Yerevan

This research aims to compare two formulations of Tamsulosin hydrochloride 0.4 mg prolonged-release tablets to evaluate their bioequivalence and safety in healthy adult male volunteers. The study focuses on assessing how similarly the test medication from Synthon Hispania SL, Spain and the reference drug Omnic Ocas4 by Astellas Pharma Europe B.V., the Netherlands behave in the body when taken as a single dose under fasting conditions. This is a Phase I study involving healthy men aged 18 to 45 years. Participants will receive a single dose of either the test or reference Tamsulosin tablet with 240 ml of water while fasting. The study design includes a randomized, open-label, two-treatment, two-period, two-sequence crossover format, meaning each participant will receive both medications in different periods to allow direct comparison. The tablets differ in formulation one is a prolonged-release tablet and the other is a prolonged-release film-coated tablet. During the study, participants will undergo clinical, laboratory, and instrumental examinations to confirm health status and monitor effects. The primary outcomes measured include the maximum concentration Cmax and area under the curve AUC over specific timeframes to assess drug absorption and exposure. Secondary outcomes include various pharmacokinetic parameters such as time to maximum concentration Tmax and half-life t 12. The study lasts approximately 72 hours per dosing period with safety and adherence closely monitored by the research team.

Age-related macular degeneration AMD is a common condition affecting many older adults, leading to a loss of light-sensitive cells in the retina called Geographic Atrophy GA. GA starts as a small spot away from the central vision area fovea and grows over time, causing severe vision loss when it reaches the fovea. This study is investigating whether GAL-101 eye drops can slow the growth of GA and help preserve vision in affected patients. Participants in this study will use eye drops containing GAL-101 or placebo daily. The treatment involves applying two drops of the assigned solution at 5-minute intervals each day. The study eye will be chosen based on vision and retinal health criteria, and only that eye will receive the eye drops. The treatment period lasts between 12 and 24 months, with visits scheduled at screening, baseline, 2 weeks by phone, and clinic visits at 1, 3, 6, 9, and 12 months, then every 3 months thereafter until the last patient completes 12 months of treatment. Participants will undergo several assessments including imaging and vision tests to track GA lesion size and photoreceptor degeneration. The study will measure how well GAL-101 slows GA growth over 48 to 96 weeks. Safety and efficacy will be monitored throughout the treatment period. The total participation time varies but includes regular clinic visits and phone contacts for up to two years or more depending on individual treatment duration.

Researchers are evaluating the treatment of anemia in patients with chronic kidney disease CKD who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 gdL and 12.0 gdL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 21 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods screening up to 28 days, treatment about 52 weeks, and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are conducting a nationwide registry in Armenia to observe and track systemic autoimmune and autoinflammatory diseases. These diseases involve abnormal immune system activity causing widespread inflammation and organ damage, often influenced by genetics and environmental factors. The study aims to better understand disease progression, which is usually measured by specific activity scores, and to gather detailed epidemiological and clinical data, as current knowledge in Armenia is limited. The study involves usual medical care for patients diagnosed with these systemic diseases, alongside collecting additional blood and stool samples for biobanking. Data collected include clinical exams, lab results, current treatments, and disease-specific activity scores reported by both patients and physicians. This observational registry will continue for about five years, assessing disease manifestations and evolution under treatment. Participants will be regularly evaluated through clinical and laboratory assessments, with data recorded on disease activity and progression. The study monitors systemic symptoms and uses disease-specific scores to track changes over time. Researchers will identify rare clinical forms and prognostic factors. The registry includes informed consent procedures and follows patients longitudinally to improve understanding of these complex diseases and their management.

Researchers are evaluating the safety and effectiveness of the drug balstilimab in adults with relapsed or refractory lymphomas, specifically classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma. This open-label phase 2 study focuses on patients who have no available standard therapy or have not responded to previous treatments. The study aims to gather important information about this treatment option under the guidance of the Immune Oncology Research Institute. Participants will receive balstilimab at a dose of 300 mg given intravenously every three weeks using an infusion pump. The treatment period can last up to 24 months or until certain criteria require stopping the drug or withdrawal from the study. The study includes a screening period of about 28 days before treatment and a follow-up period of up to 24 months after the last dose for those still living. During the study, participants will have regular assessments to monitor their response to treatment and safety. Researchers will measure outcomes like the objective response rate, duration of response, disease control, progression-free survival, and overall survival for up to 48 months. Safety will be closely monitored through tracking adverse events and laboratory tests. The total time a participant may be involved in the study can be approximately 49 months across all study periods.

