Fuchu

Researchers are evaluating the long-term safety of subcutaneous guselkumab in children with moderately to severely active ulcerative colitis, Crohn's disease, or juvenile psoriatic arthritis. This Phase 3, open-label study aims to monitor the safety of this treatment over an extended period in a pediatric population. Participants will receive guselkumab through subcutaneous injections. The study includes those who have completed the initial pediatric guselkumab dosing and have benefited from continued therapy as judged by their doctor. The study focuses on long-term treatment, with safety assessed by tracking adverse events for up to 6 years and 9 months. During the study, children will be regularly monitored for treatment-emergent adverse events. Parents or guardians will provide consent, and children able to understand will give assent. Researchers will collect data to assess safety throughout the treatment period, ensuring careful observation of participants' health and responses to guselkumab.

Researchers are evaluating how well vortioxetine tablets at doses of 10 mg/day or 20 mg/day work compared to placebo tablets for treating depression symptoms in Japanese teenagers aged 12 to 17 years who have been diagnosed with Major Depressive Disorder (MDD). This phase 3 clinical trial aims to assess the drug's effectiveness, safety, and how the body processes the medication in this pediatric population. Participants will be randomly assigned to receive either vortioxetine or a placebo once daily for 14 weeks. The study includes an initial screening period of up to 15 days to determine eligibility, followed by the 14-week treatment phase. After completing treatment, there is a 4-week period dedicated to monitoring any side effects. Throughout the study, participants will visit the clinic 13 times for assessments and medication administration. During the study, participants will undergo evaluations including the Children Depression Rating Scale Revised version (CDRS-R) to measure changes in depression symptoms from baseline to week 14. Other assessments include safety monitoring and pharmacokinetics. Researchers will also collect information on side effects during and after treatment. The total time commitment for participants is about 20 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the effectiveness of TEV-56286, taken orally, for treating adults with Multiple System Atrophy (MSA), a rare neurological condition. This Phase 2 trial aims primarily to measure changes in patients' symptom severity using the Modified Unified Multiple System Atrophy Rating Scale over 48 weeks. The study also examines other specific effects of TEV-56286 and evaluates its safety and tolerability. Participants will be randomly assigned to receive either TEV-56286 capsules or a matching placebo, both given orally during a 48-week double-blind treatment period. The overall study duration for each participant is about 56 weeks, which includes a screening phase lasting up to 4 weeks and a follow-up visit approximately 4 weeks after treatment ends. The trial is conducted across multiple countries including the US, Israel, Italy, Spain, Germany, France, Japan, and Serbia. During the study, participants will undergo regular assessments to monitor their condition using rating scales specific to MSA symptoms. Researchers will track changes from baseline scores over time to evaluate treatment effects. Safety and tolerability will be closely watched throughout the study and during follow-up visits. The total planned duration of the study is around 27 months.

Researchers are evaluating the early use of a once-daily oral drug called empagliflozin 10 mg in patients hospitalized with acute heart failure (AHF) who are at high risk for serious complications. This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial aims to assess the efficacy and safety of empagliflozin compared to a matching placebo in this patient group. The trial focuses on patients requiring intravenous diuretic therapy and exhibiting specific clinical signs and biomarker levels related to heart failure severity. Participants are randomly assigned to receive either empagliflozin 10 mg once daily or a placebo shortly after hospital admission. Treatment begins within 12 hours of hospital presentation and continues during the hospitalization period. The study excludes patients with very low kidney function, recent use of similar drugs, certain heart conditions, and other specific medical issues to ensure safety and clear evaluation of the drug's effects. During the study, patients will be closely monitored for outcomes including death, rehospitalization for heart failure, worsening heart failure during the hospital stay, and urine output within 48 hours of treatment start. Researchers will use a combined measure called the win ratio to assess these outcomes over 90 days. Participants will undergo clinical evaluations, laboratory tests, and safety assessments throughout the study period to track the drug's impact and monitor for any adverse events.

Researchers are conducting a multicenter, single-arm, non-interventional survey to study the safety of Entresto Tablets or Entresto Granules in pediatric patients with chronic heart failure in Japan. The study focuses on observing these patients in real-world clinical settings and aims to collect information about safety concerns, such as hypotension, hyperkalemia, renal impairment, and dehydration. The observation period lasts for up to 52 weeks after starting treatment. The study involves pediatric patients aged 1 to under 18 years who are receiving Entresto for chronic heart failure for the first time. It monitors the administration of Entresto, including details about accidental use of the granules in capsule-shaped containers. This long-term observation helps researchers understand risk factors related to safety events and the overall status of Entresto use in this young population. Participants will be followed for one year, during which researchers will observe and record any events related to the safety of the medication. The main focus is on tracking occurrences of hypotension, high potassium levels, kidney problems, and dehydration. Safety monitoring includes collecting data on these events and understanding their relationship to Entresto use in children with chronic heart failure.

