Stepney

Researchers are investigating the effects of subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adults with knee osteoarthritis (OA) pain. This Phase 3, randomized, double-blind, placebo-controlled study aims to evaluate changes in knee pain and function. The study will enroll approximately 466 participants who meet specific clinical and radiographic criteria for knee OA and have experienced pain despite prior treatments. Participants will be randomly assigned to receive either PPS at a dose of 2 mg/kg or placebo via subcutaneous injections twice weekly for 6 weeks. The study includes a 7-week screening period, followed by the 6-week treatment phase, and a 52-week follow-up period, totaling up to 64 weeks of participation. An interim analysis will be conducted after about half of the participants complete Day 112, with final analysis after all complete Day 404. Throughout the study, participants will attend visits twice weekly during treatment and every 4 to 6 weeks during follow-up. Researchers will assess knee pain using a daily pain rating scale and monitor changes from baseline up to Day 112. Safety and treatment effects will be evaluated through clinical exams, laboratory tests, and imaging as needed. Participants must adhere to stable non-pharmacologic treatments and limit use of certain medications during the trial.

Researchers are working on the ETHOS II Project to improve care for people with hepatitis C virus (HCV) in drug treatment clinics and needle and syringe programs (NSPs) across New South Wales and Australia. The project aims to create a framework for better HCV screening and treatment services in these settings nationally. It is a collaborative effort involving multiple health and research organizations, focusing on individuals with a history of injecting drug use or those receiving opioid substitution therapy. The study involves an intervention that includes on-site HCV RNA testing, liver fibrosis assessment, and helping participants connect to care to increase the use of direct-acting antiviral therapy for HCV. Participants will undergo procedures such as Hepatitis C testing, fibroscan, questionnaires, and clinical assessments during "campaign days." A sub-study will invite 550 participants to provide blood samples to evaluate new diagnostic tests for chronic HCV infection. The project also includes interviews with policy makers, clinicians, and patients to understand challenges in HCV care, and the development of an education and training program to improve workforce skills and HCV care quality. Participants will be recruited from drug treatment clinics, general practices, and NSP programs. They will complete surveys and may consent to link their data with health databases for ongoing study. The main outcome measured is the number of participants starting anti-HCV treatment each year for up to three years. Researchers will monitor participant health records and follow up through medical record reviews, ensuring thorough tracking of treatment initiation and care engagement throughout the study duration.