Ngo Quyen

Researchers are studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease (CKD) and high blood pressure (hypertension). This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are studying the effects of EYU688, an oral medication, compared with a placebo in patients with dengue fever. The study aims to understand how EYU688 affects dengue viral load, fever clearance time, and clinical signs and symptoms. This randomized, participant- and investigator-blinded, placebo-controlled trial includes two parallel groups with different pharmacokinetic sampling schedules. Participants will receive either EYU688 or a matching placebo capsule orally. The study consists of two cohorts running at the same time with intensive pharmacokinetic sampling in one and sparse sampling in the other. The research evaluates safety, efficacy, and pharmacokinetic properties of EYU688 over a treatment period. During the study, participants will undergo assessments including viral load measurement, fever monitoring, laboratory tests for blood counts and liver enzymes, and evaluation of dengue severity signs. Safety will be monitored through adverse event tracking up to 35 days. The primary outcome focuses on viral load reduction 48 hours after treatment starts, with secondary outcomes covering fever duration, clinical recovery, and other health indicators up to 15 days post-fever onset.

Researchers are evaluating the effectiveness and safety of QMF149, a combination of indacaterol acetate and mometasone furoate, compared to budesonide in children aged 6 to less than 12 years who have asthma. The study is a double-blind, randomized, active-controlled, two-period crossover trial designed to assess which treatment better improves lung function as measured by FEV1. This Phase 3 trial includes children with asthma who have a predicted FEV1 of 50% or more and aims to gather detailed safety and efficacy data over a structured timeline. The trial lasts up to 37 weeks and includes several distinct periods: a screening phase of up to 3 weeks, a 3-week run-in period with a specific inhaled corticosteroid (Fluticasone propionate 50 mcg twice daily), followed by two 12-week treatment periods where participants receive either QMF149 75/40 mcg once daily or budesonide 200 mcg once daily via Breezhaler. Between these treatment periods is a 3-week wash-out phase using the same run-in medication. After all treatment phases, there is a 4-week safety follow-up period where patients return to their standard care. Participants regularly visit the study center approximately every 3 to 6 weeks for assessments including lung function tests, asthma control questionnaires, and monitoring of adverse events. Parents or guardians assist with medication compliance and diary entries. The study measures changes in lung function, asthma symptoms, rescue medication use, and exacerbation rates. Safety is closely monitored throughout, including during the follow-up period. The total commitment for each participant covers the entire 37-week duration of the study.

Researchers are evaluating AZD0292, a bispecific IgG1k monoclonal antibody, for preventing exacerbations in patients aged 12 years and older with bronchiectasis who are chronically colonized with Pseudomonas Aeruginosa (PsA). This Phase IIb study focuses on patients with non-cystic fibrosis bronchiectasis (NCFBE) and a history of frequent pulmonary exacerbations due to chronic PsA colonization. It also includes an exploratory group of bronchiectasis patients with cystic fibrosis (CF) colonized with PsA to explore broader applicability. The study compares two doses of AZD0292 given by intravenous infusion starting on Day 1, followed by subsequent doses according to a schedule of assessments, against a placebo group receiving similar infusions. Participants are randomized into three groups: high-dose AZD0292, low-dose AZD0292, and placebo. Treatment continues throughout the study with multiple administrations as scheduled. Participants will be involved in regular monitoring including clinical assessments and laboratory tests to track lung function, quality of life, and safety outcomes. The primary outcome is the annualized rate of exacerbations over a follow-up period ranging from 28 to 52 weeks. Secondary measures include severe exacerbation rates, quality of life scores, time to first exacerbation, serum drug concentrations, immune response to the drug, and incidence of adverse events. Safety monitoring extends to 24 weeks after the final dose, with comprehensive evaluation throughout the study duration.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have a COPD diagnosis of at least one year, be receiving inhaled maintenance therapy, and have experienced at least two moderate or one severe COPD exacerbations in the past year. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to better understand tezepelumab's impact on COPD symptoms and exacerbations. Participants will be randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment phase will last for a minimum of 52 weeks and up to 76 weeks. After completing the treatment period, there will be a 12-week off-treatment safety follow-up to monitor participants' health. Throughout the study, participants will undergo regular assessments including lung function tests, questionnaires such as the St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT), and blood tests to measure eosinophil counts and drug levels. Researchers will track the annualized rate of moderate or severe COPD exacerbations as the primary outcome. Other evaluations include monitoring exacerbations requiring emergency visits or hospitalization, lung function changes, symptom scores, and immune responses. Participant safety and adherence to the study protocol will be closely monitored during and after treatment.

