Volgograd

Researchers are evaluating the pharmacokinetics, safety, and immune response of two treatments, RPH-030 and Vectibix®, in patients with metastatic colorectal cancer (mCRC) who have wild-type RAS genes. This phase I, multicenter, double-blind, randomized study aims to demonstrate that these treatments have equivalent pharmacokinetic properties when given as first-line therapy in combination with the chemotherapy regimen FOLFIRI. The study also includes a pilot evaluation of the efficacy of these treatments. Participants will be randomly assigned to receive either RPH-030 or Vectibix® intravenously at a dose of 6 mg/kg every two weeks alongside FOLFIRI chemotherapy. Treatment will continue for up to two years or until disease progression, unacceptable toxicity, or withdrawal of consent. The study is divided into several periods: a screening period lasting up to 27 days (extendable to 42 days if biopsy is needed), a 6-month main treatment period, a continued therapy period up to one year, a treatment extension period for responders lasting up to two years, and a follow-up period after treatment ends. During the study, patients will undergo regular tumor assessments approximately every 6 to 8 weeks depending on the study phase. Hospitalizations of at least 24 hours will occur at certain visits for drug administration. Researchers will monitor drug levels in the blood at multiple time points to understand treatment pharmacokinetics. Follow-up will include imaging tests, survival data collection, and safety monitoring until one year after treatment or until patient withdrawal or death. The goal is to assess treatment safety, immune response, effectiveness, and patient well-being throughout the study timeline.

Researchers are evaluating the safety and effectiveness of a new biosimilar drug called bevacizumab (made by Mabscale, LLC) compared to the existing drug Avastin4 in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has recurred or spread. This is a phase III randomized, double-blind trial designed to show that the new bevacizumab works as well and is as safe as Avastin4. The study also includes assessments of how the body processes the drug (pharmacokinetics). Participants will receive treatment with bevacizumab at 15 mg/kg or Avastin4, combined with chemotherapy drugs paclitaxel (175 mg/m2) and carboplatin (AUC 6). This combination is given as the first-line therapy for advanced NSCLC. The study is conducted across multiple centers and participants are randomly assigned to one of the two treatment groups without knowing which they receive. Throughout the study, participants will be monitored for their response to treatment, specifically measuring the Objective Response Rate at 18 weeks after starting therapy. Researchers will also assess safety and side effects. Various tests including tumor measurements, blood tests, and other evaluations will be done to ensure participants meet criteria and to track treatment effects. The total duration includes screening, treatment, and follow-up visits to monitor health and outcomes.

Researchers are evaluating the efficacy, safety, pharmacokinetics, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer (TNBC). This Phase 2 study focuses on patients who have received at least one prior systemic therapy and whose cancer has progressed or relapsed. The study aims to better understand how this combination treatment works in later lines of therapy for this aggressive breast cancer subtype. Participants will receive BCD-236 as an intravenous infusion along with chemotherapy, which will be chosen at the investigator's discretion. The study compares this combination treatment's effects and monitors participants over time. The primary outcome measured is the overall response rate at 24 weeks after starting treatment, assessing how well tumors respond to the therapy. Throughout the study, participants will undergo tumor assessments using RECIST 1.1 criteria to measure treatment response. Eligibility requires confirmation of AXL expression in tumor cells from fresh or archival tumor samples. Patients will be monitored for safety and disease progression, with evaluations including physical exams and performance status assessments. The study includes women aged 18 to 74 years with adequate health to participate and a life expectancy of at least four months.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are evaluating the effectiveness and safety of a non-immunogenic recombinant staphylokinase compared to a placebo in patients with intermediate high-risk pulmonary embolism (PE) who have normal blood pressure. This study focuses on patients who have right ventricular dysfunction and an increased risk of early death or hemodynamic collapse but are hemodynamically stable. The goal is to see if this treatment can improve outcomes without the risks seen in other thrombolytic therapies, such as hemorrhagic stroke. Participants receive either a single intravenous bolus of 15 mg of non-immunogenic recombinant staphylokinase or a placebo, both reconstituted in 15 ml of saline and given over 10-15 seconds. This single-dose treatment is compared to understand its safety and efficacy in reducing complications from intermediate high-risk PE. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial. Throughout the study, participants are monitored for outcomes including death, hemodynamic collapse, or recurrent PE within 30 days. Researchers assess heart function through imaging, blood tests such as troponin I levels, and clinical signs to evaluate treatment effects and safety. Patients must provide informed consent and agree to use reliable contraception during and shortly after the study. The total participation time includes initial diagnosis up to at least 30 days of follow-up to track key health events.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy (aromatase inhibitors with or without GnRH agonists) in patients with hormone receptor-positive, HER2-negative stage II-III breast cancer in Russia. The study includes both a prospective cohort receiving ribociclib plus hormone therapy and a retrospective cohort treated with hormone therapy alone. The goal is to assess treatment outcomes in different patient subgroups defined by tumor grade, lymph node involvement, and hormone therapy response. Participants in the prospective group receive ribociclib alongside aromatase inhibitors, with or without GnRH agonists, as part of their adjuvant therapy. The retrospective group includes patients treated with aromatase inhibitors alone during a specific period from July 2019 to July 2020. The study collects new data from the prospective group while also analyzing existing patient records from the retrospective group. Throughout the study, researchers monitor invasive breast cancer-free survival at 36, 48, and 60 months following treatment according to standardized criteria. Patient information is gathered from clinical records, including hormone therapy start dates and treatment responses. Safety and effectiveness are assessed by tracking outcomes over several years to better understand ribociclib's role in routine clinical practice for this type of breast cancer.

