Murnau Am Staffelsee

Researchers are evaluating the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment for reversing anticoagulation in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. This Phase 3 trial aims to assess the safety and effectiveness of TAK-330 in managing direct oral Factor Xa inhibitor-related coagulopathy in this urgent setting. Participants will be randomly assigned to receive either TAK-330 or the standard care 4F-PCC before their surgery. TAK-330 is given as a single intravenous infusion of 25 IU/kg on Day 1, with a possible additional dose if needed. The standard 4F-PCC dosing and infusion speed follow local protocols, with an option for an extra dose not exceeding 50 IU/kg or 5,000 IU during surgery if required. During the study, participants will be hospitalized for surgery and monitored closely. Researchers will assess the effectiveness of stopping bleeding during surgery and follow up with participants by telehealth or phone call 30 days after surgery. The study will track safety and hemostasis to understand the impact of the treatments on bleeding control and patient outcomes.

This clinical trial investigates NG004, a human monoclonal antibody, in patients with acute incomplete cervical spinal cord injury (SCI). The study aims to assess the safety, tolerability, and pharmacokinetics of four different dose regimens of NG004. It is a first-in-human, multicenter, open-label, sequential, multiple ascending dose Phase 1 trial designed to find the maximum tolerated dose of NG004 in this patient group. Participants will receive repeated intrathecal injections of NG004, meaning the drug is administered directly into the spinal canal. The study evaluates four escalating dose levels to understand how the body processes the drug and to monitor for any side effects or adverse reactions. There is no placebo or comparator group; all participants receive the investigational treatment. Throughout the treatment period and up to six months afterward, participants will be closely monitored for any adverse events, including their type, frequency, severity, and relationship to the drug. The study includes regular clinical assessments to ensure patient stability and safety. Total participation duration includes treatment and follow-up for safety evaluation.