Huai An Shi

Chronic hepatitis B virus HBV infection is a major global health issue that can lead to serious liver problems such as cirrhosis, liver cancer, and death. This observational study aims to gather detailed information from a broad group of Chinese patients with chronic HBV infection to better understand the factors that influence disease outcomes. The study involves creating a comprehensive database of clinical, epidemiological, biological, virological, immunologic, and treatment-related data from patients with chronic HBV infection. There are no drug interventions instead, participants are monitored as part of this long-term cohort. Participants will be followed over many years, with researchers tracking outcomes like loss of hepatitis B antigens, development of cirrhosis, liver failure, liver cancer, and mortality. Regular assessments will collect relevant health information to help identify the factors linked to disease progression. The study is planned to continue until 2030, providing extensive long-term data on chronic HBV infection.

Researchers are evaluating the effectiveness and safety of Recombinant Botulinum Toxin Type A YY001 injections for treating upper limb spasticity in adults who have had a stroke. This randomized, double-blind, multi-center phase IIIII study compares YY001 with BOTOX4 and a placebo to better understand treatment options for this condition. Participants will receive a single intramuscular injection of either Recombinant Botulinum Toxin Type A YY001 with a dose of 200-400 units, BOTOX4 with a dose of 200 units, or a placebo prepared with saline. The study includes three groups the experimental group receiving YY001, an active-controlled group receiving BOTOX4, and a placebo-controlled group. Each participant receives only one injection during the treatment period. During the study, participants will be monitored at 1, 4, 8, and 12 weeks after treatment through assessments such as the Modified Ashworth Scale MAS for spasticity, Physicians Global Assessment, and Disability Assessment Scale DAS. Researchers will also track any adverse events and the presence of antibodies to the treatment. The primary outcome is the change in MAS score at week 4. The study lasts at least 12 weeks with ongoing safety and efficacy follow-up.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are evaluating the efficacy, safety, and tolerability of combining elecoglipron and dapagliflozin compared to each drug alone in adults with type 2 diabetes mellitus T2DM who have not achieved adequate control through lifestyle changes or other glucose-lowering medications. This Phase III study aims to better understand how these treatments work together in managing blood sugar levels in this population. Participants are randomly assigned to one of five groups two groups receive elecoglipron at different dose levels combined with dapagliflozin two groups receive elecoglipron at different dose levels combined with a placebo matching dapagliflozin and one group receives dapagliflozin alone with a placebo matching elecoglipron. All medications are taken orally once daily. The treatment period lasts 40 weeks, during which the effects of the drugs on blood sugar and other health measures will be monitored. Throughout the study, participants will have regular assessments of their blood sugar control, body weight, and blood pressure. Researchers will measure changes in Hemoglobin A1c HbA1c, fasting plasma glucose, and self-monitored blood glucose levels. Other outcomes include weight loss and the need for rescue medication. Safety and tolerability will be closely monitored. Participation in the trial lasts for 40 weeks, during which participants will attend scheduled visits for evaluation and medication monitoring.

Researchers are investigating the use of simple imaging methods compared to standard imaging to select stroke patients with anterior large vessel occlusion for thrombectomy treatment. The goal is to see if using simpler imaging techniques like NCCT and CTA is as effective as using more advanced imaging strategies that include CTP and MRI. This trial tests the hypothesis that simple imaging is not worse than the standard approach when it comes to achieving favorable outcomes after treatment. Participants will be randomly assigned to one of two groups one group will be screened using simple imaging methods NCCT and CTA, while the other group will be screened using standard imaging methods that include NCCT-ASPECTS, CTA, and CTP. Both groups will undergo endovascular treatment based on the imaging selection. The study compares these two imaging strategies to determine their impact on treatment decisions and patient outcomes. During the study, researchers will evaluate patients recovery by assessing favorable outcomes at 90 days after endovascular treatment. They will also monitor for safety concerns such as symptomatic intracranial hemorrhage within 48 hours and mortality at 90 days. Participants must be followed for at least 90 days post-treatment to gather these data. The study aims to provide clear information about the best imaging approach for selecting patients for thrombectomy.

