Penrith

Researchers are investigating the safety and effectiveness of efruxifermin in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study is randomized, double-blind, and placebo-controlled, enrolling a total of 1650 participants in two groups to evaluate treatment outcomes. Participants will receive either efruxifermin or a placebo by subcutaneous injection. The study involves two cohorts, with Cohort 1 including patients who have biopsy-confirmed NASH or MASH and specific liver fibrosis and activity scores. The treatment period and detailed dosing schedules are not provided but the study compares the effects of the active drug against placebo. During the study, participants will be monitored for improvement in liver disease status, including resolution of NASH/MASH and at least a one-stage improvement in liver fibrosis after 52 weeks for Cohort 1. Long-term outcomes such as event-free survival will be observed over 240 weeks. Safety and efficacy assessments will be conducted throughout the study period, including evaluations of liver histology and metabolic health.

Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Researchers are evaluating the benefit of adding adjuvant durvalumab after neoadjuvant chemotherapy combined with durvalumab and surgery in patients with early-stage, operable non-small cell lung cancer (NSCLC), specifically stages IIB to IIIB (N2). This international, multicenter, open-label phase III trial aims to see if additional durvalumab treatment after surgery improves disease-free survival in patients who do not achieve complete pathological response after initial therapy. The study includes patients with resectable tumors who meet specific staging and health criteria.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are evaluating the use of fludrocortisone compared to placebo in patients who have experienced aneurysmal subarachnoid haemorrhage (aSAH), a severe type of stroke often affecting younger adults with significant risk of death and lasting neurological problems. This Phase 2, multi-centre, blinded, randomized clinical trial aims to find out if early treatment with enteral fludrocortisone can reduce death and dependency six months after the event. The condition has a high mortality rate and many survivors suffer cognitive impairments that affect quality of life and ability to work. Managing complications like hyponatraemia is challenging and costly, creating a need for effective, low-cost treatments. Participants will receive either fludrocortisone tablets, containing 100mcg, or matched placebo tablets. Treatment is initiated early after hospital admission for aSAH and continues while patients are cared for in a critical care environment. The study compares these two groups to assess if fludrocortisone can prevent hyponatraemia and improve neurological outcomes. Previous smaller studies suggested potential benefits but were not definitive, and this trial aims to provide clearer evidence with modern care standards. During the study, participants are monitored closely with blood tests to track sodium levels and other clinical assessments to evaluate neurological function and recovery. The primary outcome measured is the Modified Rankin Scale at six months post-randomization, which assesses disability and dependence. Safety is also monitored, and participants are followed through their hospital stay and after discharge to capture long-term outcomes and any adverse effects. The total participation duration spans at least six months for outcome measurement.

Researchers are evaluating the impact of scaling up finger-stick point-of-care testing for hepatitis C virus (HCV) to improve diagnosis and treatment rates. This observational cohort study focuses on people at risk of HCV infection, including those attending services like drug treatment clinics, needle and syringe programs, prisons, mental health services, and homelessness support. The study aims to address declining treatment uptake and challenges caused by COVID-19, contributing to national efforts to eliminate HCV by 2030. Participants will be offered finger-stick point-of-care testing for HCV antibodies, with results available within 1 to 20 minutes. If the antibody test is positive, a point-of-care HCV RNA test will be done to detect active infection. Those previously infected or treated will directly receive the HCV RNA test. No treatment is provided within the study, but participants with active infection will be connected to standard care services for clinical assessment and treatment initiation. Participants attend a single visit for testing and to complete a self-administered survey. The study will monitor the proportion of participants who start HCV treatment within 12 weeks after testing positive for HCV RNA. Researchers will also link survey data to health records to assess long-term impacts of expanded HCV testing and treatment. This approach aims to improve diagnosis rates and support efforts to reduce HCV-related health burdens.