Researchers are evaluating the rate of chronic kidney disease (CKD) diagnosis in adults with arterial hypertension (AH) who have laboratory markers indicating possible CKD but no prior recorded CKD diagnosis. The study focuses on patients without diabetes mellitus or symptomatic chronic heart failure and aims to better understand CKD prevalence in this specific population in Russia. This multi-center, non-interventional, observational study includes both prospective and retrospective data analysis involving about 10,000 adult outpatients from approximately 50 outpatient sites across 20 regions of Russia. The study will not involve any new diagnostic or treatment procedures beyond routine clinical practice. Retrospective data will be collected from medical records to identify CKD markers measured within 12 months before study inclusion. Patients with adequate retrospective data may have CKD diagnosis confirmed based on two evaluations at least 3 months apart. Those without sufficient retrospective data will undergo laboratory testing during the prospective study period, which will last up to 18 months or until data from 10,000 patients are collected. Participants will be monitored and treated by cardiologists or internal medicine specialists during routine visits. Researchers will collect demographic and clinical information, including medical history and CKD markers, from both retrospective and prospective records. The main outcome is the rate of new CKD diagnoses over the 18-month follow-up. No additional interventions or procedures beyond usual care will be performed, and the study aims to support earlier CKD detection and improved clinical outcomes in patients with hypertension.

Researchers are studying the quality of primary health care for patients with arterial hypertension, focusing on how timely, accessible, and modern the medical care is. The study aims to evaluate how well doctors follow current clinical recommendations for diagnosis and treatment. It uses a cardiovascular disease registry system established at a federal clinical hospital in Russia to analyze patient data and improve care practices. The study collects medical data from outpatient records of patients aged 18 to 99 years with diagnosed arterial hypertension. This information is entered into an arterial hypertension registry, a computer program with remote access designed for online data collection from primary care. Doctors were trained to minimize errors, and patient data is transmitted anonymously through a secure channel after informed consent is obtained. Participants' medical examination and treatment data will be analyzed to observe trends in care quality from 2018 to 2021. The main outcome measured is the number of patients achieving blood pressure below 140/90 mm Hg. The registry allows ongoing monitoring and comparison with clinical guidelines to identify areas for improvement in managing arterial hypertension.

Researchers are studying the presence and types of other health conditions in patients having abdominal surgery to better understand and categorize the risk of complications after surgery. The goal is to identify which existing diseases independently predict such risks, as this knowledge is important for informed consent and planning preventive care. The study focuses on adults with certain physical health statuses undergoing planned operations, noting that while anesthesia risks have decreased, complications remain a significant concern worldwide. The study collects detailed information before surgery about patient age, gender, physical status (ASA classification), various chronic diseases like heart, lung, kidney, neurological disorders, and diabetes, as well as treatments the patient is receiving. It also records the type and severity of different abdominal surgeries and anesthesia methods used. Data is gathered uniformly from multiple centers and entered into an electronic database. The study includes patients operated on within defined days and monitors them until hospital discharge. Participants will have their health and surgical data collected and tracked, including cognitive function, respiratory and cardiac risk scales, and kidney and liver function. Postoperative complications occurring within 7 days of surgery are the main outcomes measured. The study plans to enroll a large number of patients to develop reliable risk prediction models, with ongoing data analysis using statistical methods to identify significant predictors. Results will be validated with additional patient groups to improve accuracy and clinical usefulness.

Researchers are investigating the effectiveness and safety of using recombinant non-immunogenic staphylokinase (Fortelyzin4) administered directly into the artery at the site of the clot in patients with acute limb ischemia (ALI) compared to traditional surgery. This phase 3 clinical trial focuses on patients with ALI of degrees I to II b, aiming to find better treatment options since intravenous thrombolysis is ineffective for this condition. Previous studies with Fortelyzin4 in heart attack and stroke patients showed promising results with fewer bleeding complications and no immune reactions. The study compares two treatment approaches: intra-arterial thrombolysis with Fortelyzin4, a fibrin-selective clot-busting drug given as a lyophilisate solution, and surgical methods including endovascular intervention, open surgery, or bypass surgery following national guidelines. Patients will be randomly assigned to either receive Fortelyzin4 directly at the clot or undergo one of the surgical procedures. The trial is open-label and conducted at multiple centers. Participants will be monitored to see if they avoid amputations within 30 days after treatment. Researchers will assess safety and effectiveness through clinical evaluations and track adverse events. Informed consent and contraceptive use during and after the study are required for participants. The study includes follow-up to measure outcomes and ensure participant safety over the trial period.