Skopje

Researchers are evaluating the pharmacokinetics PK and safety of subcutaneous SC ublituximab in people with relapsing multiple sclerosis RMS. The study aims to compare how ublituximab is absorbed and tolerated when injected at different sites on the body and when administered using either a prefilled pen device or a syringe. This Phase 2 trial involves adult participants with RMS who meet specific neurological stability and disability criteria. Participants will receive ublituximab SC either by syringe at one of three injection sites or by randomized assignment to receive the drug with either a prefilled pen or a syringe. The study evaluates the relative bioavailability of ublituximab delivered by these two methods over a planned treatment period extending up to 120 weeks, with key assessments occurring up to 12 weeks and beyond. During the study, participants will undergo plasma concentration measurements of ublituximab at various time points to determine drug levels and steady state exposure. Safety will be monitored through tracking treatment-emergent adverse events throughout the study. Participant satisfaction with the SC administration method will also be assessed. This long-term study may involve multiple visits for drug administration, monitoring, and questionnaires, continuing for up to five years.

Researchers are evaluating the effectiveness of claseprubart DNTH103 compared to a placebo in adults with chronic inflammatory demyelinating polyneuropathy CIDP. This Phase 3 study aims to assess treatment outcomes in participants with typical CIDP or certain CIDP variants, focusing on improving disease activity and disability measures. The study consists of several periods Part A includes an open-label phase lasting up to 13 weeks where participants receive an intravenous loading dose of claseprubart followed by subcutaneous injections every two weeks. Part B is a randomized, placebo-controlled, double-blind treatment phase lasting up to 52 weeks for those who respond to treatment in Part A, with participants receiving either claseprubart or placebo subcutaneously every two weeks. Eligible participants may then join an optional open-label extension lasting up to 104 weeks, continuing claseprubart treatment subcutaneously every two weeks, followed by a safety follow-up period of 40 weeks. Participants will undergo regular assessments throughout the study, including evaluations of disease relapse using the Adjusted Inflammatory Neuropathy Cause and Treatment INCAT score, disability scales, grip strength measurements, quality of life, fatigue severity, and antibody levels. Safety monitoring involves tracking adverse events and drug serum concentrations. The total study duration can extend up to approximately 209 weeks, including all treatment and follow-up phases, with careful monitoring of participants neurological stability and treatment responses.

Researchers are evaluating two different doses of CHF10067 zampilimab to assess their effectiveness, safety, and tolerability in adults with idiopathic pulmonary fibrosis IPF. This phase IIb, multicenter, randomized, double-blind, placebo-controlled study involves 240 participants across about 150 sites worldwide. The study focuses on changes in lung function, specifically percent predicted forced vital capacity ppFVC, at Week 24. Participants will be randomly assigned to one of three groups receiving either one of two doses of CHF10067 or a placebo, all administered via intravenous infusion. The study treatment is given over a 24-week period, with evaluations at several points including Weeks 6, 12, 18, 24, and 30. This design allows comparison of the drug doses against placebo while monitoring drug levels and effects over time. During the study, participants will undergo lung function tests, oxygen saturation measurements, and complete questionnaires related to living with pulmonary fibrosis. Blood samples will be taken to measure drug concentration. Various outcome measures such as absolute and relative changes in lung function and symptom assessments will be collected up to Week 30. Safety and tolerability will be closely monitored throughout the study period.

Researchers are studying the use of sodium-glucose cotransporter 2 inhibitors SGLT2i in adults with congenital heart disease ACHD, focusing on how these drugs are prescribed and their safety, tolerability, and possible benefits for heart failure-related outcomes. Heart failure is a leading cause of illness and death in this group, but treatment options are limited. SGLT2i are a new class of medications shown to help in conventional left ventricular heart failure and may work through multiple pathways to improve heart function. This international registry collects real-world data from adult ACHD patients who have been treated with any type and dose of SGLT2i. Data will be gathered from one year before starting the medication up to the most recent follow-up. There are no interventions or changes to care for participants since data collection uses routine clinical records. The registry aims to understand prescription patterns, side effects, discontinuation rates, and heart failure-related clinical and laboratory outcomes. Participants will contribute data from their medical records, including clinical parameters like weight, blood pressure, heart rate, oxygen saturation, laboratory values, echocardiography measurements, and exercise test results. Researchers will monitor safety and tolerability outcomes such as side effects, complications, and mortality over an average follow-up of one year. This study seeks to evaluate the impact of SGLT2i therapy on heart failure progression in ACHD patients through comprehensive real-world observation.

Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of LAquila. The study has two parts ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.

