ANZCTR search results

WVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.

A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.

Despite a range of evidence-based programs to identify high-risk patients and apply strategies to keep them out of hospital, a growing number of cases are "resistant" to such programs. These "seasonal frequent flyers" routinely overwhelm hospital services. The investigators have identified vulnerability to provocation of seasonal and acute weather changes ("seasonality") as a major driver of preventable/costly hospitalisations in typically older patients with heart disease and multimorbidity subject to gold-standard care. From this research the investigators developed the RESILIENCE Program which is tailored to each person and designed to assist the participants to become more "resilient" to changes in the weather. The overall aim of the RESILIENCE Trial is to demonstrate the cost-effectiveness of an individually tailored, interventional health care program designed to address the debilitating, costly and deadly phenomenon of seasonal vulnerability in a growing number of individuals admitted to hospital with chronic heart disease and multimorbidity.

This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.

This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.

The purpose of this study is to determine and compare the effectiveness of WalkingTall-PD (the new intervention) against Mobility-plus (a PD appropriate exercise program) with respect to stabilizing gait, reducing step-time variability, preventing falls and enhancing independence in people with Parkinson's disease. WalkingTall-PD is a novel neuro-rehabilitation program delivered through a tablet/smart phone and smart socks for people with Parkinson's disease that aims to improve mobility and reduce falls. WalkingTall-PD combines a variety of PD-specific rhythmic stimuli (auditory, visual and haptic cues) which are synchronised with high intensity stepping, walking and balance training. Mobility-plus is a "pseudo placebo" comparator program using non-slip socks, a low intensity paper-based exercise program and health information specific to Parkinson's Disease.

The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).