This research aims to learn about the safety, how the body processes, and how well the study medicine called nirmatrelvir/ritonavir works for treating COVID-19 in children under 18 years old who are not hospitalized but are at risk for severe illness. The study focuses on pediatric patients confirmed to have COVID-19, with early symptoms and risk factors for worsening disease. Participants will receive the study medicine, which is given by mouth, to evaluate its effects. The trial is open-label, meaning both researchers and participants know the treatment being given. The study is designed as a single-arm Phase 2/3 trial conducted at multiple centers. During the study, researchers will measure medicine levels in the blood at specific times to understand drug absorption and processing. They will monitor for any side effects or adverse events up to 34 days after starting treatment. Vital signs and other health indicators will be regularly checked to assess safety and overall health. The total participation period includes treatment and follow-up to gather comprehensive safety and effectiveness data.

Researchers are evaluating the effects of KK8398 on growth in children and adolescents with achondroplasia, a genetic condition affecting bone growth. This Phase 3, open-label, single-arm study aims to measure how KK8398 influences annualized height velocity over 52 weeks of treatment. KK8398 will be given repeatedly to patients aged between 2.5 and 17.5 years who have a confirmed genetic diagnosis of achondroplasia and meet specific developmental criteria. The study involves a single treatment group receiving KK8398 with no placebo or comparator groups. Treatment effects will be assessed after one year of administration. Participants will be monitored for changes in height growth from the start of the study to Week 52. Researchers will track growth rates and collect safety information throughout the treatment period. The total study duration for each participant is 52 weeks, during which height velocity is the primary outcome measure.

This research aims to assess the safety and effectiveness of Fabhalta capsules in patients diagnosed with C3 glomerulopathy, including those who have experienced recurrence after a kidney transplant. The study focuses on real-world clinical practice to better understand how Fabhalta performs in managing this condition. The study involves patients who have already been treated with Fabhalta for C3 glomerulopathy. There are no additional interventions or comparator groups described, as the study is observational and monitors the outcomes of those using Fabhalta. Participants will be followed for up to 360 days, during which researchers will track the number of patients who develop infections. This monitoring helps evaluate the safety profile of Fabhalta over time. No other specific assessments or procedures are detailed in the study information provided.

Researchers are evaluating the safety and effectiveness of surgical aortic valve replacement (SAVR) compared to transcatheter aortic valve replacement (TAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk. This prospective, randomized, controlled, multi-center study aims to determine if SAVR is not inferior to TAVR in terms of death from any cause, stroke, and rehospitalization related to valve procedures within one year after surgery. Participants will be randomly assigned to receive either SAVR or TAVR using commercially available surgical and transcatheter bioprosthetic valves. The study includes follow-up visits at hospital discharge, 30 days after the procedure, and then annually for up to 10 years to monitor outcomes and safety. Both procedures involve valve replacement but differ in their surgical approach. During the study, participants will undergo assessments to track mortality, stroke events, and hospital readmissions related to valve or procedure complications. Researchers will collect clinical data and monitor participants regularly over the long-term follow-up period to evaluate the combined primary endpoint at one year post-procedure and observe ongoing safety and effectiveness.

Researchers are evaluating the effectiveness and safety of a Double-effect kissing balloon technique (W-KBT) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) who have left circumflex artery (LCx) ostium stenosis. This is a prospective, observational, multi-center study focusing on patients with stable angina, non-ST-elevation acute coronary syndrome, or unstable angina who are undergoing percutaneous coronary intervention (PCI). Patients who meet selection criteria will be enrolled and treated under usual care. The PCI procedure involves W-KBT following crossover stenting for the left main trunk to left anterior descending artery direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) as the optimal treatment. Operators will obtain consent before performing PCI and will register cases continuously to assess the technique's efficacy and safety. Participants will undergo PCI with W-KBT, and data will be collected during the procedure to measure procedure success rates. Researchers will monitor major adverse cardiovascular events (MACE) within 12 months after PCI. The study will gather real-world data from multiple centers to evaluate the outcomes and safety of this treatment approach over time.