This is a phase III, single-arm, open-label, multicenter study to assess the safety of HSK31858 in non-cystic fibrosis bronchiectasis (NCFBE) participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
669
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
Yixing People's Hospital, Yixing, Jiangxi Recruiting
Yixingcun, Jiangxi, China
RECRUITINGAE
Occurrence of adverse events
Time frame: week 96
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
score from 0 to 100
Time frame: week 96
Change from Baseline(Screening) in 24-hour Sputum Weight and Sputum purulence score
score from 0 to 8
Time frame: week 96
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.