San Bernardo

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.

Researchers are evaluating the effect of abelacimab compared to a placebo in patients with atrial fibrillation (AF) who are considered unsuitable for oral anticoagulation therapy. This study focuses on people at high risk for ischemic stroke or systemic embolism and aims to assess the safety and effectiveness of abelacimab in preventing these events. The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial involving patients with AF who have specific risk factors and treatment challenges. Participants will receive either abelacimab, provided as a liquid in vials at 150 mg/mL, or a matching placebo liquid. The study design includes parallel groups with blinded treatment assignment. The trial does not describe additional treatment phases or extensions but focuses on the comparison of abelacimab and placebo over the study duration. During the study, participants will be monitored for up to 30 months to measure the time until the first occurrence of ischemic stroke or systemic embolism, as well as the time until the first occurrence of serious bleeding as defined by the Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding. Safety and efficacy will be closely evaluated, with ongoing assessments to track these outcomes throughout the follow-up period.

Researchers are evaluating whether providing tuberculosis preventive treatment (TPT) during the "window period" can reduce new tuberculosis infections in children and adolescents who live with someone recently diagnosed with pulmonary tuberculosis. This cluster-randomized controlled trial focuses on preventing new infections by comparing immediate TPT to standard care, which only offers treatment to those already testing positive for infection. The study targets children and adolescents aged 5 to under 18 years who are household contacts of tuberculosis patients. Participants will be assigned to one of two groups. One group receives weekly doses of isoniazid and rifapentine for 12 weeks regardless of infection status at the start, while the other group receives the same treatment only if they test positive for infection at baseline. The treatment involves a 12-week course of the 3HP regimen, taken weekly. Those in the control group who test negative initially but convert to positive during follow-up also receive treatment after the 12-week period. Throughout the study, participants will undergo testing with the Interferon-Gamma Release Assay (IGRA) at enrollment and again after 12 weeks to detect new tuberculosis infections. Researchers will track the number of new infections by measuring IGRA conversions over this period. The study includes monitoring for treatment adherence and safety, with follow-up lasting at least 12 weeks. The results aim to inform better prevention strategies for tuberculosis in children and adolescents exposed in household settings.