Ivanovo

Researchers are evaluating the pharmacokinetics, safety, and immune response of two drugs, RPH-030 and Vectibix4, in patients with metastatic colorectal cancer mCRC who have wild-type RAS genes. The study aims to show that these treatments are equivalent in how the body processes them and to compare their safety and immune effects. Additionally, the study will explore how effective these drugs are when used as first-line therapy combined with FOLFIRI chemotherapy. Participants will receive either RPH-030 or Vectibix4 intravenously at 6 mgkg every two weeks along with FOLFIRI chemotherapy, which includes irinotecan, calcium folinate, and fluorouracil. Treatment starts with FOLFIRI for 8 cycles, then continues with a modified de Gramont regimen. The study includes several periods a screening phase, a main period lasting up to 6 months, a continued therapy period up to 1 year where all patients receive RPH-030, and a treatment extension period lasting up to 2 years for patients with stable disease or response. Follow-up visits occur after treatment ends to monitor survival and disease status. Participants will undergo regular tumor assessments approximately every 6 to 8 weeks, hospitalizations for drug administration at specific visits, and blood sampling for pharmacokinetic and safety evaluations. Researchers will monitor drug levels over time, adverse events, immune reactions, and tumor responses. Follow-up includes imaging or phone calls to track overall survival and disease progression. The total study participation can last up to about 2 years with additional follow-up to ensure thorough monitoring of outcomes and safety.

Researchers are evaluating the safety and effectiveness of a new bevacizumab drug made by Mabscale, LLC, compared to Avastin, both combined with paclitaxel and carboplatin, for treating adults with advanced or inoperable non-squamous non-small cell lung cancer NSCLC. This phase III trial aims to show that the new bevacizumab works as well and is as safe as Avastin. The study also looks at how the drug is processed in the body. Participants are randomly assigned to one of two groups. One group receives the Mabscale bevacizumab with paclitaxel and carboplatin, and the other gets Avastin with the same chemotherapy drugs. Treatment cycles last about three weeks, with up to six cycles initially. After that, eligible patients continue with bevacizumab alone every three weeks. The study is double-blind, so neither patients nor researchers know who receives which bevacizumab. During the study, patients will undergo regular assessments including tumor measurements and blood tests. Researchers measure the tumor response at 18 weeks and track progression-free and overall survival at 18 and 42 weeks. The duration of response is also evaluated up to 48 weeks. Safety and side effects are closely monitored throughout the trial, which started in 2023 and will continue until 2027. Participants are followed closely to assess the treatments impact and safety.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are studying uncontrolled asthma in adults across Russia to better understand its characteristics and treatment patterns. This large-scale observational registry will include 9,000 patients from 70 outpatient centers in about 50 regions, focusing on those not receiving biologic therapy. The study aims to describe demographic and clinical features, capture complications and comorbidities, and evaluate routine therapies used in real practice. The study has an ambispective design with two main visits. At the first visit, physicians will collect baseline data from the past 52 weeks using medical records and patient interviews. The second visit, conducted 12 weeks later, will gather follow-up information on treatment changes and clinical outcomes. A subgroup of 500 patients using fixed-dose combination budesonidesalbutamol will have an additional third visit 12 weeks after the second to collect further data. Participants will undergo routine clinical assessments during 2 to 3 visits following standard practice. Researchers will examine demographic and clinical data, blood and sputum eosinophil counts, total IgE levels, asthma control status, lung function tests, exacerbation rates, and healthcare resource use. Safety monitoring aligns with routine care, and the study does not involve any experimental treatments or procedures. Total participation spans approximately 24 weeks for those in the extended follow-up group.

