Skopje

Researchers are evaluating the safety, tolerability, pharmacometrics, and effectiveness of Claseprubart (DNTH103) in adults with multifocal motor neuropathy (MMN) in this Phase 2 clinical trial. The study aims to understand how this drug works and its safety profile compared to a placebo in people diagnosed with definite or probable MMN who have shown responsiveness to immunoglobulin (Ig) treatment. Participants receive an initial intravenous loading dose on Day 1, followed by subcutaneous doses of Claseprubart or placebo every two weeks from Week 1 through Week 15. This randomized, double-blind, placebo-controlled setup allows researchers to carefully compare the effects of the drug versus placebo over the course of the treatment period. Throughout the study, participants will be monitored for any treatment-emergent adverse events or serious adverse events from baseline to Week 17. Researchers will collect safety and efficacy data, including pharmacometric assessments, to evaluate the drug's impact. Participants are involved in regular assessments and follow-ups during this time to ensure thorough observation and data collection related to safety and treatment response.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are conducting a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and effectiveness of navenibart in preventing attacks in adults and adolescents with type 1 or type 2 hereditary angioedema (HAE). This study compares navenibart to a placebo to determine its ability to reduce the frequency of HAE attacks. Participants will receive either navenibart or a placebo as subcutaneous injections. The study treatment period lasts for 6 months, during which the number of investigator-confirmed HAE attacks will be tracked and analyzed to evaluate the treatment's impact. During the trial, participants will be closely monitored for HAE attack frequency and safety. Researchers will collect data on the number of attacks from Day 1 through Day 181 to measure treatment efficacy. Safety assessments will also be conducted throughout the study to ensure participant well-being.

Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Researchers are studying participants with Relapsing Multiple Sclerosis (RMS) to compare how the body processes ublituximab when given as a subcutaneous (under the skin) injection versus an intravenous (IV) infusion. This Phase 3, open-label, parallel-group, multicenter study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, radiological, and clinical effects of these two methods of administering ublituximab. The purpose is to understand if the subcutaneous form is not inferior to the intravenous form. Participants will receive ublituximab either by IV infusion or subcutaneous injection. The study includes ongoing treatment and monitoring to assess how the drug behaves in the body and its effects. The comparison focuses on the area under the curve (AUC) of ublituximab concentration from the start of treatment through 24 weeks. During the study, participants will undergo assessments including clinical evaluations and radiological tests to monitor disease status and treatment effects. Safety and pharmacodynamic measures will be recorded throughout the study. The total treatment and observation period includes at least 24 weeks of follow-up to evaluate the drug's profile and impact on participants with RMS.

This research focuses on adults with congenital heart disease (ACHD), a group at risk for heart failure, which is a leading cause of illness and death in this population. The study investigates the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i), a newer type of medication that has shown benefits in treating heart failure related to left ventricular dysfunction. The goal is to better understand how these drugs are prescribed, their safety, tolerability, and potential positive effects on heart failure outcomes specifically in ACHD patients. The study collects real-world data from international centers on adults with congenital heart defects who have started treatment with any type or dose of SGLT2 inhibitors. Data will be gathered from medical records covering one year before starting SGLT2i therapy through the most recent follow-up. No additional interventions will be performed; the registry only observes routine clinical care and treatment with SGLT2i to assess if this therapy may slow down clinical worsening and improve heart failure-related outcomes in ACHD patients. Participants will have their health information reviewed from electronic health records, including prescription patterns, safety, and how well they tolerate SGLT2i treatment. Researchers will monitor heart failure-related outcomes over time based on these data. The study includes adults aged 18 years or older with congenital heart disease who have begun SGLT2i treatment, and it does not require extra procedures beyond usual medical care.

Researchers are studying ischemic stroke cases in patients who are taking oral anticoagulants for atrial fibrillation or other heart rhythm problems that can cause clots. This study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate short- and long-term outcomes related to different secondary prevention strategies to prevent stroke recurrence. The study includes two parts: a retrospective phase (ASPERA-R) and a prospective phase (ASPERA-P), involving multiple centers worldwide. The University of L'Aquila coordinates data collection, analysis, and management. The retrospective part (ASPERA-R) will collect data for 5 years from the study start, with centers having 6 months to enter existing patient data. The prospective part (ASPERA-P) will enroll patients for 2 years after study approval, followed by 5 years of follow-up. Participants must have had an acute ischemic stroke while on oral anticoagulants, with confirmed imaging showing stroke lesions. The study will observe different secondary prevention treatments, including continuing the same anticoagulant or switching therapies, to compare outcomes. Participants undergo baseline assessments of demographics, clinical status, and brain imaging at the time of their stroke. Researchers will track new strokes or transient ischemic attacks at 90 days, 1 year, and 5 years after the initial stroke. They will also monitor safety events like bleeding complications and other major ischemic events such as heart attacks. Data collection includes ongoing clinical evaluations and imaging studies to identify factors linked with stroke recurrence and treatment safety.

