Jiaxing

Researchers are evaluating the safety and effectiveness of Ademetionine in adults with obstructive hypertrophic cardiomyopathy oHCM through a multicenter, double-blind, randomized controlled Phase 2 trial. The study aims to understand how Ademetionine affects exercise capacity, heart failure symptoms, heart structure and function, and quality of life in this patient group. Participants will be randomly assigned to receive either Ademetionine or a placebo. The treatment period lasts 16 weeks, during which participants will have follow-up visits every 4 weeks. The study compares the effects of Ademetionine with placebo while monitoring safety and tolerability. Throughout the study, participants undergo assessments including cardiopulmonary exercise testing CPET, evaluations of heart function by echocardiography, and quality of life questionnaires. Researchers will closely monitor changes from baseline to Week 16 in exercise capacity and heart function, as well as adverse events. The total study duration for each participant is 16 weeks from baseline.

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 use of Toripalimab combined with neoadjuvant chemotherapy as an adjuvant treatment for triple-negative breast cancer TNBC. This phase II, prospective, single-arm, multi-center clinical trial aims to assess the pathologic complete response PCR rate along with the types and frequency of side effects. Secondary objectives include monitoring disease-free survival, progression-free survival, and objective response rate in participants. The treatment involves two phases of neoadjuvant chemotherapy combined with Toripalimab administered intravenously every three weeks. The first phase includes Epirubicin, Cyclophosphamide, and Toripalimab for six weeks, followed by Albumin-bound Paclitaxel plus Toripalimab for another six weeks. After four treatment cycles, participants undergo radical breast cancer surgery. Postoperative therapy depends on pathology results if PCR is achieved, immunotherapy with Toripalimab continues every three weeks for one year if not, chemotherapy combined with Toripalimab continues. Gene testing on biopsy tissue and blood samples for ctDNA testing are also performed before and after treatment. During the study, participants will have regular assessments including pathology evaluation and monitoring of side effects. Researchers will track treatment response and survival outcomes over two to three years. The total involvement includes neoadjuvant treatment, surgery, postoperative therapy, and follow-up to evaluate treatment effectiveness and safety. Careful monitoring ensures adherence and collection of important biological samples for ongoing analysis.

Researchers are conducting a prospective, multicenter, open-label, randomized controlled trial to compare two treatment strategies for adults with acute myocardial infarction AMI who have mild coronary artery narrowing. The study aims to determine if standard medical therapy alone is not worse than using drug-eluting stent DES implantation combined with standard therapy. This trial will include 2,000 patients with ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation myocardial infarction NSTEMI from multiple centers in China. Participants will be randomly assigned to one of two groups one receiving guideline-recommended standard medical therapy alone, which includes dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other related medications and the other receiving DES implantation plus the same standard medical therapy. The study also includes a functional substudy with 120 participants assessing coronary microvascular dysfunction using pressure wire tests. The enrollment period is planned for 36 months, with a follow-up of at least 12 months after randomization and continued monitoring until study completion. During the study, participants will undergo coronary angiography and assessments of vessel function. Researchers will monitor for target lesion failure TLF, defined as cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, over a median follow-up of 30 months. Additional outcomes include all-cause death, stroke, rehospitalization for heart conditions, and quality of life measures. The study tracks these outcomes through regular follow-up visits to evaluate the safety and effectiveness of the treatment approaches.

Researchers are studying a new lyophilized herpes zoster virus mRNA vaccine in healthy adults aged 40 years and older. The study aims to evaluate the safety and immune response of this vaccine, with Part A focusing on initial safety and immune effects, and Part B aiming to find the best dose and schedule in adults aged 50 and older. This trial is randomized, double-blind, and controlled to ensure accurate assessment of the vaccines effects. Participants receive two doses of the study vaccine with varying dosages and schedules or comparator vaccines including live attenuated vaccine, recombinant zoster vaccine, or placebo. In Part A, all participants get two doses of the mRNA vaccine given 30 or 60 days apart. In Part B, participants are randomly assigned to different doses or comparator vaccines with safety and immune responses monitored throughout. Immune response durability is also checked at several points after vaccination. During the study, participants undergo safety monitoring and immune testing including blood tests for antibody levels and cellular immunity. Researchers record adverse reactions within 30 days after each dose and track serious side effects for up to 12 months. Immune responses are measured at multiple timepoints after vaccination to assess antibody levels and T cell activity. Participants are expected to comply with visits, sample collections, and vaccination schedules throughout the study, which continues with long-term observation of immune persistence.

Researchers are evaluating the effectiveness and safety of Inpegsomatropin injection compared to recombinant human growth hormone rhGH in children with idiopathic short stature ISS. This multicenter, randomized, open-label Phase III trial aims to enroll 300 children with ISS, assessing growth outcomes and safety over a defined period. Participants will be randomly assigned to receive either Inpegsomatropin injection once weekly at 280 micrograms per kilogram or recombinant human growth hormone injection daily at 350 micrograms per kilogram divided into seven doses. The study includes a screening period of up to 12 weeks, followed by a 52-week treatment period and a 5-week post-treatment follow-up. During the trial, children will be monitored regularly for growth velocity, changes in height standard deviation scores, insulin-like growth factor 1 levels, and the ratio of bone age to chronological age. Safety evaluations will also be conducted throughout the study, with the total participation lasting approximately 69 weeks including all phases.

The trial is a multicenter, randomized, open-label, positive-controlled phase III study enrolling 84 girls aged 2 to under 12 years with short stature due to Turner Syndrome TS. The study aims to compare the effectiveness and safety of two growth hormone treatments, Inpegsomatropin-Injection and Givopegsomatropin Solution Injection, to provide evidence supporting the new use of Inpegsomatropin in this population. Participants are randomly assigned in equal numbers to receive either Inpegsomatropin injection at 280 mcgkgweek or Givopegsomatropin solution injection at 200 mcgkgweek. Both treatments are administered subcutaneously once a week for 52 weeks. The study follows a parallel design to assess the comparative outcomes of these two drugs throughout the treatment period. During the study, children will be monitored regularly for growth velocity, changes in height standard deviation scores, insulin-like growth factor 1 levels, and bone age progression. Safety and efficacy will be evaluated at various follow-up points up to week 52. Guardians and participants aged 8 or older will provide informed consent or assent. The total participation time covers the full 52-week treatment and assessment period.