Yichang

Researchers are evaluating the efficacy and safety of two drugs, QL1206 and Prolia4, in postmenopausal women with osteoporosis who are at high risk of fractures. This multicenter, randomized, double-blind study aims to compare these treatments to understand their effects on bone health. It is a Phase 3 trial sponsored by Qilu Pharmaceutical Co., Ltd., focusing on women aged 50 to 85 years with specific bone density measurements and risk factors for fractures. Participants receive either QL1206 or Prolia4 denosumab injections at a dose of 60 mg. These injections are given subcutaneously once every 6 months, for a maximum of two doses during the trial. The study groups are randomly assigned and masked so that neither participants nor researchers know which treatment is given. This design helps provide a clear comparison of the two drugs. During the study, participants will have their bone mineral density BMD measured at the lumbar spine at the start and after 12 months to assess changes. Researchers will monitor safety and treatment effects throughout the trial. Women who join will be asked to attend scheduled visits for injections and assessments. The study is expected to continue until January 2027, providing detailed information on these treatments impact on osteoporosis in this population.

Psoriasis is a chronic, recurring inflammatory disease influenced by genetics and environmental factors, marked by skin lesions that can affect multiple organs. Researchers are evaluating the effectiveness of different treatments chosen by patients in real-world clinical settings, comparing phototherapy, traditional systemic therapies, and biologics among Chinese psoriasis patients. This observational study aims to gather real-world evidence under routine care without intervention. Patients diagnosed with psoriasis by dermatologists choose their preferred treatments, which may include phototherapy, traditional systemic drugs, or biologics. The study does not assign treatments but observes outcomes as patients follow their chosen therapies. Data collection is supported through a phone application called Psoriasis New World, and the study includes multiple centers. Participants will be assessed regularly for treatment effectiveness using measures such as the Psoriasis Area and Severity Index PASI, Physician and Investigator Global Assessments, Body Surface Area affected, and Dermatology Life Quality Index. Adverse events and laboratory tests, including liver function, will be monitored throughout up to 12 months. The primary outcome is the percentage of patients achieving complete skin clearance PASI 100 at 6 months, with additional follow-up evaluations at 12 months.

Researchers are evaluating the long-term treatment of liver fibrosis in patients with chronic viral hepatitis B. This Phase IIIb extension trial builds on a previous randomized, double-blind, placebo-controlled study that assessed hydronidone capsules. The aim is to assess how effective and safe hydronidone capsules are over an extended period in managing liver fibrosis progression and reducing clinical endpoint events related to liver disease. Participants receive either hydronidone capsules or placebo capsules three times daily, with each dose consisting of three capsules taken half an hour before meals. Both groups also receive entecavir antiviral therapy once daily, or an alternative antiviral if entecavir is unsuitable. The treatment period in this extension trial lasts for five years, continuing the original protocol from the prior Phase III study. Throughout the study, participants undergo regular assessments including clinical laboratory tests every six months, evaluation of liver enzymes ALT and AST, hepatitis B viral load measurement, and transient elastography to monitor liver stiffness. The researchers track the cumulative incidence of clinical endpoint events over five years to evaluate treatment outcomes. The study also allows some flexibility in the frequency of examinations to improve participant compliance while maintaining at least yearly evaluations.

Researchers are studying the effects of Lecanemab treatment in patients under 65 years old with early-onset familial Alzheimers disease who have a family history of the condition. This observational study aims to understand how genetic and hereditary factors influence the treatments impact on cognitive function and disease progression. The study is sponsored by RenJi Hospital and focuses on patients diagnosed with Alzheimers disease or mild cognitive impairment related to Alzheimers. Participants will receive Lecanemab at a dose of 10 mg per kg every two weeks for 18 months. During this period, they will undergo various assessments including cognitive tests, PET and MRI scans, blood and fluid tests, and whole genome sequencing. These evaluations will be conducted at baseline, 9 months, and 18 months to monitor changes in brain function and disease markers. Throughout the study, participants will be closely monitored through clinical and imaging assessments, cognitive evaluations, and biomarker analyses. The primary outcome measured is the change in the Clinical Dementia Rating-Sum of Boxes CDR-SB score over time. Secondary outcomes include changes in amyloid levels, cognitive scores, brain imaging results, and speech information. The total participation duration is 18 months, during which safety and efficacy data will be collected.

Researchers are studying patients with osteoporotic fractures to find better prevention and treatment methods for refractures. This project involves registering patients for follow-up studies to collect epidemiological data and conducting prospective treatment studies. It aims to explore effective treatment strategies through randomized controlled trials and to develop warning models using biomarkers and new imaging technologies to predict osteoporotic refractures. Participants receive either denosumab alone or a sequential treatment starting with teriparatide followed by denosumab. Denosumab is given as a 60mg subcutaneous injection every six months for 24 months. Teriparatide is administered as a daily 20ug subcutaneous injection for either 6 or 12 months before switching to denosumab, which continues until the 24th month. These treatment plans are part of a multicenter randomized controlled trial. During the study, participants will be monitored for new vertebral fractures and changes in bone mineral density BMD at the lumbar spine, total hip, and femoral neck over 12 and 24 months. Blood tests will measure biomarkers related to bone turnover at several time points. Researchers will also track patients adherence to treatment and assess cost-effectiveness. Follow-up includes evaluation of new fractures at various sites and safety monitoring throughout the 24-month treatment period.