This research aims to assess whether caudal anesthesia compared to dorsal penile block anesthesia affects the rate of surgical complications in boys undergoing repair for distal hypospadias, a common congenital genital malformation. The study addresses gaps in current knowledge caused by limitations in previous retrospective studies, seeking to clarify if caudal blocks lead to higher rates of urethrocutaneous fistulas and glans dehiscence after surgery. This pilot trial will test the feasibility of a larger randomized controlled trial to confirm these findings. Participants will be randomly assigned to receive either a caudal block anesthesia or a dorsal penile block anesthesia during hypospadias repair surgery. Both groups will have anesthesia induced by inhalation of air/nitrous oxide and sevoflurane. The caudal block involves injecting bupivacaine into the sacral spinal canal, while the dorsal penile block involves injecting bupivacaine into the dorsal part of the penis. All patients will receive standard postoperative medications including dexamethasone, ondansetron, acetaminophen suppository, intravenous morphine, and oral medications such as morphine, Ditropan, Tylenol, ibuprofen, and trimethoprim as prescribed. During the study, researchers will monitor participants for postoperative complications over one year to evaluate safety and effectiveness. Assessments include tracking complication rates such as urethrocutaneous fistulas and glans dehiscence. Parents will administer prescribed medications at home, and the study includes follow-up to monitor recovery and any adverse events. The total participation involves surgery and a one-year observation period to capture outcomes fully.

This research aims to evaluate whether the drug CYB704, a proposed biosimilar to Ocrevus, works similarly to the original Ocrevus treatment in adults with relapsing multiple sclerosis (RMS). The study focuses on comparing how CYB704 is distributed in the body, its treatment effects, and side effects to those of Ocrevus. It is a Phase 3 clinical trial that seeks to demonstrate pharmacokinetic similarity and assess efficacy, safety, pharmacodynamics, and immunogenicity. Participants will receive either CYB704 or Ocrevus (from the US or EU) through intravenous infusions. The study is randomized, double-blind, and parallel-group in design. Participants will undergo at least 15 treatment visits involving drug administration and clinical checkups. Regular magnetic resonance imaging (MRI) scans will be performed to monitor disease activity and treatment effects. Throughout the study, participants will have various assessments including neurological evaluations and safety monitoring. The primary outcome measure focuses on the area under the concentration-time curve during weeks 1 to 3 and weeks 3 to 25 to assess drug pharmacokinetics. The total involvement includes treatment visits, MRI scans, and clinical tests to provide comprehensive data on the effects and safety of the treatments over time.

Researchers are evaluating the effects of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing coronary artery bypass grafting (CABG). This international, multi-center randomized trial named ROMA:Women aims to determine whether MAG improves major heart and brain-related events and quality of life compared to SAG. The study includes 2,300 women to examine outcomes like death, stroke, heart attacks, repeat surgeries, and hospital stays, along with quality of life and mental and physical health symptoms in a subgroup of 500 participants. Important patient subgroups such as age, diabetes status, race, surgical techniques, and type of arterial grafts will also be analyzed. Participants will be randomly assigned to receive either single arterial grafting, where the left internal thoracic artery is connected to the heart's left anterior descending artery along with venous grafts, or multiple arterial grafting, where an additional arterial graft such as the right internal thoracic artery or radial artery is used for other coronary branches, plus other grafts as needed. The trial leverages existing infrastructure and continues enrollment with additional sites to reach its target sample size. Both treatment arms follow the same randomization, interventions, and follow-up protocols as the parent ROMA trial. During the study, researchers will monitor participants for at least 2.5 years after surgery to track major cardiac and cerebrovascular events and assess disease-specific and generic quality of life measures using questionnaires such as the Seattle Angina Questionnaire and PROMIS-29. The trial will collect data through clinical assessments and questionnaires to evaluate health outcomes and symptom changes. Safety and effectiveness will be closely followed to understand the impact of the two grafting methods in women undergoing CABG.