Sande

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

Researchers are evaluating the safety and functional outcomes of intravenous thrombolysis IVT in adult patients who have recently taken direct oral anticoagulants DOACs and experienced an acute ischemic stroke. This international, prospective observational registry aims to understand whether IVT can be safely administered to these patients and if it improves recovery. The study involves collecting data from about 2800 participants across multiple stroke centers and comparing three groups based on recent DOAC intake and IVT treatment status. Participants are divided into three groups those who have taken DOACs recently and receive IVT, those who have taken DOACs recently but do not receive IVT, and patients without recent DOAC intake who receive IVT. The study collects detailed information about the timing, dose, and type of IVT drugs used Tenecteplase and Alteplase, as well as any complications that occur. The follow-up period lasts 90 days after the stroke event. During the study, researchers will monitor participants for symptomatic intracerebral hemorrhage within 36 hours after IVT and assess functional outcomes at 90 days using the modified Rankin Scale. Secondary evaluations include stroke severity, stroke volume, mortality, major bleeding, and other adverse events within specified timeframes. Data collection involves clinical assessments and imaging to understand stroke progression and treatment effects. Participants are observed for an average of two years for related study outcomes.

Researchers are conducting a registry study involving adult patients diagnosed with acute myeloid leukemia AML and related myeloid neoplasms, including newly diagnosed or relapsedrefractory cases. The study aims to collect comprehensive data on patient characteristics, family history, biological disease profiles, and clinical outcomes. It also focuses on analyzing disease-related genetic markers and the impact of measurable residual disease MRD using various methods. The study does not involve specific treatments but collects data and biological samples such as bone marrow, blood, plasma, and normal tissue including skin biopsies and other specimens. This observational study enrolls patients from around 80 to 90 sites in Germany and Austria. Patients treatment responses, decisions, and outcomes are tracked over time. Participants are observed for up to 10 years, during which researchers gather information on treatment response, survival, relapse rates, quality of life, and genetic markers. The study includes assessments of event-free survival, relapse-free survival, cumulative incidence of relapse and death, and overall survival. Patient consent is required for registration, data storage, and biobanking of specimens for analysis throughout the observation period.

Researchers are evaluating the safety and efficacy of intravenous thrombolysis IVT in adults who have experienced an acute ischemic stroke AIS and have taken direct oral anticoagulants DOAC within the last 48 hours. This international, multicenter, randomized trial compares IVT plus standard care to standard care alone in 906 participants to determine if IVT leads to better outcomes 90 days after treatment. Participants are randomly assigned to one of two groups one receives intravenous Tenecteplase or Alteplase along with the best medical treatment following local guidelines, while the other receives only the best medical treatment. The treatment is administered according to current recommendations from leading stroke organizations. The study aims to test whether IVT is superior in improving recovery in AIS patients with recent DOAC intake. During the study, participants are monitored and evaluated at multiple time points, including assessments of stroke severity, functional outcomes using the Modified Rankin Scale at 90 days, and quality of life questionnaires. Safety and efficacy are carefully tracked through these measures. Participants progress is followed up to about 90 days after randomization to assess the main outcomes and overall health status.