Kemerovo

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.

This research aims to provide continued access to study treatments for participants with pulmonary hypertension who have completed previous clinical studies but have no other way to receive these treatments. It focuses on assessing the long-term safety of the study drugs macitentan, selexipag, and a fixed dose combination of macitentan and tadalafil. The study is designed for participants who benefited from these treatments during parent studies and have no alternative approved therapies available. Participants will continue receiving oral study drugs macitentan once daily with doses adjusted for children by weight, selexipag twice daily with dosing based on previous maintenance dose and body weight for children, or a fixed dose combination of macitentan and tadalafil once daily. Adults will have study visits every six months, while pediatric participants will have visits every three months. These visits will collect information on the treatments safety and effectiveness until the participant stops treatment, the drug becomes commercially available, or the study ends prematurely. During the study, participants will undergo regular assessments to monitor safety, including tracking treatment-emergent adverse events, serious adverse events, events leading to discontinuation, and deaths for up to 84 months. Visits will include collecting efficacy and safety data to ensure ongoing monitoring. The overall participation duration may extend for several years, allowing careful observation of long-term effects and safety of these treatments in people with pulmonary hypertension.

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 conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

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 pharmacokinetics, safety, and efficacy of doravirine DOR and a fixed-dose combination of doravirinelamivudinetenofovir disoproxil fumarate DOR3TCTDF in children aged 4 weeks to under 12 years who weigh less than 45 kg and are infected with human immunodeficiency virus type 1 HIV-1. The study includes participants who are either treatment-naive or have been virologically suppressed on stable combination antiretroviral therapy for at least 3 months without treatment failure. The goal is to understand how DOR behaves in the body and its safety when used with other antiretrovirals in this pediatric population. Participants receive DOR doses ranging from 7.2 mg to 100 mg based on weight, combined with two nucleosidenucleotide analog reverse transcriptase inhibitors NRTIs as per local guidelines, or a fixed-dose combination of DOR3TCTDF tailored to weight. Treatment lasts for 96 weeks, and those completing the Week 96 visit may join an extension study to continue receiving DOR for up to 224 additional weeks or until it becomes commercially available. Throughout the study, participants undergo intensive pharmacokinetic sampling to measure drug concentrations at specific time points, safety monitoring for adverse events, and evaluations of HIV-1 viral load and immune cell counts at various weeks up to Week 96. Researchers also assess adherence to the medication regimens and the palatability of the oral pellets or granules. The total duration of participation can extend up to several years, including the extension phase.

The trial investigates the safety and effectiveness of olokizumab compared to a placebo in adults with progressive fibrosing interstitial lung diseases ILD. This phase 23 study uses a double-blind, parallel-group adaptive design to better understand treatment impacts on lung function over time. Participants have progressive fibrosing ILD confirmed by imaging and lung function tests, with disease progression documented within the prior months or years. Participants will be randomly assigned to receive either subcutaneous injections of olokizumab 64 mg or placebo every four weeks during a 48-week treatment period. The study includes a screening period lasting four weeks, followed by a treatment period of 48 weeks, and then a follow-up period of 24 weeks with visits scheduled at 4, 12, and 24 weeks post-treatment. The total duration of participation is approximately 76 weeks. Throughout the study, patients will undergo lung function tests including forced vital capacity FVC and diffusion capacity for carbon monoxide DLCO, as well as imaging assessments to evaluate lung fibrosis. Researchers will monitor symptoms, lung function changes, and quality of life measures using dyspnea scores and health questionnaires. Safety will be closely observed during treatment and follow-up visits, with the main outcome focused on changes in FVC over 48 weeks.

Researchers are evaluating clinical outcomes for patients who begin inclisiran treatment within about two weeks after experiencing a heart attack STEMI or non-STEMI. This observational study focuses on patients in Russia and aims to understand the effects of inclisiran on lipid profiles, safety, atherosclerotic plaque status using carotid ultrasound, and the rates of hospitalizations and intensive follow-up over a 12-month period. Participants receive their first inclisiran injection approximately 14 days after their heart attack. The study observes changes in lipid levels at baseline, 3, 9, and 12 months, as well as plaque progression or regression over the year. Researchers also monitor adverse events, therapy discontinuation, hospital readmissions, emergency care visits, and the timing of dispensary observation. During the 12 months of participation, patients undergo lipid profile testing, carotid ultrasound scans, and safety evaluations at specified intervals. The main measure is the number of patients experiencing atherosclerotic cardiovascular disease events within a year after starting inclisiran in addition to their usual therapy. Secondary assessments include LDL cholesterol levels, plaque changes, adverse events, rehospitalizations, and use of emergency services, all tracked to evaluate the therapys impact and safety in real-world settings.

Researchers are evaluating how Lipoproteina Lpa levels vary among patients with Atherosclerotic Cardiovascular Disease ASCVD in Russia and investigating the relationship between elevated Lpa levels and cardiovascular disease risk. The study aims to better understand the distribution of Lpa and its connection to cardiovascular events in this population. The study includes several phases Phase I is a cross-sectional study measuring Lpa levels in ASCVD patients aged 18 and older. Phase II involves a non-interventional, prospective cohort study with these patients and their first-degree relatives, including parents and children with elevated Lpa levels. The study observes patients and relatives over time without altering their treatments. Participants will undergo assessments to measure Lpa levels and cardiovascular events at baseline and during follow-up visits up to 24 months. Researchers will collect clinical data, including disability status, cardiovascular events, hospitalizations, and lipid-lowering therapy usage. The study monitors the percentage of patients with elevated Lpa, occurrence of cardiovascular complications, and treatment outcomes to understand the impact of Lpa levels on ASCVD progression and related health events.

Researchers are evaluating the long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia HeFH or HoFH. This open-label, single-arm, multicenter extension study includes participants who have completed prior pediatric ORION studies ORION-16, ORION-13, ORION-20, or ORION-19. The trial aims to provide continued access to inclisiran treatment while monitoring safety outcomes over an extended period. Participants receive inclisiran injections, with dosing based on their previous study participation and weight. Those from ORION-16 or ORION-13 receive a 300 mg dose equivalent to 284 mg inclisiran in a 1.5 mL solution. Participants from ORION-19 and ORION-20 receive weight-based dosing. The study allows ongoing treatment with inclisiran to assess long-term effects and tolerability. During the study, participants are monitored for treatment-emergent adverse events and serious adverse events from day one through up to 1080 days. Researchers also measure changes in LDL cholesterol levels from the baseline of the prior studies to the end of this extension. The involvement includes regular safety assessments and evaluations to ensure participant well-being throughout the study duration, which may last nearly three years.