ANZCTR search results

Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

The purpose of this study is to compare the effects on patients with metastatic melanoma of taking a government approved and paid-for PD-1 inhibitor intermittently, with taking the same type of agent continuously. Researchers want to see if the two ways of giving this type of treatment work equally well in extending the life of patients with melanoma, or not.

This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.

An interventional Phase 4 open-label, randomized, controlled, parallel-group, multi-country study in participants with psoriatic arthritis (PsA) consisting of 2 parts: Part 1 (Day 1 up to Week 16) is designed to compare the achievement of minimal disease activity (MDA) between participants randomized to either adalimumab in combination with methotrexate (MTX) or MTX alone escalated to the highest recommended or tolerable dose; Part 2 (Week 16 through Week 32) is designed to evaluate the maintenance or achievement of MDA on 4 different treatment regimens using adalimumab and/or MTX, with participant allocation based on the initial randomized treatment and achievement of MDA in Part 1, and with rescue treatment option.

Acute pancreatitis (AP) in children has an increasing incidence and is at times associated with significant morbidity and mortality. Despite this, there is no high-quality evidence-based treatment for childhood AP and current practice is based entirely on historical approach and extrapolation from adult studies. In this study, we evaluate the use of early enteral feeding in children with AP. The traditional approach to treating AP relies on fasting and intravenous fluids (or occasionally parenteral nutrition) assuming that this minimizes stimulation of an already inflamed pancreas. Contrary to this, evidence exists that early feeding of patients with AP may be beneficial. Randomized controlled trials of fasting vs. early oral diet in adult patients with mild AP, showed no differences in pain, serum amylase and CRP levels, but also shorter hospital stay in those fed earlier. Further data in adults with severe AP demonstrated that early enteral nutrition was associated with decreased mortality, infections and multiorgan failure. These benefits were lost if enteral nutrition was commenced 48 hour after admission. Suggested explanations for these findings include the possibility that enteral nutrition may maintain integrity and function of intestinal mucosa and reduce gut-origin sepsis. Historically, nasojejunal (NJ) feeds were felt to be safer than oral or nasogastric feeds in the setting of AP by avoiding cephalic and gastric pancreatic stimulation. NJ feeds require moderately invasive tube insertion under radiographic or endoscopic guidance. Recent data suggest that oral feeding with a low fat diet was as safe as NJ feeding. Several animal models of AP demonstrate that the exocrine pancreas is resistant to cholecystokinin (CCK) stimulation after the onset of AP, suggesting a mechanism for the lack of concern of exacerbating pancreatitis with enteral feeds. Considering this data it is less certain that diet and fat restriction contribute to treatment of AP. To further challenge the prior conceptions of AP management it is necessary to explore the use of unrestricted diet (full fat) in mild-moderate pediatric AP, a population with recognized low complication risk. Despite the mounting evidence to the contrary, it is still standard clinical practice to fast children with AP, and only slowly reintroduce feeds depending on the clinical improvement. This is largely due to the lack of clinical interventional studies in children with AP.

Objective: To evaluate the potential impact of molecular phenotyping of transbronchial biopsies in lung transplant recipients with allograft dysfunction, and the potential for developing a safer endobronchial mucosal biopsy format.

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review \[IIR\] using Response Evaluation Criteria in Solid Tumors \[RECIST 1.1\]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.