Tver

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.

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

Researchers are evaluating the safety and effectiveness of Indinol Forto 200 mg capsules compared to Visanne 2 mg tablets for treating endometriosis in females aged 18 to 45. This phase 3, open-label, randomized study is designed to test whether Indinol Forto is not less effective than Visanne. Participants have endometriosis confirmed by surgery within the past 60 months and experience moderate pelvic pain. Participants will be randomly assigned to one of two groups one group will take Indinol Forto capsules twice daily, and the other group will take Visanne tablets once daily, both for 24 weeks. Before treatment starts, there is a screening menstrual cycle to confirm eligibility. After completing the 24-week treatment period, participants will be observed for an additional month during a post-treatment follow-up. During the study, participants will daily record pelvic pain using a Visual Analog Scale, noting both cyclic and non-cyclic pain and vaginal bleeding intensity. Researchers will assess changes in average daily pelvic pain after 24 weeks of treatment compared to the screening period. Additional evaluations include quality of life, endometriosis symptoms, menstruation patterns, and lesion size. Safety and symptom changes will be monitored throughout the study and post-treatment period.

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 safety and effectiveness of a single bolus dose of non-immunogenic recombinant staphylokinase compared to a placebo in adults with intermediate high-risk pulmonary embolism PE who have stable blood pressure. This phase 3 trial addresses the need for safer thrombolytic treatments in patients who are at risk but do not have shock or low blood pressure, as previous thrombolytics had risks like hemorrhagic stroke. The study aims to improve outcomes while minimizing adverse effects in this patient group. Participants receive either a quick intravenous injection of non-immunogenic recombinant staphylokinase or a matching placebo. The staphylokinase dose is 15 mg given as a single bolus over 10-15 seconds regardless of body weight. The placebo group receives a similar injection with saline solution. This treatment period is followed by monitoring to compare the effects and safety between the two groups. During the study, participants will be assessed for clinical outcomes including death, hemodynamic collapse, and recurrent pulmonary embolism within 30 days. Additional measures include heart function and lung pressure evaluations within 24 hours and 30 days, along with monitoring for bleeding events and other adverse effects. The trial lasts for 30 days after treatment with ongoing safety checks, and participant consent and adherence to contraceptive use are required throughout the study period.

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.

This research aims to study the safety and effectiveness of a drug called non-immunogenic staphylokinase in patients with massive pulmonary embolism, a serious condition involving blood clots in the lungs. The study builds on previous trials that found this drug to be as effective as alteplase with fewer major bleeding events, making it a promising emergency treatment option. The study is observational and focuses on patients receiving this drug in routine clinical practice. Participants receive a single intravenous bolus dose of 15 mg non-immunogenic staphylokinase Fortelyzin4 regardless of body weight. This drug is easy to administer quickly in emergency situations and is used for treating massive pulmonary embolism since 2024. The study collects information on patients treated with this drug to assess outcomes in a real-world setting. During the study, participants are monitored for outcomes such as all-cause mortality at 7 and 30 days after drug administration, hemodynamic collapse, recurrent pulmonary embolism, and pulmonary artery systolic pressure changes. Safety is closely observed, especially for bleeding events. The study runs from June 2025 to December 2027, with ongoing evaluation of participants following treatment in routine care.

Researchers are investigating the use of a recombinant non-immunogenic staphylokinase Fortelyzin in patients who have experienced an acute ischemic stroke between 4.5 and 24 hours after symptom onset. This phase III, multicenter, double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety of this drug in restoring blood flow in patients with large vessel occlusion stroke who arrive outside the standard 4.5-hour treatment window. The study focuses on patients with salvageable brain tissue identified by advanced imaging techniques. Participants will be randomly assigned to receive either a single intravenous bolus injection of 10 mg non-immunogenic staphylokinase or a placebo administered rapidly within 5 to 10 seconds regardless of body weight. The trial excludes patients planned for direct thrombectomy. Following treatment, patients will be monitored for up to 90 days to assess outcomes. The trial evaluates functional recovery and reperfusion improvements compared to placebo. Throughout the study, participants will undergo imaging assessments such as CT or MRI perfusion scans to confirm eligibility and monitor brain tissue status. Researchers will evaluate functional outcomes using established stroke scales over 90 days, including the modified Rankin Scale and NIH Stroke Scale. Safety, mortality, and reperfusion rates will also be tracked. Participants will have follow-up visits and assessments designed to measure recovery and treatment impact over the trial period.