conditions
Keywords
non-cystic fibrosis bronchiectasis
Brief summary
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
DRUGHSK31858, 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
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE | week 96 | Occurrence of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of pulmonary exacerbations | week 96 | — |
| Change from Baseline(Screening) in forced expiratory volume in 1 second (FEV1) | week 96 | — |
| Change from Baseline in the Respiratory Symptoms Domain Score of the Quality of Life (QOL) Bronchiectasis questionnaire | week 96 | score from 0 to 100 |
| Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score | week 96 | score from 0 to 8 |
Countries
China
Contacts
CONTACTGuan Wei Jie
Outcome results
None listed