ANZCTR search results

Non-immune people exposed to hepatitis A are recommended to receive either hepatitis A vaccine or normal immunoglobulin (which contains hepatitis A antibodies), with the latter recommended for those in the most vulnerable groups. We have previously completed a pharmacokinetic modeling study using published data to estimate the minimum dose of hepatitis A antibodies that would be protective against hepatitis A up to day 50 after injection. This modeling study supported the hypothesis that the current national guideline provides insufficient antibodies for people who weigh over 85kg. The current study seeks to validate these modelling results in order to recommend the optimal dose of normal immunoglobulin for the prevention of hepatitis A. This study will compare the level of antibodies present in blood as a result of passive immunisation with the recommended dose of normal immunoglobulin to the level of antibodies in blood as a result of dosing by weight with the same product in healthy adults. To do this, we will conduct a randomised controlled trial where the usual care group will receive 2mL normal immunoglobulin irrespective of weight, and the test dose group will received 0.025mL/kg to a maximum of 5mL of normal immunoglobulin. Blood samples will be taken from both groups at days 0, 1, 3, 7, 28 and 50 and the groups mean hepatitis A antibody titres compared.

The aim of this study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for stage III colon cancer. Study details All participants in this study will have a blood draw during week 5-6 post surgery for ctDNA analysis. They will then be randomly allocated to one of two treatment groups. One group will receive standard of care treatment as selected by their clinician: either no chemotherapy, single agent fluoropyrimidine chemotherapy or combination fluoropyrimidine plus oxaliplatin chemotherapy. Treatment selection in the other group will be informed by ctDNA blood test results. All patients will be followed up every 3 months for 2 years, then every 6 months for 3 years in order to evaluate treatment safety and efficacy. Follow-up involves additional blood tests and radiological assessments. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision regarding adjuvant chemotherapy is not inferior to standard of care in terms of recurrence-free survival.

The primary purpose of the study is to determine the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PXS-5382A after oral administration SAD This is a randomised, double-blind, placebo controlled, dose escalating study with single ascending dose of PXS-5382A. There will be 6 cohorts consisting of 8 subjects each. Subjects within a cohort will be randomly assigned to one of the two groups (PXS-5382A or placebo) in a 3:1 ratio respectively. Sentinel dosing will be conducted for each cohort, such that; Sentinel dosing – Total N = 2, where N=1 = PXS-5382A N=1 = Placebo Main Cohort – Total N = 6, where N=5 = PXS-5382A N=1 = Placebo Doses will be escalated across the cohorts but not within each cohort. The starting dose and incremental dose increase through the cohorts has been determined based on the results of the pre-clinical studies. MAD Multiple ascending doses of PXS-5382A will be assessed during the MAD phase of the study. Within each cohort, each subject will be randomly assigned to one of the two groups (PXS-5382A or placebo) in a 3:1 ratio respectively wherein each subject will receive the active drug or placebo once daily. The doses and dosing duration chosen for MAD will be based on evaluation of the PK data and all safety information as well as any other relevant data that is available from the SAD phase

Obesity has reached epidemic proportions globally and is associated with serious co-morbidities, including type 2 diabetes. Once adipose tissue has been accumulated, and food intake is limited by low calorie diets, counter-regulatory mechanisms induce an increase in appetite and a decrease in energy expenditure, which makes weight loss very difficult to maintain. To combat the global burden of obesity and its co-morbidities, a major challenge lies in the development of effective therapies that increase fullness and satiety, and result in improvements in blood glucose control, while lacking adverse effects that are often associated with current therapies. There is increasing evidence that nutrient stimuli in the gastrointestinal tract play a central role in the control of energy intake and blood glucose. Proteins, and their building blocks, amino acids, are of interest, as high-protein diets are very effective for weight loss, particularly loss of fat, rather than muscle mass, and for improving postprandial glycaemic control, in obese individuals with and without type 2 diabetes. There is some evidence that a number of amino acids (including L-tryptophan) also have effects on energy intake, blood glucose and gut function in humans. We have previously investigated the effects of intraduodenal tryptophan and found that its effects to reduce subsequent energy intake were related to plasma cholecystokinin and tryptophan concentrations prior to the test meal. Thus, amino acids, here specifically tryptophan, may represent potential therapeutic approaches for obesity and type 2 diabetes. We have recently evaluated the effects of intragastric tryptophan at 3 g on gastric emptying, blood glucose, gut hormones, and appetite following a mixed-nutrient drink. Energy intake at a subsequent buffet style meal was also assessed. L-tryptophan slowed gastric emptying in both lean and obese groups. While overall energy intake was not affected, there was a decrease in energy intake in approximately half the subjects of each group, but less so in the obese. In the lean group, energy intake was found to be related to elevated concentrations of plasma tryptophan. A limitation of this study design may have been too long a duration between tryptophan administration and the meal at which energy intake was assessed (1 hr 15 min), thus mitigating the overall effect on energy intake. This new study has been designed with a shorter duration between tryptophan administration and buffet meal (30 min) and will investigate the effects of intragastric administration of L-tryptophan, vs saline control, on energy intake at a subsequent ad libitum buffet style meal, and the relationship with plasma gut hormone and tryptophan concentrations, appetite perceptions and intragastric volume in healthy, normal weight and obese, subjects.