Researchers are studying adults who have had an acute ischemic stroke caused by a blood clot blocking a brain blood vessel. This study focuses on people whose stroke started more than 4.5 hours ago or who woke up with stroke symptoms, with imaging showing brain tissue that can still be saved. The goal is to evaluate whether the medicine tenecteplase given after 4.5 hours helps recovery compared to standard care. Participants are randomly assigned to one of two groups. One group receives a single injection of tenecteplase into a vein, while the other group gets the standard medical treatment. The study lasts about three months, starting with about one week of hospital stay. During this time, participants receive seven clinical evaluations, with the last two visits likely done remotely from home. Doctors assess recovery using a scale that measures disability and daily function levels to compare outcomes between groups. They also monitor health and any side effects. The main outcome is the level of disability at 90 days after treatment, measured by the modified Rankin Scale. This comprehensive monitoring helps understand how the treatments affect stroke recovery and safety over the study period.

Infants commonly experience functional gastrointestinal symptoms such as colic, excessive gas, regurgitation, constipation, or loose stools, which can distress families and may be linked to an imbalance in the gut microbiome. This research evaluates whether the multistrain probiotic BioAmicus Complete can improve these caregiver-reported symptoms in infants aged 0 to 24 months and assesses its safety in this group. The study also explores changes in stool microbiome composition and diversity over time. Participants are randomly assigned to one of two groups: one group receives BioAmicus Complete oral probiotic drops along with usual care for 42 days, while the other group receives standard clinical management without probiotic supplementation. Caregivers administer the probiotic drops per protocol, and use of other probiotic products is avoided during the study. Concomitant medications and routine care are allowed at the investigator's discretion. Adherence to the probiotic regimen is recorded. During the study, caregivers complete questionnaires and diaries to report gastrointestinal symptoms and quality of life. Researchers monitor growth parameters like weight and length, track health care use and antibiotic exposure, and collect stool samples for microbiome analysis. Safety is assessed by recording adverse events. The primary measure is the change in Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from baseline to day 42. Secondary measures include stool frequency and consistency, symptom domains, and overall safety outcomes. The study runs until May 2026.

Poor appetite is common in young children and can affect their nutrient intake and eating behavior. This research aims to evaluate whether a zinc-containing oral supplement called Biolizin syrup can improve eating behavior in children aged 6 to 36 months who have poor appetite without a clear medical cause. The study is randomized and controlled, focusing on changes in feeding difficulty and eating behavior over 42 days. Children in the study receive either Biolizin syrup, taken once or twice daily according to age-based dosing for 42 days along with caregiver counseling on responsive feeding, or they receive only the caregiver counseling without the supplement. Caregivers attend clinic visits at Day 0, Day 7, Day 21, and Day 42 to receive counseling, report feeding behavior, and monitor adherence. Use of other zinc products or appetite stimulants is not allowed. Participants undergo measurements of weight and height at each visit, and caregivers complete validated questionnaires on feeding difficulties and eating behavior. Safety is monitored through adverse event review and laboratory tests at baseline and Day 42, including possible serum zinc levels. The main outcome measured is the change in feeding difficulty score from the start to Day 42. Secondary outcomes include changes in eating behavior subscales, growth indices, serum zinc, and overall safety throughout the study.

Researchers are evaluating the effectiveness and safety of two treatments, Bemnifosbuvir-Ruzasvir (BEM/RZR) and Sofosbuvir-Velpatasvir (SOF/VEL), for adults with chronic hepatitis C virus (HCV) infection. This phase 3 randomized, controlled, open-label study aims to compare these antiviral drugs in people with either no liver cirrhosis or compensated liver cirrhosis, including those who might also have HIV-1 under controlled conditions. Participants will receive either BEM/RZR tablets once daily for 8 weeks if they do not have cirrhosis, or for 12 weeks if they have compensated cirrhosis. The comparison group will take SOF/VEL tablets once daily for 12 weeks. Both treatments are fixed-dose combinations taken orally. The study is randomized with a single masking design, and participants are followed throughout the treatment and post-treatment periods. During the study, participants will have their hepatitis C viral load measured to determine if the virus is reduced below quantifiable levels at 24 weeks and 12 weeks after finishing treatment. Researchers will also monitor for any virologic failure and assess safety throughout the study. The total participation period includes treatment duration plus follow-up until 24 weeks, with careful adherence and safety monitoring conducted by the research team.