Nymburk 2

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 with moderate to severe chronic obstructive pulmonary disease COPD who have type 2 inflammation and uncontrolled symptoms despite standard care. The study aims to assess the safety and effectiveness of depemokimab compared to a placebo when added to the usual treatment. This phase 3 trial is sponsored by GlaxoSmithKline and focuses on reducing COPD exacerbations and improving respiratory symptoms over a long period. Participants will receive either depemokimab by subcutaneous injection alongside their standard inhaler therapy or a placebo injection plus standard care. The study is randomized, double-blind, and includes two groups one receiving depemokimab and the other a placebo, both continuing optimized inhaler treatments. This study will last up to 104 weeks, with regular assessments throughout. During the study, participants will undergo evaluations including lung function tests, symptom questionnaires such as the COPD assessment test and St. Georges Respiratory Questionnaire, and monitoring for COPD flare-ups or hospital visits. Researchers will track the number and severity of exacerbations and changes in quality of life measures. Safety and tolerability will also be closely monitored throughout the trial duration, which extends up to two years.

Researchers are evaluating the incidence of thrombotic events and thromboembolic events in patients with congenital antithrombin deficiency who receive Atenativ during surgery or childbirth. This phase 3, open-label study aims to assess the safety, efficacy, and pharmacokinetics of Atenativ in these patients. The study includes both surgical patients and pregnant patients undergoing delivery, addressing an important need in managing this rare blood disorder during high-risk procedures. Participants receive Atenativ, an antithrombin concentrate, in two phases. In the pharmacokinetics PK phase, a single intravenous dose of 60 IUkg is given to analyze how the drug behaves in the body. In the treatment phase, patients receive an initial intravenous loading dose followed by maintenance doses every 24 hours for about 2 to 7 days if undergoing surgery, or about 5 days if giving birth by caesarean section or delivery. Throughout the study, participants undergo regular blood tests to monitor coagulation parameters and drug levels up to 14 days after infusion, as well as safety monitoring for adverse events up to 30 days after treatment starts. Researchers closely track thrombotic event incidence up to 30 days post-treatment. Participants are involved in scheduled visits for drug administration, blood sampling, and clinical assessments to ensure thorough evaluation of Atenativs effects and safety during and after treatment.