Researchers are evaluating the drug 4-MUST to understand its effectiveness, safety, and tolerability in treating patients with chronic cholecystitis and biliary dyskinesia. This study compares different doses of 4-MUST with a placebo to see how well the drug reduces upper abdominal pain and gastrointestinal symptoms. The trial is a phase 2, prospective, randomized, double-blind, placebo-controlled study designed to provide detailed insight into the drugs impact on these digestive conditions. Participants will be randomly assigned to one of four groups. One group receives 1 tablet of 4-MUST 128 mg plus 2 placebo tablets three times daily, another receives 2 tablets of 4-MUST 256 mg plus 1 placebo tablet three times daily, a third group takes 3 tablets of 4-MUST 384 mg three times daily, and the last group receives 3 placebo tablets three times daily. The treatment lasts for 29 days, with doses given three times a day, followed by assessment and monitoring. During the study, participants will undergo regular evaluations including pain measurement using a Visual Analog Scale VAS, gastrointestinal symptom rating via questionnaires, and quality of life assessments with the SF-36 questionnaire. Safety will be monitored through adverse event tracking, physical examinations, vital signs, laboratory tests, and electrocardiograms at multiple time points throughout the 29-day period and up to day 36. These thorough assessments aim to capture the drugs effects and tolerability over the course of treatment.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the effects and mechanisms of Mexidol both injectable solution and oral tablets in patients experiencing the hyperacute and acute stages of ischemic stroke. This pilot, randomized, multicenter, open-label study aims to understand how Mexidol impacts clinical outcomes and brain imaging results compared to Glycine tablets, with 100 stroke patients and 20 healthy volunteers enrolled. The study focuses on safety and efficacy during early stroke treatment phases. The trial includes two patient groups one receives Mexidol solution intravenously twice daily for 10 days followed by Mexidol FORTE tablets three times daily for 60 days, alongside standard stroke care. The other group receives Glycine sublingual tablets once daily for 5 days with standard care. Healthy volunteers do not receive treatment but provide baseline biomarker data. Treatments are given according to current clinical guidelines. Participants undergo multiple evaluations including brain imaging MRI and CT, blood tests for biomarkers and coagulation, and clinical assessments like the National Institutes of Health Stroke Scale and modified Rankin Scale. Assessments occur at baseline, day 11, and follow-ups up to day 90. Safety and tolerability are monitored throughout the study, which spans from initial treatment to three months post-treatment.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.

Researchers are evaluating the safety and effectiveness of adding REAMBERIN4 meglumin sodium succinate, a 1.5% infusion solution, to standard rehydration therapy for patients with diabetic ketoacidosis DKA. The study is a combined, two-stage, multicenter, randomized, double-blind phase IIIII trial designed to determine the best dose of REAMBERIN4 and compare it with a placebo to see if it helps resolve DKA more quickly and allows patients to leave the intensive care unit and hospital sooner. Participants will receive either REAMBERIN4 infusion at doses of 750 ml or 1500 ml per day or a placebo infusion of 0.9% normal saline at the same volume. The infusion will continue for up to 2 days or until the diabetic ketoacidosis resolves, whichever happens first. The study has two stages stage 1 tests two doses of the medication to find the optimal dose, and stage 2 recruits more patients to compare this optimal dose with placebo in equal groups. During the study, researchers will monitor the time from starting therapy to the resolution of diabetic ketoacidosis within 48 hours. Participants will undergo assessments to confirm their DKA status and safety monitoring throughout the infusion period. The study includes adults aged 18 to 75 years with confirmed DKA and diabetes. The total participation duration varies depending on the resolution of DKA, and safety follow-up will be conducted until hospital discharge.

Researchers are studying the effects of Ingavirin Forte capsules at different doses compared to the standard Ingavirin capsules and placebo in adults with influenza or other acute respiratory viral infections ARVIs. This Phase 2 trial aims to evaluate how well these treatments work, their safety, and how well patients tolerate them. Participants include adults aged 18 to 65 with confirmed influenza or ARVIs, showing significant symptoms and meeting specific clinical criteria. Participants are randomly assigned to one of five groups three groups receive Ingavirin Forte capsules at varying doses 90 mg plus either 5 mg, 10 mg, or 20 mg, one group receives standard Ingavirin 90 mg capsules, and one group receives a placebo. All treatments are taken as one capsule twice daily morning and evening for five consecutive days under double-blind conditions. During the 10-day study period, participants are monitored closely with visits on Days 3 and 6 to assess symptom severity, use of nasal sprays and pain medications, and viral elimination. Researchers measure the time until all symptoms resolve without additional medications and evaluate treatment effectiveness through clinical assessments and patient feedback. Safety and tolerability are also assessed throughout the trial, which may continue until the end of 2027.