Anshun

Researchers are conducting a prospective, multi-center observational study in China to better understand drug-induced liver injury DILI. The study aims to explore the clinical features, identify the drugs or herbs causing DILI, assess patient outcomes, and discover new serum markers. The goal is to develop and validate a prognostic model incorporating these novel markers to improve prediction of patient prognosis in China. Participants will be grouped into a modeling group to help build a predictive model for DILI outcomes, and a validation group to test the accuracy of this model. The study collects long-term data to establish and verify these prognostic tools. No experimental treatments are given as this is an observational cohort study. During the study, researchers will monitor participants for key outcomes such as death, liver transplantation, and acute liver failure over one year, as well as chronic DILI and recovery over two years. Data will be collected through regular clinical assessments and laboratory tests. This long-term follow-up will help improve understanding of DILI prognosis and validate new serum biomarkers. Participants will be involved over extended periods to ensure comprehensive outcome measurement.

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 a standardized full-course extracorporeal membrane oxygenation ECMO management pathway for adults with moderate-to-severe acute respiratory distress syndrome ARDS in China. The study aims to address challenges in ECMO care, such as inconsistent clinical practices, low weaning success, and high complication rates. It focuses on creating a reproducible and evidence-based management strategy to improve the quality and outcomes of ECMO treatment nationwide. The study includes developing a multidisciplinary consensus-based ECMO management pathway covering all stages from assessment and initiation to maintenance, complication prevention, weaning, rehabilitation, and follow-up. Patients treated before pathway implementation receive usual care based on local protocols, while those treated after follow the standardized pathway with individualized adjustments allowed. The study uses a real-world, before-and-after design conducted across multiple centers. Participants undergo ECMO treatment as part of their care, with data recorded on key parameters and deviations from the pathway through an intelligent platform. Regular multidisciplinary reviews analyze outcomes, process barriers, and adverse events to enable continuous pathway improvement. The primary outcome measured is 90-day all-cause mortality after ECMO initiation. Secondary outcomes include mortality at 28 days, liberation from mechanical ventilation, ICU and hospital mortality and length of stay, respiratory support needs, and ECMO-related complications. The study runs from screening through treatment and follow-up with continuous data feedback until February 2030.

This research aims to evaluate Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection FRSW107 as a preventive treatment in men aged 12 to 65 with severe Hemophilia A, a condition characterized by a deficiency of Factor VIII. The study focuses on assessing the efficacy, safety, immune response, quality of life, and pharmacokinetic properties of this treatment in patients who have previously received therapy for severe Hemophilia A. Participants will receive FRSW107 either as part of a pharmacokinetic PK subgroup or a non-PK subgroup. Subjects in the PK subgroup will receive single and multiple doses of 50 IUkg at specified visits, with blood samples collected to analyze drug behavior in the body. Based on PK data, individualized prophylactic dosing will be adjusted to maintain Factor VIII activity above 1%, with recommended doses between 25 to 50 IUkg every three days. Those not in the PK subgroup will receive a fixed prophylactic dose within this range. In case of breakthrough bleeding, dosing adjustments will be made as needed. Throughout the 6-month study period, participants will be monitored regularly to record bleeding episodes, joint health status, quality of life, dosing patterns, and pharmacokinetic outcomes. Safety and immune responses will be evaluated, including detailed blood tests and questionnaires. The primary outcome is the annualized bleeding rate, with secondary outcomes covering multiple measures of bleeding control, treatment effectiveness, and patient well-being. The entire study is conducted under medical supervision with ongoing assessments to ensure participant safety and treatment adherence.

Researchers are evaluating the use of recombinant human coagulation factor VIII-Fc fusion protein FRSW107 as an on-demand treatment for males aged 12 to 65 years with severe hemophilia A, a condition marked by a congenital deficiency of factor VIII causing bleeding. The study aims to assess the effectiveness, safety, and immune response related to FRSW107 treatment, as well as its pharmacokinetic profile and potential exposure-response relationship in previously treated patients. Participants will receive FRSW107 as needed, within a recommended dose range of 20-50 IUkg, for a treatment period lasting up to 6 months. This single-group study involves administering the drug to control bleeding episodes when they occur, without a comparator group. The treatment is given through infusion, and dosing is based on the occurrence of bleeding events during the study period. Throughout the study, participants will undergo various assessments including measurement of haemostatic effectiveness over 6 months, evaluation of factor VIII activity, joint health scores, and monitoring for adverse events, inhibitor development, and immune responses. Researchers will collect data on the number of infusions and dosing required per bleeding episode. Safety and efficacy will be closely monitored, with follow-up and data collection continuing for the full six months of treatment.