Novosibirsk

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 evaluate the safety and early effects of vitamin K2 menaquinone-7, MK-7 supplementation in adults aged 40 to 75 years with low bone mineral density, including osteopenia or osteoporosis. The study focuses on individuals carrying a specific unfavorable variant in the vitamin D receptor VDR gene, comparing them to those without this gene variant. The goal is to see if MK-7 supplementation improves bone health and related markers more in the variant group, who may have a reduced response to vitamin D. Participants will receive vitamin K2 menaquinone-7 at doses of 100 to 200 micrograms per day along with vitamin D3 at 800 to 1000 IU per day for a period of 6 to 9 months. The study has two groups one with homozygous carriers of the VDR variant and one control group without the variant. Both groups will follow the same supplementation regimen to compare outcomes related to bone health. During the study, participants will be monitored for changes in bone mineral density over 9 months, along with serum osteocalcin levels, bone turnover markers, vitamin D levels, and quality of life measures. Safety and tolerability will be assessed by recording any treatment-related adverse events. Participants will maintain stable diets and exercise routines, and genotyping will confirm their group assignment. Total participation will last up to 9 months with regular assessments.

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 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 research aims to assess the physical impact of Multiple Sclerosis MS from the participants perspective. It also provides participants continued access to the medication ocrelizumab while evaluating its safety and tolerability. The study is an open-label extension phase 3 trial sponsored by Hoffmann-La Roche, focusing on patients previously enrolled in related studies who currently lack local access to ocrelizumab treatment. Participants will receive ocrelizumab either as a 600 mg intravenous infusion or a 920 mg subcutaneous injection, following the dosing schedule established in their prior parent study. Treatment will continue until local access to the drug becomes available, if safety concerns arise, if the participant withdraws consent, or in the event of death. During the study, participants will be monitored for changes in physical functioning using patient-reported outcome measures over up to five years. Researchers will also track the number of participants receiving ocrelizumab and monitor adverse events, including serious or special interest events that may lead to discontinuation. Safety and tolerability assessments will continue throughout the study duration, which may last up to five years.

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 evaluating the safety, effectiveness, and pharmacodynamics of a single dose of ANB-002, a gene therapy, in adult men with hemophilia B who have low factor IX FIX activity and no FIX inhibitor. The study aims to show that ANB-002 is not less effective than standard preventive treatment using FIX concentrates. This is an open-label, phase 3 trial sponsored by Biocad. Participants first undergo a non-interventional lead-in period lasting at least six months during which they receive standard FIX preventive treatment. After this, they enter the main interventional period where they receive a single infusion of ANB-002. This main period lasts 18 months, followed by a follow-up period of up to five years after the ANB-002 infusion. During the study, researchers will monitor participants bleeding rates before and after treatment, FIX activity levels, and FIX concentrate use. They will also assess the proportion of subjects not needing FIX prevention, and track various bleeding events including spontaneous bleedings and hemarthrosis. Safety and treatment effects will be evaluated over the long-term follow-up, with study participation lasting up to five years after treatment.

Researchers are investigating the link between persistent Helicobacter pylori infection and the severity of insulin resistance in 100 patients diagnosed with metabolic syndrome. This retrospective cohort study aims to clarify how chronic H. pylori-related inflammation may worsen metabolic factors related to insulin resistance, a key component of metabolic syndrome that contributes to type 2 diabetes, liver disease, and cardiovascular problems. Participants are divided into two groups those with metabolic syndrome who have persistent H. pylori infection and those without the infection. The study evaluates metabolic markers, including insulin resistance measured by the HOMA-IR index, along with inflammatory markers like C-reactive protein CRP and various metabolic parameters such as body mass index, waist circumference, fasting glucose, and cholesterol levels. Measurements are taken within two days of study inclusion. During participation, patients undergo fasting blood tests, breath tests, stool antigen tests, and possibly endoscopy with biopsy to confirm infection status and metabolic parameters. Researchers will compare insulin resistance levels and correlations with inflammation and metabolic markers between infected and non-infected groups. The study is observational and does not include treatment interventions, with participation lasting through the data collection period shortly after inclusion.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.

Researchers are studying patients with atherosclerotic carotid stenosis, including both symptomatic patients with stenosis over 50% and asymptomatic patients with stenosis 80% or greater. This trial compares early neurological outcomes using two different embolic protection devices combined with the CGuard microNet covered stent. The purpose is to evaluate whether distal or proximal embolic protection device placement offers better results, expanding on previous findings that showed CGuard stent implantation had advantages over classical stents using distal protection. Participants will undergo carotid artery stenting with one of two devices the Emboshield NAV6 distal embolic protection system plus the CGuard stent, or the Mo.Ma proximal cerebral protection device plus the CGuard stent. The study groups are randomized and unblinded, and both devices aim to reduce embolic events during the stenting procedure. The trial began in November 2021 and will continue until January 2027. During the study, participants will receive neurological assessments and brain imaging to detect ischemic lesions within 24 to 48 hours after the procedure. The primary outcome is the determination of these ischemic lesions, while secondary outcomes include monitoring major adverse cardiac and cerebrovascular events during and shortly after the procedure. Participants must consent to follow-up visits and procedures as part of the trial involvement.