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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effectiveness and safety of two drugs, QL1206 and Prolia®, in treating postmenopausal women with osteoporosis who are at high risk of fractures. This Phase 3, multicenter, randomized, and double-blind study compares these treatments to better understand their impact on bone health in this population. Participants receive either QL1206 or Prolia® through subcutaneous injections of 60 mg every six months, for up to two doses during the trial. Both treatments are given on the same schedule, allowing for direct comparison of their safety and efficacy in managing osteoporosis. Throughout the study, researchers will monitor participants' bone mineral density in the lumbar spine at baseline and after 12 months. This measurement will help determine changes in bone strength. The study also includes ongoing safety assessments to ensure participant well-being during the trial.
Actively Recruiting
Researchers are conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.
Actively Recruiting
Researchers are conducting a Phase IIIb extension trial to study long-term treatment with hydronidone capsules in patients with chronic viral hepatitis B who have liver fibrosis. Liver fibrosis currently lacks effective chemical or biological treatments, and the study aims to evaluate the safety and effectiveness of hydronidone capsules in reducing fibrosis severity and preventing clinical endpoint events such as cirrhosis, liver cancer, or liver-related complications. This trial follows a previous Phase III randomized, double-blind, placebo-controlled study. Participants receive either hydronidone capsules or placebo capsules three times daily, each dose containing 3 capsules, for a total daily dose of 270 mg of hydronidone in the treatment group. Both groups also receive entecavir antiviral therapy once daily at 0.5 mg, or an alternative antiviral as decided by the investigator if entecavir is unsuitable. Medications are taken half an hour before meals. Treatment and observation continue for 5 years to assess long-term outcomes. During the study, participants undergo clinical laboratory tests including routine ALT and AST every 6 months or as appropriate, HBV DNA testing, hepatitis B assessments, and transient elastography to monitor liver status. The frequency and types of examinations may be adjusted to improve adherence but will not be reduced more than once per year. The main outcome measure is the cumulative incidence of clinical endpoint events over 5 years. Safety and treatment effects will be closely monitored throughout the extended treatment period.
Actively Recruiting
Researchers are evaluating the effects of Lecanemab treatment in people under 65 years old who have early-onset familial Alzheimer's disease and a family history of Alzheimer's. This observational study focuses on how genetic and hereditary factors may influence the treatment's effectiveness in this specific group. Participants must have a diagnosis of mild cognitive impairment or mild Alzheimer's disease confirmed by clinical criteria and specific brain or fluid tests. Participants will receive Lecanemab at a dose of 10 mg/kg every two weeks for 18 months. During this time, they will undergo various assessments including cognitive tests, PET and MRI scans, blood and fluid tests, and whole genome sequencing. The study aims to monitor changes over the treatment period and understand how the medication works in real-world settings. Throughout the study, participants will be regularly evaluated with cognitive assessments at the start, 9 months, and 18 months. Researchers will closely track changes in cognitive function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Safety and tolerability will also be monitored. Overall, participants will be involved in a detailed and ongoing evaluation to better understand the benefits and effects of Lecanemab over time.
Actively Recruiting
Researchers are investigating effective prevention and treatment strategies for osteoporotic refractures in patients with new fractures. This study includes registration and follow-up studies to gather epidemiological data, as well as a prospective treatment study using randomized controlled trials. It also aims to establish warning models for osteoporotic refractures through biomarker and imaging biomarker research using multi-omics and new imaging technologies. The treatment study compares two approaches: one group receives 60 mg of Denosumab by subcutaneous injection, and the other group receives Teriparatide treatment followed sequentially by Denosumab. This multicenter randomized controlled trial evaluates the efficacy of sequential Denosumab after 6 months of Teriparatide compared with Denosumab alone in reducing the risk of osteoporotic fractures. Participants will be monitored for up to 24 months, with the main outcomes being the incidence of new vertebral fractures and the rate of change in bone mineral density at the lumbar spine. Researchers will collect clinical data, imaging, and biomarker information to assess treatment effects and safety. The study includes careful follow-up to track fracture occurrence and changes in bone health over time.