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This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

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 effect of AZD0780 tablets on lowering low-density lipoprotein cholesterol (LDL-C) compared with placebo tablets, both given alongside rosuvastatin tablets, in adult Russian participants with dyslipidaemia. AZD0780 is a small molecule aimed at reducing LDL-C in the blood. This Phase II, randomized, double-blind, placebo-controlled study includes adults aged 18 or older with specific LDL-C levels and a history or risk of atherosclerotic cardiovascular disease (ASCVD). Participants will first go through a screening period of up to 14 days, followed by a 28-day run-in period taking rosuvastatin tablets. Then, they will be randomly assigned to receive either AZD0780 or placebo tablets once daily for 12 weeks, continuing rosuvastatin during this time. After treatment, there will be a 10-day safety follow-up. The study will be conducted at approximately 11 centers in Russia and plans to enroll about 76 participants. During the study, participants will undergo various assessments including fasting LDL-C measurements at baseline and after 12 weeks to evaluate the relative change. Safety and tolerability will also be monitored throughout. The total study duration for each participant is up to 136 days, including all periods. Researchers will use these data to understand the effects and safety of AZD0780 when combined with rosuvastatin.

Researchers are evaluating the effects of a combined treatment of zibotentan and dapagliflozin compared to dapagliflozin alone in adults with chronic kidney disease (CKD) who have high levels of protein in their urine. This Phase II, multicenter, randomized, double-blind study aims to assess the efficacy, safety, and tolerability of this combination on top of standard care, including participants with or without type 2 diabetes mellitus (T2DM). The study will provide important clinical data for potential approval of this combination treatment in the Eurasian Economic Union. Participants may undergo a 28-day run-in period with dapagliflozin if they are not already using SGLT2 inhibitors at screening. Following this, they will enter a 12-week double-blind treatment period where they receive either the fixed-dose combination of zibotentan/dapagliflozin or dapagliflozin monotherapy once daily. After completing the treatment phase, all participants will receive open-label dapagliflozin alone during a 4-week safety follow-up period. Throughout the study, researchers will monitor changes in urinary albumin to creatinine ratio (UACR) from baseline at week 12 to evaluate treatment effects. Participants will be assessed regularly for safety, tolerability, and efficacy, with clinical evaluations including laboratory tests and monitoring of adverse events. The total study participation includes the run-in period, 12-week treatment, and a 4-week safety follow-up, ensuring comprehensive observation of treatment impact and participant health.

Researchers are evaluating the physical impact of multiple sclerosis (MS) from the participant's perspective while providing continued access to the drug ocrelizumab. This Phase 3 extension study focuses on assessing the safety and tolerability of ocrelizumab, a treatment for MS, at approved doses. The study includes participants who were already receiving ocrelizumab in previous Genentech and/or F. Hoffmann-La Roche Ltd sponsored studies and do not have local access to this treatment through other means. Participants will receive ocrelizumab either by intravenous (IV) infusion at 600 milligrams or by subcutaneous (SC) injection at 920 milligrams, following the dosing schedule from their previous parent study. Treatment will begin no earlier than five months after their last dose in the parent study. This open-label, multicenter extension provides ongoing access to ocrelizumab for up to five years. Throughout the study, participants will be monitored for changes in their physical functioning using the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis (PROMISnq PFMS-15a). Researchers will also track the number of participants receiving ocrelizumab during the study and assess safety and tolerability over the long term. Monitoring includes regular evaluations to ensure participant well-being during the extended treatment period.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Researchers are evaluating the immunogenicity, reactogenicity, and safety of the drug GNG-DE compared to a reference drug for preventing meningococcal infections caused by serogroups A, C, W, and Y. This Phase 3 study includes participants aged 3 to 55 years and aims to assess how well GNG-DE stimulates an immune response and its safety profile versus the reference vaccine. Participants are divided into two groups: one group of 40 participants will receive a 0.5 mL dose of GNG-DE administered intramuscularly into the deltoid muscle, while the other group of 40 will receive a 0.5 mL dose of the Menactra® vaccine via the same method. Both treatments are given as single doses during the study. During the study, participants will be monitored for immune response by measuring primary immunogenicity parameters around Day 29. Safety and reactogenicity will also be assessed. Participants must attend scheduled visits, complete observation diaries, and comply with study requirements. The study includes screening tests such as SARS-CoV-2 antigen and pregnancy tests when applicable, and participants will be observed for any adverse reactions to the vaccines.

Researchers are conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection (ARVI) symptoms within 24 hours of onset. The trial aims to evaluate the efficacy and safety of Raphamin compared to a placebo in treating ARVI. Enrollment will begin with children aged 6 to 12 years, followed by an interim analysis to decide whether to include younger children aged 3 to 5 years. Patients will be outpatients of either gender during seasonal ARVI incidence. Participants will be randomly assigned to receive either Raphamin tablets or placebo tablets for 5 days. Treatment groups follow the same dosage regimen. Before starting therapy, nasopharyngeal swabs will confirm viral infection through PCR testing. Throughout the trial, an electronic patient diary will be used to record temperature, symptoms, antipyretic use, and any worsening condition. The study includes screening, randomization, treatment, and follow-up periods lasting a total of 14 days. During the study, patients will attend three visits on days 1, 5, and 7, either at a health center or home, plus a phone visit on day 14. At visits, physicians will assess symptom severity, perform examinations, monitor diary completion, and conduct lab tests. The main outcome measured is the time needed for ARVI symptoms to resolve within 14 days. Safety and compliance will be closely monitored, and symptomatic or concomitant therapies are allowed except for prohibited drugs.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.