Country: Slovenia

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  • CT-EU-00041606

    Iptacopan’s effect on adult patients with atypical hemolytic uremic syndrome

    This study is conducted to understand if a medicine called iptacopan (also known as LNP023) is safe and effective in treating a disease called Atypical Hemolytic Uremic Syndrome (aHUS) in adults who have never received a type of medication known as a complement inhibitor. Around 50 adults will be given 200 mg of this iptacopan pill twice a day. The doctors will measure how their illness responds by looking at blood tests, kidney health, how often they need to have their blood cleansed by a machine (dialysis), the progression of their kidney illness, and how they feel energetically and about their quality of life. Side effects of taking iptacopan will be recorded for a year.

    AustriaCzechiaGreeceSlovakiaSloveniaUnited Kingdom
  • Testing the effectiveness of a new drug compared with standard therapy in the treatment of asthma

    This medical research is a year-long study that tests a new asthma medication, called GSK3511294 (Depemokimab), against two other asthma medicines, Mepolizumab and Benralizumab. The trial is intended for teens and adults who have a severe form of asthma called ‘eosinophilic phenotype.’ The aim is to see if switching to GSK3511294 from Mepolizumab or Benralizumab keeps the severity and frequency of asthma attacks under control equally or better. Participants will keep taking their regular non-biological asthma medications throughout the trial. The study will look at the number of severe asthma attacks a patient experiences in a year, which is defined here as any worsening of asthma requiring steroids, a hospital visit, or an emergency room trip. They will also check for changes in their quality of life and their asthma control using questionnaires, and measure the capacity of their lungs with a breathing test.

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  • Study on a new combination therapy for active ulcerative colitis

    This study aims to assess the effectiveness and safety of new combination therapy with JNJ-78934804 (Guselkumab/Golimumab) in comparison to guselkumab and golimumab administred alone for individuals with moderately to severely active ulcerative colitis. Participants who have shown inadequate response, loss of response, or intolerance to approved advanced therapies will be included. The trial includes various treatment groups: placebo, Guselkumab, Golimumab, and different doses of JNJ-78934804. All participants meeting inadequate response criteria will be escalated to an active treatment. The study will last for 48 weeks and the progress will be tracked over this period. The primary focus is to evaluate the efficacy and safety of the different doses of new therapy in managing ulcerative colitis over the course of the study.

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  • Testing Osilodrostat treatment in Cushing’s disease in children aged 6 years to 17 years

    This study involves investigating a drug called osilodrostat in young individuals with Cushing’s Disease. The primary focus is to observe how the drug behaves and moves within the body, its impact on the disease, and its safety. The trial spans approximately 12 weeks, beginning with a period of abstaining from other medications that could influence cortisol levels, a hormone that becomes elevated in individuals with Cushing’s Disease. If positive effects persist after 12 weeks, the testing period may extend for an additional 9 months to evaluate the long-term influence of the drug on the disease and its safety. The study aims to assess the drug’s efficacy by comparing urine cortisol levels at the start and end of the trial.

    BelgiumBulgariaItalySloveniaUnited Kingdom
  • Examining midostaurin and chemotherapy for new child leukemia patients

    This research study is checking out a medication named Midostaurin. It is aimed at kids who have a certain type of blood cancer (FLT3-mutated Acute Myeloid Leukemia). The drug will be combined with the standard chemotherapy treatment. The researchers will look at how safe this combination is and how well it works. At the same time, they’ll examine how the body absorbs and gets rid of the medication. The study will have two parts. The first one is to figure out the best dosage, and the second one is to confirm how safe and effective it is. Both phases include 2 stages of chemotherapy to defeat the disease, 3 steps of follow-up chemo to make sure the disease doesn’t return, and a year-long treatment with Midostaurin on its own. If at any phase of the treatment, the disease comes back, the therapy will be stopped.

    AustriaCzechiaGermanyItalyPolandSlovenia
  • Testing tovorafenib in treating low-grade glioma

    This study is a comparative test between tovorafenib (DAY101) and the standard chemotherapy typically administered to children with low-grade glioma, a specific type of brain tumor. The experiment involves approximately 400 children who have not yet received treatment for their glioma. The participants will be divided into two groups. In the first group, children will be administered DAY101, taking it every 28 days until one of the following events occurs: they no longer benefit from the treatment, it becomes unsafe, they choose to leave the experiment, or the experiment concludes. In the second group, children will receive one of three common chemotherapy drugs selected by their doctor, and they will continue with the treatment until similar circumstances prompt a change, as outlined for the first group. If the tumor continues to grow while on DAY101 but the treatment remains beneficial, participants can continue taking it. Likewise, if the tumor continues to grow while on chemotherapy, participants can stop and transition to DAY101.

