Chandigarh

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). This prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

Researchers are evaluating a specially developed Neuro-cognitive and psychosocial intervention module designed to help people with drug-resistant epilepsy (DRE) improve their quality of life. This study addresses cognitive and psycho-social issues common in epilepsy, focusing on a broader range of assessment tools and intervention methods than previous research in the Indian context. The study is a hospital-based randomized control trial including 60 patients aged 18 to 45 years, aiming to test the module's effectiveness in improving quality of life. The intervention module includes a pen-and-paper cognitive retraining program covering attention, visual processing, memory, information processing, and executive functions. It also involves cognitive-behavioral interventions such as activity scheduling, problem-solving, anger management, and addressing stigma and irrational beliefs about epilepsy. Additionally, marital and family counseling is provided to support understanding of the illness, treatment, and family dynamics. Patients are randomly assigned to either the intervention group receiving the module or a control group with follow-up only. Participants undergo pre- and post-intervention neuropsychological and psychosocial assessments, with follow-up outcome evaluations at 3 to 6 months after recruitment. Researchers will measure improvements in quality of life using various clinical, neuropsychological, and psychosocial variables. Statistical analyses will compare group differences and explore correlations among variables to assess the module's impact on patients with drug-resistant epilepsy.

Researchers are evaluating treatments for acute allergic bronchopulmonary aspergillosis (ABPA), a condition complicating asthma. This Phase 3 trial aims to compare the effects of prednisolone, itraconazole, and their combination on reducing the rate of ABPA or asthma flare-ups one year after treatment. Previous studies showed both prednisolone and itraconazole can be effective, but it is unclear if combining them offers better protection against exacerbations. Participants aged 18 years and older diagnosed with acute ABPA will be randomly assigned to receive either prednisolone alone, itraconazole alone, or both drugs together for four months. Prednisolone will be given as prescribed, and itraconazole will be administered as SUBA-itraconazole. This treatment period is followed by monitoring visits every two months for the first two visits, then every four months for three additional visits, covering a total follow-up period of one year post-treatment. During the study, researchers will collect baseline data including demographics, immune and imaging tests. They will monitor patients regularly for symptoms, lung function, and exacerbations of asthma or ABPA. The main outcome measured is the proportion of participants experiencing an exacerbation within 12 months after completing treatment. Safety and response to therapy will also be carefully assessed throughout the study period.

Researchers are evaluating the safety of the medicine eptacog alfa for stopping heavy bleeding in women after childbirth in India. This phase IV study focuses on women who have severe postpartum hemorrhage (PPH) after delivering babies at 27 weeks or later and who do not respond to uterotonics. The aim is to gather more knowledge about how safe eptacog alfa is when used in these women. During the study, participants will receive one dose of eptacog alfa through an intravenous injection. If this first dose does not stop the bleeding, an additional dose may be given. The treatment is delivered as a single intravenous bolus, and the entire study will last about 30 to 35 days. Participants will be monitored from the day of treatment (baseline) to the end of the study at day 30. Researchers will track the number of thromboembolic events during this period as a primary safety measure. Throughout the study, women will be assessed for any adverse effects and treatment response, ensuring their safety and compliance with the study protocol.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adult patients with relapsed advanced solid tumors. These tumors include non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer. Participants must have no available curative or life-prolonging treatments and have exhausted all effective local therapies. Participants will receive oral AUR107 once daily. The study uses a traditional 3+3 dose escalation design to assess safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The treatment period focuses on finding the best dose and assessing how the drug behaves in the body. During the study, participants will be monitored for dose limiting toxicities and treatment-related adverse events over 28 days. Researchers will evaluate pharmacokinetics parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and half-life at specified days. Safety assessments, disease measurements, and tolerability will be closely followed to understand the effects of AUR107.

Researchers are conducting a Phase 1, open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR108 in adult patients with relapsed advanced lymphomas. This study focuses on patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who have exhausted effective local treatments and have no curative or life-prolonging options available. The trial uses a traditional 3+3 dose escalation design to evaluate AUR108 as a single oral agent. Participants will receive oral AUR108 with a schedule of dosing for 3 days followed by 4 days without dosing each week. The study includes dose escalation to determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The research will monitor treatment-related adverse events and measure drug levels and effects over time. During the study, participants will undergo safety assessments including monitoring for dose-limiting toxicities and treatment-related adverse events, pharmacokinetic evaluations at specified time points, and clinical evaluations for disease response. The study duration averages about one year with ongoing safety follow-up. Researchers will collect data on adverse events, drug concentration, and patient health to evaluate the treatment's safety and dosing parameters.

Researchers are evaluating how well elritercept (TAK-226, KER-050) works in reducing the need for red blood cell (RBC) transfusions in adults with very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require regular blood transfusions. The study is a Phase 3, double-blind, randomized, placebo-controlled trial that also aims to assess the safety and tolerability of elritercept over both short and longer periods, including in adults with high transfusion needs. Participants will be randomly assigned in a 2:1 ratio to receive either elritercept or a matching placebo by subcutaneous injection every 4 weeks. The study includes a Primary Phase lasting 24 weeks and a Secondary Phase lasting an additional 24 weeks, during which participants continue the same treatment. Following these phases, an Extension Phase allows eligible participants to continue treatment until discontinuation or study unblinding. Study visits occur every 2 weeks during the first 6 cycles and every 4 weeks thereafter. Treatment continuation depends on meeting disease assessment criteria every 24 weeks. Participants will undergo various assessments including bone marrow aspirates, transfusion evaluations, and disease status checks throughout the study. Safety follow-up lasts for 8 weeks after the last dose, with visits every 4 weeks during this time. Afterward, long-term follow-up occurs quarterly for up to 5 years or until withdrawal, death, loss to follow-up, or study closure. The main outcome measured is the percentage of participants achieving transfusion independence for at least 8 weeks during the first 24 weeks of treatment.

This research aims to assess the safety and effectiveness of guselkumab treatment in Indian adults with psoriatic arthritis, a chronic autoimmune condition causing joint inflammation. The study focuses on participants who have not responded well to standard therapies, including conventional drugs and biologics. It is a Phase IV, open-label, multicenter study designed to evaluate this treatment in a real-world setting. Participants will receive guselkumab as a subcutaneous injection. The study includes careful screening for tuberculosis before starting treatment, requiring specific tests and chest X-rays to rule out active or latent TB. The treatment phase lasts up to 32 weeks, during which participants will be monitored for any adverse events or serious adverse events. During the study, participants will undergo physical exams, medical history reviews, vital signs checks, and ECGs to ensure medical stability. Women of childbearing potential will have pregnancy tests. Researchers will closely track safety by recording any adverse events over the 32-week period. The study aims to gather comprehensive data on how well guselkumab works and how safe it is for treating psoriatic arthritis in this population.