Malatya Merkez

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

Researchers are investigating the frequency of Neuronal Ceroid Lipofusinosis Type 2 CLN2 in children aged 2 to 6 years who have nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. This multicenter, non-drug screening study focuses on children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies, aiming to better understand the demographic and clinical features of those with possible CLN2 disease. Children first undergo assessments including recording demographic and medical history, seizure frequency, cognitive and language development evaluations, physical exams assessing muscle strength, gait, and coordination, as well as neurological evaluations using EEG and MRI scans. Those showing specific signs like speech disorder with seizures, movement problems, particular EEG responses, or MRI findings will have blood samples taken to measure Tripeptidyl Peptidase 1 enzyme levels. If enzyme activity is low, genetic testing is performed to investigate CLN2 disease. Participants are involved for up to one year during which various clinical, neurological, and imaging evaluations are done. Blood samples are collected for enzyme and genetic analyses. The main outcome measured is the frequency of CLN2 disease in this group. The study tracks each childs symptoms, neurological findings, and imaging results to better identify and understand CLN2 in children with these symptoms.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

This research aims to evaluate mezagitamab for adults with primary Immunoglobulin A nephropathy IgAN, a kidney disease caused by immune protein buildup leading to inflammation and potential kidney damage. The study will compare how mezagitamab affects protein levels in urine proteinuria against a placebo, focusing on safety, tolerability, and maintenance of kidney function over time. Participants will be randomly assigned to either receive mezagitamab or a placebo injection subcutaneously over approximately 22 weeks in the main group, with a 21 ratio favoring mezagitamab. An open-label group includes participants with specific proteinuria or kidney filtration levels, including those from a prior related study, all receiving mezagitamab in the same manner. After treatment, participants will be observed for about 1.5 years with regular check-ups. During the study, participants will attend multiple clinic visits for treatment and monitoring. Researchers will measure changes in proteinuria at Week 36 as the primary outcome, as well as kidney filtration rates over one and two years. Safety and long-term kidney function will be closely monitored throughout the 2-year participation period.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the combined use of vicadrostat and empagliflozin in adults with chronic heart failure who have a reduced left ventricular ejection fraction LVEF below 40%. Participants must have had chronic heart failure diagnosed at least three months before starting the study. The trial aims to find out if this combination helps people with symptomatic heart failure classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups, with an equal chance of receiving either vicadrostat plus empagliflozin tablets or placebo plus empagliflozin tablets. The study medicines are taken once daily for approximately six months up to about 3.5 years. During this time, participants may continue their usual heart failure treatments, excluding certain medications. The trial includes a double-blind design, meaning neither participants nor study staff know who receives the active drug or placebo. Throughout the study, participants visit the study site regularly, with the number of visits depending on how long they stay enrolled. Some visits may occur by phone. They answer questions about their well-being, and doctors monitor health status, record any heart failure worsening, hospitalizations, or deaths. The main outcome is the time until cardiovascular death, heart failure hospitalization, or urgent heart failure visit, which is compared between groups. Safety and side effects are also closely followed during the trial.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

This research aims to evaluate the safety, performance, and usability of several Occlutech accessory medical devices used in heart disease treatment. These devices include the Occlutech Delivery Set ODS, Occlutech Pistol Pusher OPP, Occlutech Occlusions-Pusher OOP, and Occlutech Sizing Balloon OSB. The study is international, multicenter, non-randomized, and non-invasive, focusing on catheter-based implantation procedures for cardiac implants. The study involves physicians experienced in cardiac catheterization using these accessories during implantation procedures. Investigators complete detailed surveys to assess each devices safety, including success of implantation, adverse events during or after the procedure, user harm, and any device deficiencies. The surveys also evaluate the performance, usability, and compatibility of these accessories with other devices. Subjects receive treatment following standard clinical routines and specific instructions for use. Participants who have undergone implantation with an Occlutech accessory and cardiac implant are included. Researchers monitor safety events and assess device performance and usability over a 6-month period. Data is collected via investigator questionnaires, focusing on implantation outcomes and any related complications. The total participation duration varies depending on individual follow-up but includes at least 6 months of monitoring for safety and performance.

This trial investigates the use of a medicinal product called Human Immunoglobulin for Intravenous Injection 5% to evaluate its safety and effectiveness in treating patients with primary Immune Thrombocytopenia ITP. This is a Phase III open-label study conducted at multiple centers, involving patients aged 18 to 65 years with confirmed chronic ITP and low platelet counts. The study is sponsored by Grand Shuyang Life Sciences Chengdu Co., Ltd. Participants will receive the investigational product, 5% IVIG, administered as a direct intravenous drip at a dose of 0.4 gkg daily for 5 consecutive days. The infusion rate starts at 1.0 mlmin and may increase if well tolerated, not exceeding 3.0 mlmin. The study consists of four periods including screening, baseline, treatment in a hospital setting, and follow-up visits on days 6, 7, 14, 21, 28, and 90 after the first dose. During approximately 104 days of participation, patients will attend nine scheduled visits for assessments including blood tests to monitor platelet counts and ITP bleeding scores. Researchers will measure treatment response within 7 days of infusion and track platelet counts and bleeding outcomes for up to 28 days. Safety and efficacy will be closely monitored throughout the trial, but the investigational product will only be provided during the study period and not after its completion.