This multicenter, 2-part study included a Phase 1, open-label, selinexor dose escalation and expansion part (enrollment completed), and a Phase 3, randomized, double-blind, placebo controlled part to evaluate the efficacy and safety of selinexor + ruxolitinib in treatment naïve patients with MF. Phase 1 was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation (Phase 1a) and a dose expansion part (Phase 1b). Phase 3 is ...

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The overall aim is: Part 1: To determine the efficacy of Pola-Glofit as bridging treatment to CAR-T cell therapy in patients with relapsed or refractory large B cell lymphomas. Part 2: To determine the efficacy of Pola-Glofit in patients with relapsed or refractory large B cell lymphomas who have failed to achieve complete metabolic response,or progressed after CAR-T cell therapy. The primary endpoints are: Part 1: Overall response rate (ORR) (Complete Metabolic Response (CMR) and Partial Metabolic Response (PMR)) after Pola-Glofit but prior to ...

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Study type Multicentre,non-blinded,feasibility randomised controlled trial Aim Feasibility study to assess feasibility of progressing to a full scale trial to evaluate strategies for platelet transfusion in participants with thrombocytopaenia and cancer associated thrombus (CAT) receiving anticoagulation Primary objective To determine the feasibility of designing and recruiting to a full RCT of management in participants with acute cancer-associated thrombosis (developed within 14 days) and thrombocytopaenia. Secondary objectives To determine: • Additional feasibility measures,such as recruitment rate,reasons for non participation in eligible participants and withdrawal rates and participation barriers ...

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This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of pegozafermin for the treatment of Stage 2 or 3 liver fibrosis in adult subjects with NASH (Noncirrhotic Nonalcoholic Steatohepatitis). The study is designed to assess the efficacy and safety of 2 dose regimens of pegozafermin, administered either weekly (QW) or once every 2 weeks (Q2W) in subjects with biopsy-confirmed NASH (NAFLD activity score [NAS] ≥ 4, fibrosis stage F2 or F3 [NASH CRN system]). Approximately 840 subjects will be randomized 1:1:1 ...

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This is a multi-national, randomized, double-blinded study to evaluate the safety and effectiveness of AVIM therapy in patients with uncontrolled hypertension with a previously implanted Medtronic Astra/Azure pacemaker. Over 500 participants will be recruited across 100 sites in UK, Europe and US. AVIM is an investigational therapy that can be added to a pacemaker to allow for specific settings that may help with the treatment of hypertension. The study will be performed in three phases, Screening/Run-In, Randomised double-blind and Randomised ...

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Terumo Aortic is a global medical device company dedicated to developing solutions for aortic and peripheral vascular disease. The purpose of this study is to gather further information on the use of the Thoraflex Hybrid device alone and in combination with the RelayPro NBS Stent-graft; to treat aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Both devices received CE certification, demonstrating conformity to applicable EU requirements. The Thoraflex Hybrid is ...

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Living with chronic pain can be tough for any young person. But while some young people may experience distressing thoughts, others may not. No young person should face these problems alone. So, it’s important for us to figure out who might be more vulnerable to distress, when, and why. That way, we can be there for them when they need it most. In total, 70 young people with chronic pain (aged 12-19 years) will be invited to take part. Over a ...

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This is a prospective, observational, non-interventional, multi-center, global clinical study of subjects with early to advanced stage STGD1 caused by bi-allelic likely pathogenic or pathogenic variants in the ABCA4 gene, confirmed genotypically by an accredited genotyping laboratory. The study will consist of 6 visits over a 96-week study period: Visit 1 (Screening Visit), Visit 2 (Week 16), Visit 3 (Week 32) Visit 4 (Week 48), Visit 5 (Week 72), and Visit 6 (Week 96). Subjects who discontinue the study early will ...

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Atrial Fibrillation (AF) is the most common cardiac arrhythmia and carries an increased risk of stroke. Stroke risk is commonly assessed using the CHA2DS2-VASC scoring system. To reduce stroke risk, guidelines advise AF patients with higher CHA2DS2-VASC scores be treated with oral anticoagulation (OAC), also known as blood thinning medication. OAC reduces the stroke risk, however it also increases the risk of bleeding episodes, which can be major and life-threatening. AF patterns can vary between patients. One patient may have only one ...

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Broken ankles in children often involve the area from which the bone grows – the growth plate. Following growth plate injuries, the growth of the main shin bone in the lower leg (the tibia) can be altered permanently, which can cause the bone to not grow at all, or to grow wonky. The younger the child at the time of injury (i.e. the more they have to grow) the worse the problem may get once the child has fully grown. ...

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