Shah Alam

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety, effectiveness, and how the body processes VX-01 as an oral treatment for people with moderate to severe Non-Proliferative Diabetic Retinopathy (NPDR) without clinically significant diabetic macular edema (CI-DME). This Phase 2, multi-center study compares VX-01 to a placebo over 52 weeks, aiming to see if daily doses can improve the condition in adults with Type 1 or Type 2 diabetes. Participants will be randomly assigned to receive either VX-01 tablets (150 mg twice daily) or matching placebo tablets twice daily for one year. The study groups are balanced based on the presence of proliferative diabetic retinopathy and blood sugar control levels. After the 52-week treatment period, there is a 12-week follow-up phase where all participants continue to be monitored without the study drug. During the study, participants will have regular eye exams, including imaging and visual acuity tests, and blood tests to monitor safety and treatment effects. Researchers will track adherence to medication and evaluate outcomes such as vision changes and diabetic retinopathy progression. Safety and tolerability will also be closely observed throughout the treatment and follow-up periods, with total participation lasting about 64 weeks.

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. The study aims to understand the safety of a treatment called finerenone when used together with standard medicines called ACE inhibitors or angiotensin receptor blockers (ARBs). These medicines help control kidney function and blood pressure by targeting a system called the renin-angiotensin-aldosterone system (RAAS), which is often overactive in CKD. Finerenone may help control this system more effectively alongside ACEI or ARB. Participants will receive finerenone in doses adjusted by age and body weight for up to 18 months. The study is open-label and single-arm, meaning all participants receive the treatment. Some participants already took finerenone in a previous study and will continue, while others will start anew. The treatment period lasts about 540 days with a 1-month follow-up after the last dose. Visits are planned at least 12 times for new finerenone users and 8 times for continuing users. During visits, participants will have their blood pressure, heart rate, temperature, height, and weight measured. Blood and urine samples will be collected to monitor kidney function and protein levels. Heart function will be checked using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use, side effects, and well-being. Researchers will track any medical problems during the study and check health about 30 days after treatment ends. The main focus is safety, including monitoring adverse events, potassium levels, and blood pressure changes over about 19 months.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are investigating a new treatment approach for children aged 6 months to less than 18 years who have chronic kidney disease (CKD) and proteinuria, a condition where the kidneys leak protein into the urine. CKD causes the kidneys to work less effectively, leading to waste buildup and high blood pressure. Current treatments include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB), which help regulate a system involved in blood pressure and kidney function. However, these treatments do not work for all patients. This study is focused on seeing if adding finerenone to ACEI or ARB can better control this system and improve kidney function. Participants will receive either finerenone or a placebo for about 180 days, alongside their usual ACEI or ARB medication. The study will adjust finerenone doses based on age and body weight. Before starting treatment, participants will attend up to two screening visits within 104 days to check eligibility. During the treatment phase, participants will make at least seven visits to the study site for ongoing care and monitoring. Throughout the study, doctors will measure participants' blood pressure, heart rate, temperature, height, and weight. They will collect blood and urine samples to monitor kidney function and protein levels. Heart health will be checked using electrocardiograms and echocardiography. Participants or their parents will answer questions about medication use, side effects, and how they feel. Researchers will track any medical problems that occur during the study and will follow up about 30 days after treatment ends. The main goal is to see how much the protein in urine changes from the start to day 180.

Researchers are evaluating the effect of tozorakimab, added to standard care, in adults hospitalized with viral lung infection who need supplemental oxygen. The study focuses on preventing death or progression to invasive mechanical ventilation or extracorporeal membrane oxygenation by day 28. This is a Phase III, multicenter, randomized, double-blind trial comparing tozorakimab to placebo in patients with viral lung infection causing acute respiratory failure. Participants will receive a single intravenous dose of either tozorakimab or a matching placebo on the first day of the study. Both groups continue to receive standard care for their viral lung infection. The study is designed to assess the safety and efficacy of tozorakimab as an add-on therapy in this patient population. Throughout the study, researchers will monitor participants for survival and the need for invasive mechanical ventilation or ECMO up to 28 days after treatment. The main outcome measured is the proportion of patients who die or require mechanical ventilation or ECMO by day 28. Participants will be closely observed during hospitalization, with data collected on their respiratory status and treatment outcomes to evaluate the study drug's impact and safety.

Researchers are evaluating a new approach to lipid lowering in patients with cardiovascular diseases such as acute coronary syndrome, atherosclerosis, and hypercholesterolemia. This multinational study involves hospitalized patients who have experienced a Type I myocardial infarction. The trial compares the effects of an early versus late multifaceted intervention aimed at improving guideline-directed lipid lowering therapy. The study has two phases over 12 months. In phase I (0-6 months), one group receives the intervention immediately at baseline, while the other group receives standard care and serves as a control. In phase II (6-12 months), the control group then receives the intervention. The intervention includes a patient-and-clinician cholesterol score card to track LDL cholesterol levels, adherence to therapy, management decisions, and prescribed treatments. Risk assessment for recurrent events is also performed using an online calculator and Lp(a) measurements, with results shared with participants and their clinicians. Participants are monitored through routine clinical visits where the score card is updated. Lipid profiles are sent to primary care physicians at 6 weeks, 3 months, and 6 months. The main outcome measured is the proportion of patients achieving an LDL cholesterol level below 1.4 mmol/L at 6 months. The study includes safety monitoring and follow-up to assess the impact of the intervention over a full year.

Researchers are studying the presence and characteristics of Streptococcus pneumoniae bacteria in the noses of Malaysian children aged 5 years and younger. The study aims to understand how common this bacteria is, which types are circulating, and how resistant these bacteria are to antibiotics, especially after Malaysia introduced pneumococcal conjugate vaccines (PCVs) into its national immunization program. This research focuses on healthy and mildly symptomatic children from urban and semi-urban areas in Kuala Lumpur, Selangor, and Negeri Sembilan. Participants will have a nasopharyngeal swab collected to detect the bacteria. Their demographic information and vaccination history will be recorded through a standardized form with consent from their parents or guardians. Laboratory tests including bacterial culture, antimicrobial susceptibility testing, and whole-genome sequencing (WGS) will be performed to identify the specific bacterial types and resistance patterns. The study will compare results across different vaccination statuses, regions, and socioeconomic backgrounds to assess differences in bacteria spread and potential changes in serotype prevalence. During the 18-month study, researchers will focus on the rate of Streptococcus pneumoniae carriage among children up to age 5. Participants will be recruited from community settings like daycare centers and outpatient clinics. The study will use detailed genomic analysis to link bacterial types and resistance to vaccination status. This information will help guide future vaccine strategies and monitor antibiotic resistance in the community.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.