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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the effects of subcutaneous injections of pentosan polysulfate sodium PPS compared with placebo in adults experiencing knee osteoarthritis OA pain. This randomized, double-blind, placebo-controlled phase 3 study aims to measure changes in pain and function over a treatment and follow-up period. The study involves participants with knee OA who have not responded to certain existing therapies, and the research is sponsored by Paradigm Biopharmaceuticals Ltd. Participants will be randomly assigned to receive either PPS or a placebo via subcutaneous injections twice weekly for 6 weeks. The study timeline includes a 7-week screening period, a 6-week treatment period, and a 52-week follow-up. Approximately 466 adults will be enrolled, and an interim analysis will occur after half of the participants complete Day 112, with final analyses conducted after all complete Day 404. Throughout the study, participants will visit the study center twice weekly during treatment and approximately every 4 to 6 weeks during follow-up. They will undergo assessments of knee pain using daily pain scores, function evaluations with the WOMAC index, quality of life questionnaires, and imaging tests including MRI and X-rays. Researchers will monitor safety through adverse event tracking and clinical tests. Total participation may last up to 64 weeks.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating ways to improve hepatitis C virus HCV care in drug treatment clinics and needle and syringe programs in New South Wales and across Australia. The ETHOS II Project aims to develop a framework to establish HCV screening and treatment programs in these settings nationally. This collaborative research involves several health organizations and focuses on people with a history of injecting drug use or those receiving opioid substitution therapy. The study includes an intervention called campaign days where participants receive hepatitis C screening, liver fibrosis assessments using fibroscans, and clinical assessments. Participants also complete surveys and may consent to link their data with population databases. A sub-study involves collecting blood samples from some participants to evaluate new diagnostic tests for chronic HCV infection. Additionally, interviews with policymakers, clinicians, and patients will explore barriers to HCV care, and an education program will be developed to improve workforce knowledge and care quality. Participants will be recruited from drug treatment clinics, general practitioners with high case loads, and needle and syringe programs. They will undergo hepatitis C testing, fibroscans, clinical assessments, and complete questionnaires during the campaign days. Researchers will track how many participants start anti-HCV treatment each year for up to three years. The study also includes follow-up through medical record reviews to monitor outcomes and improve treatment access and delivery.