San Bernardo

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.

This trial investigates whether tuberculosis preventive treatment TPT given during the window period after exposure can reduce new tuberculosis infections in children and adolescents who live with someone newly diagnosed with pulmonary tuberculosis. The study compares the rate of new infections, measured by IGRA Interferon-Gamma Release Assay conversion at 12 weeks, between those who receive immediate preventive treatment and those who receive standard care where treatment is only given if infection is detected. The goal is to better prevent tuberculosis infection and contribute to global elimination efforts. Participants are assigned to one of two groups. In the intervention group, all children and adolescents receive weekly doses of isoniazid and rifapentine for 12 weeks regardless of their initial IGRA test results. In the control group, only those who test positive on the IGRA test at the start receive this 12-week treatment. Those in the control group who convert to IGRA-positive during the study will also receive treatment following standard care guidelines. During the study, all participants will have IGRA testing at enrollment and again after 12 weeks to detect new infections. Researchers will monitor treatment effects and adverse events related to the 3HP regimen, as well as measure changes in immune response levels. The study lasts 12 weeks with close follow-up to assess the incidence of tuberculosis infection and the safety of the preventive treatment in this young population.