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  • Testing growth hormone somapacitan effectiveness for kids with growth hormone deficiency

    This global trial evaluates the efficacy and safety of a once-weekly growth hormone treatment, NNC0195-0092 (somapacitan), compared to a daily treatment in growth hormone-deficient children. The trial, with multiple phases, assesses growth rates, treatment safety, and impact on quality of life. It includes children aged 30 months to 10 years, focusing on those new to growth hormone therapy. The study aims to offer a potentially more convenient treatment regimen, enhancing the lives of children and families managing growth hormone deficiency.

    AustriaSlovenia
  • Combination therapy trial for moderately to severely active Crohn’s disease

    The study examines a combination therapy using guselkumab and golimumab in individuals with active Crohn’s Disease. It aims to compare the effectiveness of this dual approach to individual treatments, focusing on reducing disease symptoms and improving patients’ quality of life. The study’s goal is to offer new hope and better management strategies for those battling this challenging condition.

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  • Thrombolysis therapy in treating acute Pulmonary Embolism

    This study aims to evaluate a reduced dose of thrombolytic treatment for patients with intermediate-high-risk acute pulmonary embolism. It compares the new treatment approach with a placebo to assess effectiveness and safety. The study’s focus is on reducing the risk of major and intracranial bleeding associated with full-dose thrombolytic treatment. Participants will receive either the experimental treatment or a placebo, alongside standard anticoagulation therapy. The primary goal is to determine the efficacy and safety of the reduced dosage at day 30, with long-term follow-up assessments planned. This research is crucial for improving treatment options for patients with this serious lung condition.

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  • Assessing the efficacy of atuliflapon in uncontrolled asthma relief

    This study is looking at atuliflapon, a new medication, for adults with moderate to severe uncontrolled asthma. The trial is a Phase 2 study, which means it’s testing how effective and safe atuliflapon is. About 1,102 adults who are already using asthma medications will be part of this study. They will take atuliflapon or a placebo once a day for 12 weeks. The goal is to see if atuliflapon can help reduce asthma attacks and improve breathing in people whose asthma isn’t well-controlled with their current treatments.

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  • Exploring physical activity and joint health in Haemophilia A patients using efanesoctocog alfa

    This study is called FREEDOM, and it’s investigating how physical activity and joint health are impacted in people aged 12 and above who have severe Haemophilia A, a bleeding condition. These people are treated with a drug called efanesoctocog alfa once a week over a two-year period. Participants will wear a device that tracks their activity, and they will also keep an electronic diary recording any bleeding, pain, injuries they have and how much of the drug they’re taking. The study is mainly comparing how physical activity changes over the two-year period, but it’ll also examine changes in joint health, occurrences of bleeds, injuries, and pain, along with the general safety of the drug.

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  • A new trial of treatment of amyotrophic lateral sclerosis with masitinib and riluzole

    This clinical trial is investigating the effects of masitinib in combination with riluzole on patients with ALS, a progressive neurodegenerative disease. The study aims to determine if masitinib can provide neuroprotection and slow the disease’s progression by modulating neuroinflammatory responses in the central and peripheral nervous systems. Participants will initially receive masitinib orally at a starting dose, which will be adjusted based on safety evaluations. The treatment’s efficacy will be monitored through clinical assessments, including ALS functional rating scales, quality of life questionnaires, and physical tests like breathing capacity and muscle strength. The trial is double-blind, meaning neither participants nor investigators know who receives masitinib or the placebo, ensuring unbiased results. The ultimate goal is to discover a treatment that can improve survival and life quality for those afflicted with ALS.

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  • Alteplase low-dose trial for acute pulmonary embolism care

    In this trial, participants with a specific type of lung clot called intermediate-high-risk acute pulmonary embolism are given a lower dose of Alteplase, a medication that dissolves blood clots. The study compares the effects of this reduced dose to a non-active placebo to see if it can reduce clot-related risks without increasing bleeding, especially in the brain. The treatment involves a short intravenous injection and is tested alongside standard anticoagulants. Success is measured by patient health 30 days after the treatment, with an eye on long-term outcomes like survival and heart function up to two years later.

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