Kirov

Researchers are evaluating the safety and effectiveness of Radotinib in patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukemia (CP-CML) who have not responded well or cannot tolerate previous treatments with tyrosine kinase inhibitors (TKIs) including Imatinib. This Phase 3, multinational, multicenter, open-label study aims to enroll 173 participants to better understand Radotinib's impact on this condition. Participants will receive Radotinib capsules at a dose of 400 mg twice daily in a single treatment arm. Radotinib is provided as hard capsules containing 100 mg or 200 mg doses of the drug. Treatment will be administered continuously, and the study includes monitoring for safety and efficacy throughout the course. The study does not include a comparator group but follows participants closely for response to therapy. During the study, participants will be regularly evaluated to monitor their response, including measuring the major cytogenetic response at 6 months. Assessments will include laboratory tests to check organ function and disease status, as well as safety monitoring for side effects. The study requires participants to attend scheduled visits and comply with study procedures, including pregnancy testing for women of childbearing potential and contraception use. The overall participation duration and follow-up details are based on the study protocol.

Researchers are evaluating the effectiveness, side effects, and tolerability of vonicog alfa (recombinant von Willebrand factor, rVWF), with or without ADVATE, in treating and controlling nonsurgical bleeding events in children under 18 years old with severe hereditary von Willebrand disease (VWD). This Phase 3 study focuses on participants diagnosed with severe VWD and aims to understand how well these treatments work and how safe they are. Participants will receive vonicog alfa treatment over a period of 12 to 18 months. Their VWD will be managed by their doctors following usual clinical practices. The study involves using biological products including vonicog alfa, provided as a lyophilized powder and solvent for injection, and ADVATE, supplied as recombinant antihemophilic factor in vials. Treatment may be given with or without ADVATE as determined by the study design. During the study, participants will be monitored through clinic visits or telephone calls. Researchers will assess how well bleeding episodes are controlled within 24 hours after the last infusion of the study drug. Safety, tolerability, and treatment effectiveness will be regularly evaluated through ongoing follow-up. The total participation time spans the entire treatment period and monitoring visits to track outcomes and side effects.

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 effectiveness and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma. This open-label Phase 2 study focuses on individuals who have previously received at least two lines of therapy, including specific treatments like proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants must have measurable disease and documented progression according to established criteria. The study treatment involves administering BCD-248 subcutaneously. Patients eligible for the trial will receive this investigational drug during the study period. There are no comparator groups mentioned, and the treatment is given as a single intervention. This trial does not mention additional phases or extension periods. Participants will be monitored for their overall response rate to treatment up to 24 weeks, based on criteria set by the International Myeloma Working Group. Assessments include disease evaluations and safety monitoring. The study involves careful screening to ensure participants meet specific health and prior treatment requirements, with follow-up to track treatment outcomes and adverse events throughout the study duration.

Researchers are evaluating ANB-002, a gene therapy delivered by a single infusion, for its effectiveness, safety, and how it works in adult men with hemophilia B who have low FIX activity (2% or less) and no inhibitors. The study aims to show that ANB-002 is not less effective than the standard preventive treatment using coagulation factor IX (FIX). This is a phase 3, open-label, single-arm study focusing on this specific condition. Participants will first enter a lead-in period lasting at least six months, where they will receive standard FIX preventive treatment without any intervention from the study drug. After this period, they will receive one dose of ANB-002 at the start of the main study phase. This main phase will last 18 months following the infusion. After the main phase, participants will enter a follow-up period where they will be observed and evaluated for up to five years after receiving ANB-002. Throughout the study, researchers will track and compare the participants' annualized bleeding rates before and after receiving ANB-002. This includes monitoring during the lead-in period and from 12 to 18 months after treatment. Participants will also undergo safety checks and pharmacodynamic assessments during the main and follow-up periods to evaluate how the treatment affects their condition over time and to ensure ongoing safety.

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 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.

Researchers are evaluating the effectiveness and safety of Vespireit, prolonged-release tablets (15 mg), compared to Arlevert tablets (40 mg + 20 mg) in patients who have autonomic dysfunction syndrome along with functional vertigo. This Phase 4 trial focuses on adults aged 18 to 65 diagnosed with these conditions. The study addresses chronic functional vertigo symptoms measured by specific scoring systems and aims to provide new insights into treatment options for this population. Participants will be randomly assigned to receive either Vespireit, containing buspirone, or Arlevert, containing dimenhydrinate and cinnarizine. The study medication will be administered during an initial treatment phase lasting 28 days, with precise timing of visits and evaluations. Both drugs are oral tablets, and the comparison includes monitoring the response to therapy over this period. During the study, participants will undergo various assessments including measurement of vertigo scores to track changes from baseline. Safety and efficacy will be closely monitored through scheduled visits, with attention to any adverse events or therapy effectiveness. The primary outcome is the change in mean vertigo score from the start to the end of the initial treatment phase. Participants will be observed and evaluated throughout the treatment period with follow-up as needed, ensuring comprehensive data collection on treatment impact and safety.

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.