Clinical trials located in

Genova

Genova city is located in Italy. Currently, 13 clinical trials are being conducted in this city.

  • CT-EU-00121560

    Study of the safety and effectiveness of GLSI-100 in patients with HER2-positive breast cancer

    The study concerns the treatment of patients with HER2/neu-positive breast cancer. Treatment will include GLSI-100 immunotherapy and comparison to placebo. GLSI-100 consists of GP2 peptide and GM-CSF, protein substances that are designed to strengthen the body’s immune response, i.e. natural protection against diseases.

    The aim of this study is to determine how effective and safe GLSI-100 therapy is compared to placebo in preventing breast cancer recurrence after standard treatment. The study is aimed at people at high risk of disease recurrence who have completed both preoperative and postoperative therapy based on trastuzumab, a drug used to treat breast cancer.

    The study will assess invasive breast cancer-free survival (i.e. the time from the first dose of the drug to the moment of disease recurrence or death from any cause), invasive disease-free survival (i.e. the time from the first dose of the drug to the moment of any disease recurrence or new cancer), remote disease (i.e. time until disease recurrence in a place other than the breast or death).

    The study also includes an assessment of the participants’ quality of life both at the beginning and over the next 36 months, as well as an analysis of the body’s immune response to treatment.

  • Comparison of Olorofim and AmBisome® for Treating Invasive Aspergillosis in Patients Who Cannot Use Azole Therapy

    This study focuses on patients dealing with a serious fungal infection called Invasive Aspergillosis (IA). This infection is known to be particularly dangerous for people with weakened immune systems. Two drugs will be compared in this study: Olorofim (also known as F901318) and AmBisome® (liposomal amphotericin B). These drugs are used to treat patients who have a confirmed or suspected IA infection.

    AmBisome® is an established treatment, while Olorofim is a newer medication that works differently. This new drug aims to provide an alternative for patients who don’t respond well to existing therapies.

    The purpose of this study is to compare the effectiveness and safety of Olorofim with AmBisome®, followed by standard care according to medical guidelines. Patients will receive one of the treatments, and their response will be monitored over several months.

    Patients will start with either Olorofim or AmBisome® for a set period, then switch to the standard care recommended by their doctors. This approach allows researchers to understand how well each treatment works and what side effects might occur.

    Participation includes regular follow-ups and assessments to monitor the patient’s health, response to the medication, and any potential side effects. The ultimate goal is to find the best possible treatment for IA, improving outcomes for patients affected by this serious fungal infection.

    • AmBisome®
    • olorofim
  • Study on Alogabat for Children and Teens with Angelman Syndrome

    This study is investigating a medication called Alogabat for children and adolescents aged 5-17 years who have Angelman Syndrome with a specific genetic deletion. The research will explore how different doses of Alogabat affect the body by measuring its concentration over time and observing any changes in brain activity and safety outcomes. The study includes several phases where doses are adjusted based on early results. This research aims to determine Alogabat’s effectiveness in treating symptoms of Angelman Syndrome in younger populations.

    • Alogabat
  • Baricitinib study in children with juvenile idiopathic arthritis

    This clinical trial is designed to test whether Baricitinib is safe and effective in the treatment of systemic juvenile idiopathic arthritis in children aged 1 to 18 years. Participants will be assigned to one of two groups. In the first group, some participants will receive Baricitinib and others Tocilizumab as the reference drug. In the second group, all participants will receive Baricitinib.

    The primary objective of the study is to evaluate the percentage of participants who experience at least a 30% improvement in disease symptoms after 12 weeks of treatment according to the modified American College of Rheumatology Pediatric Response Criteria (PediACR30). Baricitinib is administered orally and Tocilizumab is administered by subcutaneous injection.

    • Tocilizumab
    • baricitinib
  • Study of sarilumab in the treatment of juvenile idiopathic arthritis in children and adolescents

    This is a trial that aims to find the right dose of a drug called sarilumab for treating children and teenagers aged 1 to 17 years old with Systemic Juvenile Idiopathic Arthritis. Sarilumab is given as an injection under the skin. The main goal is to understand how the body processes this drug in young patients, so they can receive an adequate dose for treating their condition.

