ANZCTR search results

This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of a single administration of AXN-001 at increasing dose levels in the range of 1 mg to 16 mg. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence. Dose administration will be performed by the subcutaneous (SC) route for Cohorts 1 to 5. To enable determination of the bioavailability of the investigational product following SC administration, dose administration for Cohort 6 may be performed by the intravenous (IV) route. Cohort 7 may proceed via subcutaneous injection upon completion of cohort 5. The decision by the Safety Review Committee (SRC) to escalate between dose levels will be based on review of all available safety and PK data from previous cohorts. Up to 56 healthy male and female volunteers aged 18 to 55 years of age (inclusive) and with a body mass index between 18.0 kg/m2 and 32.0 kg/m2 are planned to be enrolled. Healthy volunteers will be screened between Day -28 and Day -2, inclusive. Participants will be admitted to the clinical facility on Day -1 with dosing to occur on the following day (Day 1). All participants will be dosed under fasted conditions. Seeking to address unmet medical needs for the acute treatment of migraine, Axon Therapeutics is developing AXN-001, a peptide CGRP-R antagonist as a subcutaneous (SC) formulation for the acute self-administered treatment of migraine.

Finding people with chronic liver disease and silent liver cirrhosis (scarring) who are at risk of liver failure and liver cancer is a critical public health issue. The AST-to-platelet ratio index (APRI) determines the risk of liver cirrhosis and is calculated using routine blood tests. In this study, we determine whether an innovative cirrhosis screening program of automated APRI calculation and provision of liver disease education information including a weblink for Fibroscan referral on routine pathology blood test results increases liver cirrhosis diagnosis and linkage to specialist care. We hypothesise that the inclusion of automated fibrosis scores will lead to an increased recognition of individual's at risk of significant fibrosis and improved linkage to care.

Brief summary: The purpose of this pilot study is to assess Skin Tear healing trends with the use of two differing wound dressing types (adhesive silicone foam dressing versus meshed silicone interface dressing), the dressing performance outcomes and the patient and staff satisfaction with the use of these two products. These two products are currently in use for the treatment of Skin Tears within the TPCH based on a standardised treatment regime. This regime is based on best available evidence, which included expert opinion and a regime generated by a dressing product manufacturer. Although the two options are based on a review of the evidence, there is minimal evidence in regards to their skin tear treatment efficacy. In practice, the decision to use one or the other is based on individual staff preference. The hypothesis is that one of the dressings advantages versus disadvantages, in comparison to the alternative will result in improved healing outcomes, patient and staff satisfaction. The design of the study is a randomised study of TPCH patients sustaining upper limb skin tears. A consecutive, convenience sample of 126 adults (aged 18 or over) will be recruited. Following consent patients will be randomised into two treatment arms with their Skin Tears dressed either with the adhesive silicone foam dressing or the meshed silicone interface dressing. Baseline data will be collected when the skin tear is first assessed and dressed, with follow up data will be collected at 7 days, 14 days, and 21 days.

This study will explore how diet and lifestyle, as well as age and gender (and other non-modifiable risk factors), are involved in the development of bowel cancer and pre-cancerous lesions (adenomas) in people considered at above average risk for bowel cancer due to either family history of bowel cancer or prior history of colorectal adenoma. Who is it for? Individuals are eligible to join this study if they are aged 18 years or older, and are currently enrolled in the Southern Cooperative Program for the prevention of colorectal cancer (SCOOP) Program for a surveillance colonoscopy. Study details: All individuals enrolled in the SCOOP program will be invited to complete and return an online or paper survey at years 1, 2 and 3, which will ask questions on diet, exercise, sleep and other lifestyle factors. The results from each survey and the changes in lifestyle over the 3 years will be compared to the findings at the regular surveillance colonoscopies, in particular the presence of advanced colorectal neoplasia (adenoma or cancer). It is hoped that the results of the study will improve the understanding of the interactions between diet and lifestyle behaviour, with the non-modifiable risk factors on the development of advanced neoplasia. It is hoped that this will be useful for identifying high-risk individuals who may benefit from targeted interventions to reduce their risk of developing bowel cancer and reducing the need for unnecessary colonoscopies for lower risk patients.

The 2-ASSURE trial will be a multi-centre Phase II rolling cohort study examining the optimal conditioning regimens of Autologous Stem Cell Transplant (AHSCT) for patients with severe systemic sclerosis. Patients will be stratified based on cardiac screening, age and co-morbidities. Those who have normal cardiac screening (as outlined in inclusion criteria), age less than 60 and no major co-morbidities will receive a standard dose of 200mg/kg cyclophosphamide in their conditioning in two separate cohorts. Those who have heart disease (as defined in inclusion criteria), age greater than or equal to 60 years or significant co-morbidities/poor performance status will receive a low dose regimen utilizing cyclophosphamide 140mg/kg +/- rituximab in two cohorts. This study aims to illustrate which low dose of cyclophosphamide is as effective in achieving remission compared to patients who received standard dose as part of their conditioning therapy for AHSCT.