Researchers are studying the effectiveness and safety of lebrikizumab in people aged 12 and older who have chronic rhinosinusitis with nasal polyps and are treated with intranasal corticosteroids. This Phase 3 trial compares different dosing schedules of lebrikizumab with a placebo to find out how well it reduces symptoms such as nasal congestion and polyp size over about 18 months. Participants receive lebrikizumab or placebo as subcutaneous injections while continuing their regular intranasal corticosteroid therapy. Adolescents aged 12 to under 18 weighing at least 40 kg will receive open-label lebrikizumab every 2 or 4 weeks. The study includes two experimental lebrikizumab groups with different dosing intervals and a placebo group, all alongside background intranasal corticosteroids. During the study, participants will have regular assessments including symptom severity scores, nasal polyp size measured by endoscopy, sinus imaging, lung function tests, and questionnaires about nasal symptoms and quality of life. Researchers will monitor changes from baseline to week 24 primarily for nasal congestion and polyp scores. Safety and long-term effects will also be observed throughout the study duration of about 18 months.

Researchers are evaluating a new medicine called YL201 compared to the standard chemotherapy chosen by doctors in people with locally advanced or metastatic esophageal squamous cell carcinoma who have stopped responding to first-line treatment. The goal is to see if YL201 works better and is safer. The study is a large, randomized phase III trial involving multiple hospitals and also investigates how YL201 is processed in the body, immune reactions it might cause, and whether certain biological markers can predict its effects. Participants will be assigned to one of two groups one group receives YL201 alone, given as an intravenous infusion on the first day of each 3-week cycle. The other group receives a chemotherapy drug chosen by their doctor, which may be paclitaxel, docetaxel, or irinotecan, each given intravenously on specific schedules every 3 weeks. The study treatment continues as planned, with monitoring throughout the treatment period. During the study, participants will undergo regular evaluations including scans and laboratory tests to measure how well the treatments are working and to monitor side effects. The main outcome researchers will track is overall survival for up to about 36 months. They will also assess progression-free survival, response rates, duration of response, and adverse events during this time. The study will last until the end of 2028, with ongoing monitoring and data collection.

Researchers are evaluating the long-term safety and effectiveness of multiple treatments using recombinant botulinum toxin type A YY001 injections for adults with upper limb spasticity caused by stroke. This phase III, open-label, multicenter study focuses on adults aged 18 to 75 who have unilateral hemiplegia and functional difficulties related to upper limb spasticity. Participants will receive multiple intramuscular injections of YY001 prepared by reconstituting the powder with saline. Each treatment dose ranges from 200 to 400 units. The study tracks the impact of repeated treatments over time, monitoring safety and treatment response. Throughout the study, participants will be regularly assessed for adverse events, muscle spasticity changes using the Modified Ashworth Scale, functional improvements via the Disability Assessment Scale, and antibody development up to 48 weeks. Evaluations occur at specified intervals after each treatment to understand the treatments ongoing effects and safety profile.

Researchers are evaluating the effects and safety of efgartigimod given intravenously in adults with primary immune thrombocytopenia ITP, a condition where the immune system attacks platelets. This phase 3 clinical trial aims to determine how well efgartigimod controls platelet counts compared to a placebo during a 24-week double-blinded treatment period. The study is sponsored by argenx and includes follow-up periods to monitor ongoing effects and safety. Participants will be randomly assigned in a 21 ratio to receive either efgartigimod IV or placebo IV during the double-blinded treatment period. After this, all participants will receive efgartigimod IV during a first 52-week open-label treatment phase, followed by an optional second 52-week open-label phase. After completing these treatment periods, participants will have an approximately 8-week follow-up while off the study drug, with total study participation lasting up to 138 weeks. During the study, participants will have regular blood tests to measure platelet counts and assess disease control. Researchers will track the number of weeks participants maintain platelet counts above specified levels and monitor any bleeding events or adverse effects. Safety is closely observed throughout the trial, including antibody responses to the drug. Participants will have scheduled visits and assessments throughout treatment and follow-up to gather comprehensive data on efgartigimods impact.