    The study will last for about 166 weeks, which is a little over 3 years. It starts with a 4-week screening period, followed by a 12-week treatment phase where the patients will receive repeated doses of sarilumab. After that, there is a 144-week extension phase where the patients can continue receiving the drug, and finally a 6-week follow-up period.

    During the first 12 weeks, the researchers will closely monitor the levels of sarilumab in the patients’ blood to understand how their bodies handle the drug. They will look at the maximum concentration reached, the total amount of drug exposure over time, and the levels just before each new dose. This information will help them determine the right dose and dosing schedule for children and adolescents with Systemic Juvenile Idiopathic Arthritis.

    In addition to studying the drug levels, the researchers will also evaluate the effectiveness of sarilumab in reducing the symptoms of this condition and monitor any potential side effects to ensure the drug is safe for long-term use in this age group.

    • Sarilumab
  • Study of ustekinumab and guselkumab in young patients with juvenile psoriatic arthritis

    This here clinical trial is aimin’ to study two different medicines, ustekinumab and guselkumab, for treatin’ a condition called juvenile psoriatic arthritis. This is a type of arthritis that affects young’uns and causes joint pain, swellin’, and stiffness.

    The study will have two groups, one group takin’ ustekinumab and the other takin’ guselkumab. These medicines work by targetin’ certain proteins in the body that cause inflammation, which is the root cause of the arthritis symptoms.

    The main goal of the study is to see how well these medicines work in reducin’ the symptoms of juvenile psoriatic arthritis, like joint pain and swellin’. The study will also look at how the body handles these medicines and if they cause any side effects.

    The study will last for about a year and a half, with regular check-ups and assessments to monitor the participants’ progress.

    • Ustekinumab
    • Guselkumab
  • To evaluate a combination of 3 different drugs versus 2 other drugs in the treatment of patients with melanoma

    This study compares two different approaches to treating advanced melanoma, a type of skin cancer that has spread to other parts of the body. This study is specifically aimed at patients with a gene mutation called BRAF who have previously received treatment with drugs such as nivolumab or pembrolizumab.

    One therapeutic approach involves taking three study drugs: pembrolizumab administered intravenously every 3 weeks, along with encorafenib and binimetinib taken orally daily at home. The second approach involves taking two study drugs: ipilimumab and nivolumab administered intravenously every 3 weeks for the first 4 doses, followed by nivolumab alone every 4 weeks. Both treatments will last for approximately 2 years, but there is no time limit for treatment with encorafenib and binimetinib.

    The research team will closely monitor the patients’ health during regular clinic visits to see how they are responding to treatment. The main goal is to determine which treatment method is more effective in shrinking or eliminating melanoma tumors.

    • Nivolumab
    • Ipilimumab
    • Binimetinib
    • Encorafenib
    • Pembrolizumab
  • Clinical Trial for Finding the Best Dose of Clodronate for Painful Knee Osteoarthritis

    Howdy there, folks! This here clinical trial is aimin’ to find the best dose of a medicine called clodronate for treatin’ painful knee arthritis. It’s gonna be split into two parts.

    In the first part, they’ll have four groups of folks with knee arthritis. Three of them groups will get different doses of clodronate injected right into their knee once a week for four weeks. The fourth group will get a placebo, which is like a fake medicine. They’ll be keepin’ an eye on how safe and tolerable them different doses are.

    Once they figure out which dose works best without too many side effects, they’ll move on to the second part. In that part, they’ll have two groups – one gettin’ the best dose of clodronate from the first part, and the other gettin’ a placebo again. They’ll be checkin’ to see how effective and safe that best dose really is for helpin’ with knee arthritis pain.

    The main thing they’re lookin’ for is if the clodronate can reduce knee pain by at least 10 millimeters on a special pain scale called the Visual Analogue Scale, compared to the placebo group. They’ll be measurin’ that around 7 weeks into the study.

    So in a nutshell, they’re tryin’ to find the best and safest dose of clodronate for helpin’ folks with painful knee arthritis. It’s a two-part study, and they’ll be keepin’ a close eye on how well it works and how well it’s tolerated.

