Hyde Park

Researchers are evaluating additional dosing options of dulaglutide in children and adolescents aged 10 to less than 18 years with Type 2 Diabetes. This phase 3, open-label, multicenter study aims to assess the safety, tolerability, how the drug moves through the body, and effectiveness of dulaglutide at doses of 3.0 mg and 4.5 mg in this pediatric population. Participants have Type 2 Diabetes managed with diet, exercise, metformin, and/or basal insulin. Participants will receive dulaglutide administered subcutaneously at either 3.0 mg or 4.5 mg doses. The study is a single-arm design without a placebo or comparative drug group. The treatment period and follow-up last about 8 months. The study monitors participants throughout this time to evaluate the effects and safety of the dosing options. During the study, researchers will regularly assess participants for any serious adverse events related to the study drug from baseline through week 26. Participants will be monitored for safety, tolerability, and drug levels in the body. The main outcome measure is the number of participants experiencing one or more serious adverse events related to dulaglutide. Overall participation in the study lasts approximately 8 months, including screening and treatment.

This research aims to evaluate the effectiveness and safety of a fixed-dose combination of fluticasone propionate (Fp) and albuterol sulfate (ABS) delivered via an integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS alone in reducing severe clinical asthma exacerbations in patients with asthma. The study also assesses the efficacy of a low dose of Fp/ABS versus ABS and examines the impact on systemic corticosteroid exposure. This is a phase 3 randomized, double-blind, active-controlled trial involving patients diagnosed with asthma for at least one year. Participants will receive either a high dose or low dose of Fp/ABS or ABS alone through oral inhalation powder during a double-blind treatment period lasting a minimum of 24 weeks. The study includes a 2-week screening phase, a 2 to 4-week run-in period, and the treatment phase. Because this is an event-driven study, the total duration for individual participants may extend up to approximately 42 months depending on enrollment timing and study completion. During the study, participants will be closely monitored for time to first severe clinical asthma exacerbation while using the inhaler device. Safety and tolerability will be evaluated throughout the study. Researchers will also track systemic corticosteroid use and overall asthma control. The minimum participation time is 28 weeks, including screening and run-in, with extended monitoring possible based on study events and criteria.

The trial investigates the safety and effectiveness of Voyager's Access Device, called VenaSure, designed to aid cannulation of arteriovenous fistulas (AVFs) in patients undergoing routine hemodialysis. This pivotal, prospective, single-arm, open-label study aims to support FDA clearance by demonstrating the device's ability to facilitate AVF cannulation and assessing its safety over time. The study focuses on patients with vascular access complications related to dialysis treatment. VenaSure is surgically implanted at the access site to provide a target that helps improve long-term cannulation success. After implantation, participants are observed for 6 weeks to allow the implant site to heal. Following this, they continue routine dialysis treatments while being monitored for 36 months. The study will conclude after the final visit when no device-related adverse events are being monitored. Participants will undergo assessments including ultrasound measurements and monitoring of dialysis procedures during the study period. Effectiveness is primarily measured by the device's ability to facilitate AVF cannulation over 6 months, while safety is evaluated for up to 12 months after implantation. The study is expected to last approximately 48 to 60 months from the first enrollment until all data collection is complete.

Researchers are investigating the long-term safety and effectiveness of therapies for people with congenital or acquired non-cancerous blood disorders, including bleeding and clotting disorders and connective tissue disorders with bleeding tendencies. This observational study is being conducted across about 150 sites affiliated with the American Thrombosis and Hemostasis Network (ATHN) and aims to enroll 3,000 participants. It addresses the need for uniform, secure, and unbiased collection of safety and efficacy data over many years, especially as many new therapies have recently been approved but lack long-term data beyond initial trials. Participants will be assigned to one of several disease-specific groups, such as Hemophilia, von Willebrand Disease, Congenital Platelet Disorders, Rare Disorders, Bleeding Not Otherwise Specified, Thrombosis/Thrombophilia, or other Non-Neoplastic Hematologic Conditions. The study includes various arms and modules focused on specific conditions or treatments, including gene therapy and new factor replacement products. Data collection occurs at enrollment, every six months, annually, and as needed, with some modules requiring daily tracking or additional assessments. During the study, participants will undergo detailed evaluations including clinical assessments, laboratory tests, and questionnaires to monitor treatment safety and effectiveness. The study measures outcomes related to bleeding and clotting events and other health indicators over a planned minimum of 15 years. Researchers will track participants’ health status, treatment use, and any complications, aiming to improve understanding and management of these blood disorders over the long term.