ANZCTR search results

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS TMPRSS6-Lrx Administered Subcutaneously for up to 44 Healthy Volunteers

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/µL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

This Phase 3/4, randomized, observer-blind, multi-center study, stratified study evaluated the immune (antibody) response, efficacy and safety of a cell-derived quadrivalent subunit influenza virus vaccine (Seqirus QIVc) in comparison with a non-influenza comparator, meningococcal serogroup A, C, W-135, and Y (Menveo®, GlaxoSmithKline Biologicals, S.A.) in healthy pediatric subjects =2 Years to \<18 Years of Age

To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score as assessed by dual-energy X-ray absorptiometry (DXA) at 12 months in children 5 to 17 year of age with Glucocorticoid (GC)-induced osteoporosis (GiOP).

This is a partially double-blind study in healthy adult subjects, which will be conducted as a placebo- and active-controlled, single-dose, crossover study. Twenty-eight subjects will be enrolled to ensure 24 subjects on all study periods. All subjects will receive all 3 study treatments (GC4419, placebo and moxifloxacin) in randomized sequence. Cardiodynamic assessment using continuous ECG recordings (Holters) will be performed for approximately 26 hours on the day of dosing (Day 1) in each study period. ECGs will be extracted serially pre- and post-dose and predefined timepoints at which subjects will be supinely resting. Subjects will be supinely resting for at least 10 minutes prior to and 5 minutes after each nominal timepoint for ECG extraction. Blood draws for PK will be performed in all periods at the same timepoints and always after ECG extraction. Subjects will be domiciled in the clinic from noon/afternoon of the day before dosing (Day -1) until completion of safety procedures on Day 2 in each study period. All subjects (including subjects who terminate the study early) will return to the clinical research unit (CRU) 14 (± 1) days after the last administration of study treatment for follow-up procedures and to determine if any Adverse Event (AE) has occurred since the last study visit.

The aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. Outcome measures will include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

This Phase 1 clinical study is a double-blind, randomized, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics (PK), food effect, and drug interaction potential of ACHN-383 and ACHN-789 co-administered orally as separate capsules in healthy subjects

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for many years to help treat cancers such as prostate cancer and breast cancer, but it is not currently used in melanoma. We hope the addition of denosumab to current melanoma therapies will make these treatments work better without adding to the side effects. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with metastatic melanoma (melanoma that has spread). Study details: Nivolumab and ipilimumab are approved treatments for advanced melanoma in Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study, are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as standard care. However, there is limited information on the effectiveness and safety of these treatments in combination with denosumab. Recent melanoma research in animal models has shown that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because denosumab has been used in patients with breast and prostate cancer for a long time and is safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in this study.