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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of HSK31858, a novel DPP1 inhibitor, in adults with non-cystic fibrosis bronchiectasis NCFBE. This phase III, randomized, double-blind, placebo-controlled, multicenter study aims to reduce pulmonary exacerbations in participants who have experienced at least two exacerbations in the past year. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and focuses on a population with confirmed bronchiectasis affecting one or more lung lobes, excluding those with cystic fibrosis or certain other lung diseases. Participants will be randomly assigned to receive either HSK31858 40 mg tablets or a placebo for 52 weeks. The treatment is administered orally once daily. The study includes a placebo comparator group to evaluate the effects of HSK31858 against no active treatment. The trial also requires stable dosing of any long-term bronchodilator therapies during the study period. During the 52-week study, participants will be monitored regularly for pulmonary exacerbations and lung function changes using measures such as forced expiratory volume in 1 second FEV1, sputum weight, sputum purulence, and quality of life assessments specific to bronchiectasis symptoms. Safety will be assessed throughout the trial, and participants will be followed closely to evaluate treatment outcomes and adverse effects. Total participation duration is approximately one year, including screening and treatment.
Actively Recruiting
This trial investigates the safety of HSK31858, a novel drug developed to reduce pulmonary exacerbations in people with non-cystic fibrosis bronchiectasis NCFBE. It is a phase III, single-arm, open-label, multicenter study aiming to evaluate the safety profile of HSK31858 in this patient group. The study is sponsored by Haisco Pharmaceutical Group Co., Ltd. and focuses on participants who have previously been involved in an earlier related study of the drug. Participants will receive HSK31858 at a dose of 40 mg once daily over a 96-week treatment period. This treatment phase is the main part of the study, where the drugs impact on health and lung function will be closely monitored. The study does not involve a comparison group or placebo, and all participants will receive the active drug. During the study, participants will undergo regular evaluations including monitoring of adverse events, lung function tests such as forced expiratory volume in 1 second FEV1, assessment of respiratory symptoms through quality of life questionnaires, and sputum analysis. These assessments will help researchers understand the safety and effects of HSK31858 over nearly two years. The total study duration for each participant corresponds to the 96-week treatment period, with ongoing safety and health monitoring throughout.
Actively Recruiting
Researchers are evaluating normobaric hyperoxia NBO as a treatment for patients who have experienced an acute ischemic stroke and are transferred for endovascular thrombectomy EVT. The study aims to assess the effectiveness and safety of NBO in improving functional outcomes at 3 months after stroke. Stroke is a leading cause of death and disability, and although reperfusion treatments like thrombectomy improve blood flow, less than half of patients achieve favorable recovery. NBO is thought to protect the brain by rescuing hypoxic tissue and reducing damage processes, with advantages such as low cost and easy use. Participants will be randomly assigned to receive either NBO, which involves inhaling 100% oxygen alongside the best medical care, or best medical care alone. The study compares these two groups to see if NBO provides additional benefits. The treatment is given during the acute phase before or during transfer for EVT. The study includes a single-blind design and follows patients for outcomes over time. During the study, participants will have their disability level measured using the modified Rankin Scale at 90 days and one year after randomization. Other assessments include neurological function scores, imaging scans, infarct volume changes, and quality of life questionnaires at various time points. Safety and recovery progress are closely monitored throughout, with follow-up visits to track long-term effects. The total participation duration includes initial treatment and follow-up through one year.