Blastic Plasmacytoid Dendritic Cell Neoplasm BPDCN is a very rare blood cancer with no agreed-upon best treatment. Researchers are working internationally to gather detailed information on how BPDCN presents, how it is diagnosed, the treatments patients receive, and their outcomes. The study aims to build a large database to better understand the disease and to develop treatment recommendations based on collected data. This study is an international registry collecting information from multiple centers about patients diagnosed with BPDCN. It includes both retrospective and prospective data from patients worldwide. The data collected covers patient details, disease characteristics, treatment information, outcomes, causes of death, and the conclusion of data collection. Consent will be obtained from prospective patients, and quality control is managed by the Immune Oncology Research Institute. Participants will provide information through questionnaires completed by their treatment centers. Researchers will analyze overall survival, complete remission rates, duration of first remission, and event-free survival over five years. This observational study does not involve treatment but gathers and monitors detailed clinical data to improve understanding and guide future therapies for BPDCN.

Primary cardiac angiosarcomas are very aggressive tumors that develop in the hearts blood vessel lining, making up about 25%-30% of all primary heart cancers. This cancer mainly affects the right side of the heart and is known for rapid growth and damage to healthy heart tissue. The condition has a very low five-year survival rate of around 14%, and familial forms result in even shorter survival times. The goal of this international registry is to create a large database to better understand this rare and deadly disease by collecting detailed patient and treatment information from around the world. The registry collects clinical data including patient demographics, tumor details, treatments such as surgery, chemotherapy, immunotherapy, and radiation, as well as outcomes and side effects. It aims to analyze genetic, environmental, and lifestyle risk factors, evaluate treatment effectiveness, and develop guidelines for prevention, diagnosis, and management. Data quality and management are overseen by the Immune Oncology Research Institute. Participants provide information through questionnaires about their medical history, diagnosis, treatment, complications, and follow-up outcomes. Researchers will monitor survival and disease progression over time, focusing on measures such as 6-month overall survival and longer-term remission rates. The registry promotes collaboration among international healthcare providers and helps guide future clinical trials and treatment advances for cardiac angiosarcoma. The study is planned to run until May 2035.

Cancer is a major cause of illness and death among children, adolescents, and young adults, especially in low- and middle-income countries where timely diagnosis and treatment are often limited. This study follows young cancer patients in these settings to understand their treatment outcomes and challenges, aiming to improve access to care and results in resource-limited areas. It is a prospective, multicenter observational study that does not change or add experimental treatments. Participants include children, adolescents, and young adults diagnosed with cancer who receive routine care at participating hospitals in low- and middle-income countries. The study observes patients as a single cohort without assigning experimental treatments, with all medical care provided according to local standard practice. Researchers collect data on clinical outcomes, treatment failure, toxicity, and social factors affecting care. Participants will be followed from enrollment through 36 months of follow-up. Data will be gathered from medical records and questionnaires about access to care and social aspects affecting treatment. The study measures treatment failure and toxicity as primary outcomes and tracks secondary outcomes throughout the follow-up period. This observational study aims to provide insights into cancer care challenges and outcomes in low- and middle-income countries, with no changes to the usual care participants receive.

This research aims to assess cancer treatment outcomes in children, adolescents, and young adults aged 0 to 21 years living in low- and middle-income countries LMICs. It focuses especially on acute lymphoblastic leukemia ALL and lymphoblastic lymphoma LBL, which have poorer outcomes in these regions compared to high-income countries due to challenges like delayed diagnosis, limited access to therapies, and financial barriers. The study seeks to inform future efforts to improve care quality and reduce treatment failures through evidence-based strategies. The study involves a retrospective review of medical records from participating oncology centers in several LMICs, including Guatemala, Honduras, El Salvador, Armenia, and Tanzania. It includes patients with any cancer diagnosis, with particular attention to those diagnosed with ALL or LBL. Researchers will collect data on treatment failure incidence, therapy-related toxicities, and clinical outcomes over a three-year period following cancer diagnosis. No experimental treatments are administered the study uses existing medical records for analysis. Participants medical records will be reviewed to capture information on treatment failure, including relapse, progression, or abandonment, and therapy-related toxicities in the ALLLBL subgroup. Researchers will also analyze outcomes by cancer type, treatment regimen, age, and sociodemographic factors. The primary outcomes include incidence of treatment failure and toxicities within three years of diagnosis. This observational study will provide valuable data to guide improvements in cancer care for young patients in LMICs.