Many patients with Chronic Obstructive Pulmonary Disease (COPD) also have elevated lung blood pressures, or pulmonary hypertension (PH). Having both conditions increases the risk of death. It is difficult to diagnose PH in COPD. We will be using a new Computed Tomography (X-ray imaging) technique to investigate a marker of PH called ‘pulmonary artery pulsatility’. If PH can be diagnosed easily and accurately new treatments can be devised and researched potentially improving outcomes in COPD.

The purpose of this study is to establish the safety and tolerability of orally administered CNSA-001 in healthy subjects follow single and multiple-dose escalation This Phase 1 study will support dose selection for future studies in patients with Segawa Syndrome

The primary purpose of this study is to show that by using ctDNA results, in addition to assessing the risk of tumour recurrence by standard pathology assessments, the number of patients receiving adjuvant (post surgery) chemotherapy will be reduced. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have received chemo-radiation followed by surgery for locally advanced rectal cancer. Study details: All patients enrolled in this study are randomly allocated (by chance) to one of two groups; Standard of care (SOC) group or the ctDNA-informed group. The decision to proceed with chemotherapy for those in the SOC group is based only on the standard risk assessment of the tumour (how likely your tumour is to come back or recur). Their ctDNA result will not be disclosed. Those who are randomised to the ctDNA-informed group will be treated with chemotherapy if they are ctDNA positive OR if they are ctDNA negative AND are considered to have a tumour at high risk of recurring based on the standard risk assessment. Only those in the ctDNA-informed group who have chemotherapy will have monthly ctDNA samples collected; up to four samples collected over 4 months then a final sample after chemotherapy has finished. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision as to who receives adjuvant chemotherapy will result in a reduction in the number of patients having chemotherapy and doing so, without compromising the rate of disease recurrence when compared to standard of care.

Despite pain being the primary reason most patients present to emergency departments (EDs), current methods of pain management in EDs are suboptimal. Patient controlled analgesia (PCA) involves the patient self-administering intravenous analgesia via a pre-set medication administration pump. Although PCAs have being rigorously evaluated and widely used in other clinical areas, they are not routinely used in EDs. This study will determine if PCAs are a feasible mode of analgesic delivery in the ED environment. A feasibility pilot randomised controlled trial (RCT) will be conducted in one private hospital ED to determine the feasibility of using PCAs in EDs. This research will add to a limited body of knowledge in the area of pain management in EDs and potentially enhance pain management in the ED through the use of PCAs. As this is a feasibility pilot RCT, we hypothesise that PCA will be a feasible mode of analgesic delivery in EDs, However a larger-scale, multi-site RCT will be needed to further investigate this topic. .

Scalp dysesthesia is characterised by abnormal cutaneous sensations such as burning, stinging or itching of the scalp in the absence of objective dermatological findings. Scalp dysesthesia has been associated with cervical spine dysfunction, however there is no unified pathogenesis or agreed upon effective treatment. We hypothesise that the unpleasant sensations of scalp dysesthesia are the result of a sensory neuropathy secondary to cervical spine dysfunction. The aim of this pilot study is to evaluate the use of an exercise protocol consisting of cervical spine range of movement exercises, gentle mobilisation and muscle stretches over 4 weeks.

The purpose of this study is to characterize the safety and tolerability of single ascending doses of CSL346 following intravenous (IV) administration in healthy subjects. This is a 3-part first-in-human (FIH) study. Part A is a randomized, double-blind, placebo-controlled, single ascending intravenous (IV) dose protocol to be implemented in healthy Caucasian subjects. Part B is a single ascending IV dose escalation protocol which will test selected doses from Part A in healthy Japanese subjects. Part C is a single ascending dose escalation protocol which will test the subcutaneous (SC) administration of selected doses in Caucasian, and, if needed, Japanese subjects.