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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the safety and tolerability of single and multiple intravenous doses of GIGA-2339 in adults with chronic Hepatitis B Virus HBV infection. This Phase 1 randomized, double-blind, placebo-controlled study aims to understand how the drug behaves in the body and monitor any treatment-related side effects in participants who have been living with HBV for at least six months. Participants will receive either a single intravenous infusion of GIGA-2339 or a placebo in increasing doses on the first day. Following this, participants will receive multiple intravenous infusions of the drug or placebo once every four weeks at the dose determined during the single-dose phase. The study includes two parts Part 1 for single ascending doses and Part 2 for multiple ascending doses, both designed to assess safety, tolerability, and how the drug is processed in the body over time. During the study, participants will undergo regular evaluations including blood tests to measure drug concentration and monitor liver function, safety assessments for any adverse events, and other laboratory tests over periods up to 105 days for single doses and up to 245 days for multiple doses. Researchers will track treatment-emergent adverse events, serious adverse events, and detailed pharmacokinetic data to understand the drugs behavior. Participation may last several months, with visits scheduled according to dosing and monitoring needs.

Age: 18Years +All GendersPhase 1
19 locations
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Actively Recruiting

Researchers are studying finerenone to evaluate its safety and effectiveness in patients hospitalized with acute decompensated heart failure who have mildly reduced or preserved left ventricular ejection fraction. This international trial is randomized, double-blind, and placebo-controlled, focusing on how finerenone compares to placebo in reducing heart failure events and cardiovascular death. Participants receive either oral finerenone or a matching placebo while hospitalized or recently discharged for heart failure. The study monitors patients over approximately 30 months to assess the total heart failure events, cardiovascular death, and adverse events related to the treatment. Throughout the study, participants undergo regular assessments including symptom scoring using the Kansas City Cardiomyopathy Questionnaire, monitoring for serious adverse events, and evaluation of heart failure outcomes. The study tracks safety and efficacy data over the long term, with follow-up visits scheduled to measure the impact of treatment on morbidity and mortality in heart failure patients.

Age: 18Years +All GendersPhase 3
315 locations