This is a first in human study for MAP 315 designed to investigate the safety, tolerability and pharmacokinetics of multiple doses of MAP 315 in healthy adult volunteers. The pharmacodynamic effects of MAP315 will also be explored. The active ingredient of MAP 315 is a live bacterium that is a common member of the gut microbiome of healthy adults. MAP315 is being developed for the treatment of Ulcerative colitis. It is a randomised, double-blind and placebo-controlled study conducted at a single clinical trial centre with a satellite site as an alternate location for screening and outpatient assessments. The study will enroll 2 cohorts of 16 participants each, who will be randomised 3:1 to receive MAP 315 (4 x 10^7 CFU of MAP 315 per capsule) or its matching placebo for 14 consecutive days (2 weeks). The first Cohort will receive one capsule of MAP 315 (4 x 10^7 CFU of MAP 315 per capsule) or matching placebo daily administered orally for 14 consecutive days, (total daily dose of 4 x 10^7 CFU of MAP 315). Cohort 2 will receive four (4) MAP 315 capsules, twice daily for a total of 8 MAP 315 capsules per day for 14 consecutive days, (a total daily dose of 3.2 x 10^8 CFU of MAP 315). The capsules are administered orally with water and regardless of food. Participants in the study will be confined in the clinical research unit (CRU) from Day -1 until Day 3, when they will be discharged after completion of all CRU-based assessments scheduled for that day, in the absence of clinically significant signals, at the discretion of the Principal Investigator. Both dose level cohorts (Cohort 1 and Cohort 2) will include at least 2 sentinel participants: 1 to receive MAP 315 and 1 to receive placebo. If dosing of the sentinel participants proceeds without clinically significant safety signals up to at least 72 hours (h) following the administration of the initial study drug dose, as determined by the Principal Investigator in consultation with the local Medical Monitor and Sponsor if required), the remaining 14 participants in the cohort can be dosed according to the randomisation schedule. The decision to proceed to Cohort 2 of the study will be dependent upon review of data from all participants in Cohort 1 up to at least 6 days after the beginning of dosing (ie, the Day 7 visit) by a safety monitoring committee (SMC). This will include the review of all safety data and available PK data for at least 12 participants in Cohort 1.

Polymyalgia rheumatica (PMR) is a common condition that causes severe pain and stiffness at the shoulders and hips in patients over the age of 50 years. Up until now, its diagnosis has been based on the patient’s symptoms and high levels of inflammation detected in their blood. However, this approach is not always accurate. A special CT scan (whole body positron emission tomography/computed tomography [PET/CT]) capable of detecting areas of inflammation throughout the body has recently been recognised as a new test to help diagnose PMR. In research studies, it appears to be better than the current approach to diagnosis. The easiest way to analyse these scans is not yet known though. In 2020, a simplified way to diagnose PMR on whole body PET/CT was developed. In this study, this simplified method will be investigated to determine its accuracy in a group of patients with a suspected new diagnosis of PMR.

Pulmonary rehabilitation (PR) is effective in reducing exacerbations and hospital admissions, improving health-related quality of life, exercise tolerance, and symptoms of breathlessness and fatigue in people with chronic obstructive pulmonary disease (COPD) and other chronic lung diseases such as interstitial lung disease, Bronchiectasis. However, despite the robust evidence for the benefits of PR, uptake is low, with 8-50% of those referred to PR never attend and 10-32% of those who commence not completing the program. Studies from the United Kingdom report that low PR program uptake, high non-attendance and non-completion rate are particularly evident in people who have physical frailty or high levels of anxiety and/or depression. In the elderly population with chronic lung disease, frailty is characterised by multisystem decline encompassing physical, cognitive, social and psychological aspects. Frailty is prevalent in people with COPD when compared to healthy age-matched community living individuals as young as 50 years old and is strongly associated with a higher risk of mortality. One in five people who are frail and living with COPD suffer from adverse outcomes such as increased risk of acute exacerbations and hospitalisations. A recent systematic review reported that frailty is associated with respiratory impairment and poorer health-related quality of life in people with COPD, idiopathic pulmonary fibrosis (IPF) (a subcategory of ILD) and asthma. There are no studies in people with other chronic lung diseases, such as ILD other than IPF or bronchiectasis, who are commonly referred to PR. Thus, frailty is now highlighted as an important condition that needs to be recognised and managed to improve patient outcomes and reduce healthcare costs. However, in Australia, there are no data on the proportion of people with chronic respiratory diseases referred to PR who have physical frailty, anxiety and/or depression, and the relationship between physical frailty, anxiety and/or depression and the uptake, attendance and completion of PR in people with chronic lung disease is unknown. The hypothesis of the study is people who have chronic lung disease and is physically frail, anxious and/or depressed have poor uptake, attendance and completion of a PR program.

To determine if supervised home spirometry can replace in-lab spirometry when needed, this study will evaluate Australian Register of Therapeutic Goods (ARTG) approved home spirometry quantitative and qualitative performance compared with in-lab spirometry supervised by a respiratory scientist. Older spirometers (> 1 year of use) will have a calibration check to assess ongoing validity of results. Hypothesis: a) Supervised outpatient spirometry indices (FEV1, FVC) and grade performed on a personal portable spirometer via Telehealth and standard in-lab spirometry 15 minutes apart in patients with chronic lung disease will be comparable b) Home spirometers will remain reliable after > 1 year of use

This will be a blinded, placebo-controlled clinical trial conducted within natural medicine clinics. Initial screening and consenting of participants will be conducted by the Co-Investigator and participants allocated to individual naturopathic clinicians for assessment interviews. The study includes two active treatment options and a placebo control. Participants will be allocated into Treatment Arm #1 or Treatment Arm #2 based on their initial clinical presentation, categorised into either an ‘anxiety-driven’ stress type (Treatment Arm #1) or a ‘non-anxiety driven’ stress type (Treatment Arm #2). Participants will be tested for stress, depression and anxiety indices at baseline and at day 21 for changes in these areas.