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Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

This research is focused on patients diagnosed with Atypical Hemolytic-Uremic Syndrome (aHUS). It aims to gather post-marketing safety data for patients treated with the drugs eculizumab or ravulizumab, as well as to monitor the progression of the disease in all participating patients regardless of treatment status. The study is observational and non-interventional, conducted across multiple centers and countries. No specific treatments or interventions are administered as part of this study; rather, it observes patients who have already been treated or untreated with eculizumab or ravulizumab. The study collects data from these patients over time to understand safety outcomes and disease progression. Participants will be followed to record the proportion experiencing certain events over a period of 10 years and the timing of first and subsequent occurrences of these events over 5 years. The study involves gathering clinical information and safety data through routine monitoring. Patients or their guardians provide informed consent and may be asked for assent if applicable. The study tracks long-term outcomes and safety in aHUS patients.

Researchers are investigating treatments for adults with kidney failure who have recently been diagnosed with calciphylaxis, a rare condition affecting 1 to 2 people per 10,000. This Phase 3 global platform trial aims to gather strong evidence on how different treatments impact patients across multiple areas of care. The study uses an adaptive design, allowing changes during the trial, such as adding or removing treatment options and adjusting participant assignments based on ongoing results. The trial starts with two treatment areas: dialysis membrane types and drug therapies. In the drug therapy group, patients receive either Vitamin K1 capsules three times a week after dialysis, Magnesium Citrate tablets three times daily (with timing adjusted on dialysis days), Sodium Thiosulfate injections during the last hour of dialysis three times weekly, or matching placebos. The dialysis membrane group compares two types of dialyzers: high flux and medium cut-off. Participants will be assessed over 12 weeks using the BEAT-Calci Wound Assessment Scale, measuring wound healing progress. The study includes regular monitoring and adaptive sample size updates to determine when enough evidence is collected. The trial continues until clear results show treatment benefits or no effect, with ongoing evaluations to ensure participant safety and treatment effectiveness.

Researchers are conducting a two-part, phase 2b/3 study to evaluate CSL300 (Clazakizumab) in adults with end stage kidney disease (ESKD) undergoing dialysis who have systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes. The study aims to determine the best dose of CSL300 and assess its effects on cardiovascular outcomes and safety in this population. This multicenter, randomized, double-blind, placebo-controlled trial targets patients with elevated inflammation markers and significant health risks due to their conditions. In the first part (phase 2b), the study focuses on finding the appropriate dose of CSL300 compared to placebo. CSL300 is given through intravenous (IV) administration. The second part (phase 3) evaluates the impact of CSL300 on cardiovascular events such as heart attack or cardiovascular death over approximately 5 years, continuing to compare CSL300 to placebo for safety and efficacy. The placebo matches CSL300's excipient content but lacks the active drug. Participants will undergo baseline and regular assessments for inflammation markers like high-sensitivity C-reactive protein (hs-CRP) up to 12 weeks in phase 2b, and long-term monitoring for cardiovascular outcomes in phase 3. The study involves ongoing safety evaluations and efficacy measurements during the entire follow-up period. This comprehensive approach helps researchers understand how CSL300 affects inflammation and cardiovascular health in patients with ESKD on dialysis.

Researchers are comparing two ways of giving PD-1 inhibitor treatment to patients with metastatic melanoma: continuously without breaks, or intermittently with planned breaks. PD-1 inhibitors are a type of immunotherapy that help the immune system fight melanoma. The study aims to find out if intermittent treatment is as effective as continuous treatment in extending patients' lives. This is a Phase 3 trial focused on overall survival over seven years. Participants will receive either intermittent PD-1 inhibitor therapy, where treatment pauses are taken when the melanoma improves, or continuous PD-1 inhibitor therapy without breaks. The study treatments involve government-approved and publicly funded PD-1 inhibitors. The intermittent approach may reduce clinic visits, side effects, and costs if found to be as effective as continuous therapy. During the study, participants will be followed closely with assessments to monitor their disease status and quality of life. They must complete questionnaires in English or French to evaluate health outcomes. Researchers will track overall survival for up to seven years and monitor treatment effects and safety. Patients must be available for treatment and follow-up to ensure complete data collection throughout the study.

Researchers are evaluating the effects of epoetin alfa compared to a placebo in critically ill trauma patients who require mechanical ventilation. This phase III, randomized, double-blind trial aims to reduce death and severe disability six months after injury. The study will enroll 2,500 patients admitted to intensive care units (ICUs) with a primary trauma diagnosis in locations including Australia, New Zealand, Europe, and Saudi Arabia. Trauma can cause serious injuries that may lead to death or long-term disability despite current treatments, and epoetin alfa, a hormone stimulating red blood cell production, may have protective effects beyond this role. Participants will be randomly assigned to receive either epoetin alfa 40,000 IU via a subcutaneous injection or a placebo injection of sodium chloride 0.9%, both given as 1 mL pre-filled syringes. The treatment will be administered during the ICU stay following admission for trauma. The study monitors patients from the time of injury through ICU care and up to six months afterward to assess outcomes. During the study, patients will be closely monitored for survival and disability levels using the WHODAS 2.0 scale at six months after injury. Researchers will track various health parameters, including the severity of disability or death. The study includes detailed assessments during ICU care and a follow-up period to measure the combined proportion of patients who die or experience severe disability. Safety and response to treatment will be carefully evaluated throughout the trial period.

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.

Each year, over 7,000 Australians suffer severe trauma that can cause serious bleeding and poor outcomes. This trauma can disrupt the body's ability to form blood clots, leading to excessive bleeding. Early replacement of clotting factors, especially fibrinogen which helps bind clots together, may improve recovery. This trial, called FEISTY II, is a phase III study comparing two methods of fibrinogen replacement in adults with major trauma and bleeding. The study compares fibrinogen concentrate, a dry powder that can be quickly reconstituted and given at the bedside, with cryoprecipitate, a blood product that requires thawing before use and is harder to supply, especially in remote areas. Participants will receive either 3 grams of fibrinogen concentrate or standard doses of cryoprecipitate (10 units whole blood or 4 units apheresis). This approach aims to evaluate the effectiveness, safety, and cost of these treatments in managing severe bleeding after trauma. Participants will be adults with trauma who are actively bleeding and require emergency blood transfusions. Researchers will monitor the number of days participants are alive and out of the hospital within 90 days after injury. The study will also assess safety and resource use. A total of 850 patients will be enrolled from major trauma centers in Australia and New Zealand, with follow-up to 90 days post-injury.