Hypospadias is a common genital malformation in boys that is usually treated with surgery. Researchers are evaluating whether caudal anesthesia compared to dorsal penile block anesthesia affects the rate of surgical complications like urethrocutaneous fistulas and glans dehiscence after hypospadias repair. This pilot randomized controlled trial aims to determine if one anesthesia method leads to fewer complications and to test the feasibility of a larger study. Participants aged 6 to 48 months undergoing distal hypospadias repair will be randomly assigned to receive either a caudal block or a dorsal penile block anesthesia. Both methods use inhalation induction with airnitrous oxide and sevoflurane followed by an injection of bupivacaine without epinephrine. Additional pain management includes fentanyl, dexamethasone, ondansetron, acetaminophen, morphine, and post-discharge medications such as oral morphine, Ditropan, Tylenol, ibuprofen, and trimethoprim until catheter removal. During the study, children will be closely monitored for postoperative complications for up to one year. Researchers will assess safety and complication rates, medication usage, and recovery progress. This double-blind, randomized trial will provide detailed data on the impact of anesthesia type on surgical outcomes and help guide future treatment decisions.

Researchers are evaluating the outcomes of different coronary artery bypass grafting techniques in women with heart disease. The trial compares multiple arterial grafting MAG to single arterial grafting SAG to see if using multiple arterial grafts improves major heart and brain-related events and quality of life. This international randomized clinical trial includes 2,300 women to assess differences in survival, stroke, heart attacks, repeat surgeries, and hospital readmissions, as well as physical and mental health. Participants will be randomly assigned to one of two groups. One group receives a single arterial graft using the left internal thoracic artery plus additional venous grafts. The other group receives multiple arterial grafts, including the left internal thoracic artery and at least one other arterial graft such as the right internal thoracic artery or radial artery, with possible additional arterial grafts. The study uses the infrastructure of an existing trial and follows patients for at least 2.5 years after surgery. During the study, researchers collect data on major adverse cardiac and cerebrovascular events, along with quality of life measured by general and disease-specific questionnaires. Physical and mental health symptoms are also assessed. Follow-up includes tracking deaths, strokes, heart attacks, repeat procedures, and hospital stays. The trial aims to provide detailed information on outcomes and quality of life in women undergoing coronary bypass surgery over a long-term period.

The registry focuses on patients with venous thromboembolism VTE, including those often excluded from typical clinical trials such as pregnant women, elderly patients, and those with serious health conditions. It aims to improve medical knowledge and patient care by collecting detailed data on these patients clinical status and treatment outcomes. The project also seeks to develop predictive scores to identify patients at higher risk of complications from thromboembolic disease. This observational registry collects extensive information on patients diagnosed with VTE, including details on coexisting conditions, antithrombotic treatment type, dose, and duration, as well as outcomes during the first three months of therapy. It captures data on VTE recurrences, bleeding complications, and deaths, providing insights into real-world treatment and patient management. Participants provide informed consent and are followed for at least three months to monitor clinical outcomes. The registry supports physicians by giving access to data on patients with similar profiles to help manage complex cases. The main outcomes measured include VTE events and complications over a three-year period, supporting ongoing improvements in patient care and risk assessment.

Researchers are studying cancer-related cardiovascular toxicity, which includes heart problems caused by chemotherapy drugs and radiotherapy in people with cancer. The goal is to identify ways to predict, prevent, and treat heart damage related to cancer treatments. This observational study aims to better understand these cardiovascular risks in cancer patients to improve care. Participants include those newly diagnosed with breast cancer receiving anthracycline-based chemotherapy with or without radiotherapy, trastuzumab, or other anticancer drugs. A subgroup will have their risk assessed using the HFA-ICOS risk score. The study involves following patients at baseline, 3 months, and 1 year to monitor heart health and treatment effects. During the study, participants will attend follow-up visits for assessments, including heart function and survival outcomes. Researchers will track all-cause mortality, cardiovascular mortality, and cancer therapy-related cardiovascular toxicity over about three years. The study collects data to help better understand and manage heart risks linked to cancer treatments.

This research aims to evaluate the overall perioperative haemostatic effectiveness of Nuwiq, a recombinant factor VIII, combined with emicizumab prophylaxis in male patients aged 12 and older with severe haemophilia A undergoing major surgery. The study is a prospective, open-label, multinational, multicentre, single-arm trial focused on patients receiving emicizumab who require additional FVIII during surgery. Participants will receive Nuwiq intravenously following the approved prescribing information. Treatment will be administered every 8 to 24 hours as needed until adequate wound healing is achieved. If necessary, treatment may continue for at least another 7 days to maintain factor VIII plasma levels between 30 and 60 IUdL. This regimen aims to provide effective haemostatic cover throughout the surgical and healing period. Throughout the study, participants will be monitored during surgery and until wound healing is complete, typically within 30 days after surgery. Assessments include measuring haemostatic efficacy during and after surgery, blood product transfusion levels, factor VIII plasma levels, thrombin generation, and monitoring for thrombotic events, inhibitor formation, and adverse events. The study duration covers the surgical procedure and a follow-up period to ensure safety and treatment response.