This is a phase 1b vaccine efficacy study of ID93/GLA-SE in historically BCG-vaccinated and BCG-naive healthy adult volunteers using an aerosol BCG challenge model. There will be four study groups with twelve volunteers in each group (Table 2). Volunteers will be randomised to eligible groups based upon their BCG vaccine status,and will either be given 2 μg ID93 + 5 μg GLA-SE at Day 0 and Day 56 (Group A and C) prior to BCG aerosol challenge,or proceed directly to ...

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von Willebrand disease (vWD) is reported to be the most common bleeding disorder, with prevalence estimated at 1% of the general population. Despite this, little is known about its natural history, or of the impact it has on affected individuals. The Haemnet vWD.360 programme is a mixed-methods, natural history study designed to better understand vWD and its impact on individuals. It comprises both qualitative and quantitative approaches and is designed to include the perspectives of individuals with a diagnosis of ...

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Primary Aim: 1. To assess the bias,precision,limits of agreement and 30% accuracy of eGFR equations compared to measured GFR for people of different ethnicities (e.g. South Asian,Chinese,South-East Asian and Black) in the United Kingdom,compared to people of reported White ethnicity. Design: Retrospective observational data only multi-centre cohort study. Study Population: People with both normal kidney function and chronic kidney disease,who have had a measured GFR test and a paired eGFR test (within 30 days),between 2009 and 2022 inclusively. The study population will include ...

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This is a phase 1 study exploring differences between the immunological responses to revaccination with intradermal-BCG and aerosol-inhaled BCG in healthy adults and those with pre-existing T2DM. There will be three study groups with twelve volunteers in each group (Table 2). Volunteers will be enrolled into groups based upon whether they have a diagnosis of T2DM. They will then be vaccinated with intradermal BCG (Groups A and C) or aerosolised BCG (Group B). Objectives: Co-Primary: To compare the immunological response of BCG ...

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To assess the safety and tolerability of neoadjuvant ASTX727 (decitabine and cedazuridine) and Nivolumab combination therapy and determine the maximum tolerated dose combination (the dose associated with no more than 25% dose limiting toxicity (DLT) rate).

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In patients with heart failure, serum hypomagnesaemia is common and attributed to increased renal magnesium (Mg2+) secretion and diuretic therapy. Serum hypomagnesemia is associated with increased heart failure presentations and hospitalisations in patients with heart failure with preserved ejection fraction (HFpEF). There is a poor correlation between serum Mg2+ (the compartment which can be measured) and intracellular Mg2+ concentrations9 (the compartment in which Mg2+ regulates cellular processes) with serum Mg2+ being a poor surrogate for total body Mg2+ content. Using ...

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ARTEMIS is a phase II,multi-centre,open-label,randomised controlled trial using IMRT/VMAT/TomoTherapy,comparing radiotherapy (SCRT/LCCRT) followed by chemotherapy (FOLFOX/CAPOX),with or without the addition of AN0025 throughout treatment. Eligible patients will have moderate to high-risk rectal cancer where pre-operative chemoradiotherapy (CRT) or total neoadjuvant treatment (TNT) are standard treatment options and who are interested in organ preservation. ARTEMIS uses the Sargent’s three-outcome two-stage comparative design,including an interim analysis for futility. The trial will randomise 140 patients,from 15-20 UK radiotherapy sites,with a 1:1 allocation ratio to receive ...

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Cirrhosis (scarring of the liver) can lead to varices (abnormally enlarged veins) developing in the lower gullet (food pipe) or stomach causing the varices to bleed. Variceal bleeding is a serious complication of liver cirrhosis. The currently accepted treatment for patients who bleed from varices is known as standard of care (SOC) and includes using an endoscope (a bendy tube incorporating light and a tiny video camera) to tie off an enlarged vein with a rubber ring (variceal banding) or ...

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Transplant recipients will be invited to enrol in this LTFU study after they have completed the End-Of-Study (Week 84) visit or withdrawn from the Phase I/IIa study (TX200-KT02). Transplant recipients who were administered TX200-TR101 in the TX200-KT02 study will then proceed to have 13.5 years of follow-up post-enrolment to this study (equating approximately to 13.75 years of follow up post-end of ‘parent’ KT02 study). Since these subjects will have completed the first 1.5 years of follow-up post-dosing with TX200-TR101 in ...

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A prospective,randomised,phase II platform trial for sequential evaluation of experimental treatments versus investigator choice standard therapy (ICT) for patients with relapsed or refractory follicular lymphoma (rrFL). There are three sequential treatment rounds; each has a control arm of ICT and an experimental novel treatment arm. Patients in Round 1 (R1) will be randomised using a 1:1 allocation ratio to receive either ICT or epcoritamab + lenalidomide (experimental treatment). Patients in Rounds 2 (R2) and 3 (R3) (experimental treatments yet to ...

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