    • Clodronate
    • placebo
  • Study on combining two drugs – Fianlimab and Cemiplimab in patients with previously untreated melanoma

    This study examines two drugs, fianlimab and cemiplimab, given together for the treatment of melanoma. The main goal is to see how effective this drug combination is in treating melanoma compared with pembrolizumab, which is already approved for the treatment of melanoma in adults. The study will also look at whether there are any differences in the effects of these experimental drugs in adolescents and adults.

    Scientists also want to learn about other key issues: what side effects may occur from taking these experimental drugs, how much of the drugs enter the bloodstream over time, and whether the body produces antibodies to the drugs that could make them less effective or cause side effects. They will also check whether taking medications improves patients’ quality of life. Fianlimab and cemiplimab will be administered by intravenous infusion, and pembrolizumab will be administered by intravenous infusion.

    • placebo
    • Fianlimab
    • Cemiplimab
    • Pembrolizumab
  • Comparing Early Aggressive Treatment vs. Step-Up Approach in Childhood Arthritis

    This clinical trial, called STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS, aims to find the best way to treat children with certain types of arthritis, specifically oligoarthritis and polyarthritis. The study will compare two different treatment approaches:

    1. The conventional “step-up” approach, where treatment starts with a medication called methotrexate and then gets stronger if needed by adding other drugs like etanercept.

    2. The more aggressive “step-down” approach, where treatment starts with a combination of methotrexate and etanercept right away, and then the stronger medication may be stopped if the arthritis is well-controlled.

    The goal is to find out which approach works better at getting the arthritis under control quickly and keeping it controlled for a long period of time. Researchers think that aggressive treatment early on may be better for children because it can take advantage of the “window of opportunity” when the disease is new and may be easier to control. The study will last for 12 months and will look at how many children achieve clinical remission, which means having no signs or symptoms of active arthritis for at least 6 months. Steroid injections into affected joints may also be given as part of the treatment if needed.

    • Intra-articular corticosteroid injections
    • Methotrexate
    • Etanercept
  • Study of asciminib dosing and safety in pediatric patients with Chronic Myeloid Leukemia

    This study is designed to determine the appropriate dosing and assess the safety of the drug asciminib for children and teenagers who have a specific type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML-CP). These patients have previously been treated with at least one other medication known as a tyrosine kinase inhibitor (TKI). The study involves giving different doses of asciminib to see how well the drug works and how safe it is in young patients. The study will enroll participants into two age groups and will follow them over a five-year period to observe the effects of the treatment.

    • Asciminib
  • Sparsentan treatment study for children with Kidney Diseases

    This study involves children with kidney diseases that lead to high levels of protein in the urine. These diseases include Focal Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD), Immunoglobulin A Nephropathy (IgAN), Immunoglobulin A Vasculitis (IgAV), and Alport Syndrome (AS). The study will use a drug called Sparsentan, administered as an oral suspension or tablet.

    The goal is to determine if Sparsentan is safe and effective for these children. Participants will receive Sparsentan for 112 weeks, and their progress will be monitored to see if protein levels in their urine decrease and if their overall health improves. The study is open-label, meaning all participants will know they are receiving the drug.

    • Sparsentan
  • Exploring Delandistrogene Moxeparvovec for Duchenne Muscular Dystrophy

    The ENVISION trial is a research study focused on a new treatment for Duchenne Muscular Dystrophy (DMD), a condition that affects muscle strength. This trial is exploring a therapy called delandistrogene moxeparvovec, which is given through a vein. The purpose is to see if this treatment can improve muscle function by delivering a new gene to the body.

    This study is conducted on a large scale, involving many participants from different places, and is carefully controlled. Participants are randomly chosen to receive either the gene therapy or a placebo without knowing which one they are getting.

    The trial will go on for about 128 weeks (which is roughly 2 and a half years). An important part of the study is to see how the treatment might help with upper body movements, as these are essential for day-to-day tasks. Everyone in the study will eventually get a chance to receive the gene therapy, whether at the beginning or later on.

    • delandistrogene moxeparvovec

See more clinical trials in other cities in Italy:

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