Nymburk 2

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating the occurrence of blood clot-related events in patients with congenital antithrombin deficiency who undergo surgery or childbirth. This study focuses on understanding the safety and effects of Atenativ, an antithrombin concentrate, in these patients. It is a Phase 3, open-label, uncontrolled trial conducted at multiple centers. Participants will receive Atenativ during surgical procedures or delivery. The study includes two patient groups: non-pregnant patients scheduled for elective surgeries with high clot risk, and pregnant patients at least 27 weeks along scheduled for cesarean section or delivery. In the United States, a small group of younger patients aged 12 to under 17 will first join a pharmacokinetic phase before receiving treatment if appropriate. Throughout the study, participants will be monitored for up to 30 days after treatment begins to track the incidence of thrombotic and thromboembolic events. Researchers will assess safety, pharmacokinetics, and treatment effects. Participants provide informed consent and undergo urine pregnancy testing when applicable. The study aims to gather comprehensive data on Atenativ's performance in this specific population.