Yerevan

Researchers are evaluating the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg prolonged-release tablets made by Synthon Hispania SL compared to the reference drug Omnic Ocas®, which contains the same dose of Tamsulosin hydrochloride in prolonged-release film-coated tablets. This Phase I study is conducted in healthy adult male volunteers aged 18 to 45 years under fasting conditions to compare these two formulations. The study uses a randomized, open-label, single-dose, two-treatment, two-period, two-sequence crossover design. Participants receive either the test medication or the reference drug, both containing 0.4 mg of Tamsulosin hydrochloride, with a washout period between treatments. The tablets are administered under fasting conditions to evaluate how the body absorbs and processes each formulation. During the study, volunteers undergo clinical, laboratory, and instrumental assessments to confirm health status and monitor safety. Blood samples are collected to measure pharmacokinetic parameters such as maximum concentration (Cmax) and area under the curve (AUC) over 72 hours and beyond. Participants are monitored for adverse events, and adherence to study restrictions such as abstinence or use of double-barrier contraception is ensured. The total study duration includes screening, treatment periods, and follow-up to assess drug bioequivalence and safety.

Age-related macular degeneration (AMD) is a common condition affecting many older adults, leading to Geographic Atrophy (GA) in the retina where light-sensitive cells are lost. This damage begins away from the central vision area called the fovea, but as GA grows and reaches the fovea, sharp vision is greatly reduced. The eDREAM study aims to evaluate if GAL-101 eye drops can slow the growth of GA and prevent it from affecting central vision. This is a Phase 2, double-masked, randomized study comparing GAL-101 to placebo drops in people with non-foveal GA caused by non-neovascular AMD. Participants will be randomly assigned to receive either GAL-101 or placebo eye drops. During clinic visits, patients will receive three drops spaced 5 minutes apart under supervision, and at home they will administer two drops once daily at 5-minute intervals. The treatment period lasts 12 to 24 months, with all patients participating for at least 12 months. Study visits include screening, baseline, and regular follow-ups at 1, 3, 6, 9, and 12 months, then every 3 months until the last patient completes 12 months of treatment. Participants will undergo detailed eye imaging and vision tests to monitor the size and progression of GA lesions and their vision quality. Safety and efficacy will be assessed through these visits and phone calls. The main outcome is how well GAL-101 slows the growth of GA lesions from baseline to up to 96 weeks. Patients' ability to administer the drops and adhere to the schedule will also be supported and monitored throughout the study.

Researchers are evaluating the effects of TX000045 in patients with pulmonary hypertension caused by heart failure with preserved ejection fraction (PH-HFpEF). This Phase 2, double-blind, randomized, placebo-controlled proof-of-concept study aims to assess two dosing regimens of TX000045 over a 24-week treatment period to understand its impact on pulmonary vascular resistance and safety profile. Participants will be randomly assigned to one of three groups: a placebo group receiving subcutaneous injections every two weeks, a group receiving Dose A of TX000045 subcutaneously every two weeks, and a group receiving Dose B of TX000045 subcutaneously every four weeks alternating with placebo every two weeks. The treatment period lasts for 24 weeks. Throughout the study, participants will undergo assessments including pulmonary vascular resistance measurements, physical examinations, laboratory tests, and monitoring for adverse events from baseline up to 30 weeks after the first dose. Safety evaluations focus on treatment-related side effects and changes in lab values. The study plans to enroll about 180 participants between 18 and 83 years old with specific heart and lung function criteria.

Researchers are evaluating the pharmacokinetics, efficacy, safety, and immune response of MB12, a proposed pembrolizumab biosimilar, compared to Keytruda® in patients with advanced stage IV non-squamous non-small cell lung cancer (NSCLC). This Phase 3, randomized, double-blind study involves patients who have not received prior systemic treatment for metastatic NSCLC and includes a range of international centers. The trial focuses on patients without EGFR activating mutations or ALK translocations and measures outcomes up to 24 weeks. Participants receive either MB12, EU-sourced Keytruda®, or US-sourced Keytruda®, each given as a 200 mg intravenous infusion every 3 weeks on Day 1. These immunotherapy drugs are combined with chemotherapy agents pemetrexed (500 mg/m2 IV every 3 weeks on Day 1) and either carboplatin (area under the curve 5 IV every 3 weeks on Day 1 for 4 cycles) or cisplatin (75 mg/m2 IV every 3 weeks on Day 1 for 4 cycles). The combination treatment is administered as a first-line therapy for metastatic NSCLC. During the study, patients are monitored for drug levels in the blood, treatment effectiveness, safety, and immune response. Regular assessments include imaging to measure tumor lesions using RECIST 1.1 criteria and evaluations of overall health and organ functions. The study aims to confirm that MB12 is similar to Keytruda® in how it is processed by the body and in its treatment results. Participants are followed for at least 24 weeks to collect data on these outcomes.

Researchers are evaluating ivosidenib in adults with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA) to confirm its safety, effectiveness, and impact on quality of life. This Phase 3b open-label study includes patients who have documented IDH1 gene mutations and have tried at least one prior systemic therapy for CCA. The study aims to consolidate data on ivosidenib use in this patient group, focusing on adverse events, quality of life, and treatment outcomes. All participants will receive ivosidenib tablets orally once daily at a dose of 500 mg for 28-day cycles. Treatment continues as long as clinical benefit is observed and consent is maintained. The study includes a screening visit, a study visit on day 1 of each cycle, a withdrawal visit within 42 days after stopping treatment, and follow-up visits every 6 months for up to 18 months after treatment ends. Additional study visits will be added for each completed cycle. Participants will undergo various assessments at study visits, including electrocardiograms (ECG), physical exams, tumor assessments according to local practice, and blood and urine tests. Researchers will monitor safety by tracking adverse events, serious adverse events, ECG changes, lab abnormalities, vital signs, and performance status through the treatment and follow-up periods. If ivosidenib becomes available as a prescription outside the study, patients will be withdrawn from treatment but followed for overall survival data.

Researchers are establishing a nationwide Armenian registry to study systemic autoimmune and autoinflammatory diseases, which involve abnormal immune responses causing inflammation and organ damage. These diseases affect patients' quality of life and are influenced by genetic and environmental factors. The study aims to collect detailed information on these diseases, which have been underexplored due to their complexity and lack of specific treatments, while recent advances in targeted biological therapies have improved patient outcomes. Participants will receive usual medical care while additional blood and stool samples are collected for biobanking. Data collected will include clinical examinations, laboratory results, current medications, and disease-specific activity scores along with subjective assessments of disease activity from both patients and physicians. This longitudinal, multicenter registry will monitor various diseases such as Behcet disease, vasculitis, arthritis, angioedema, celiac disease, and others. During the study, researchers will track disease manifestations and their progression using specific activity scores over an average of five years. This ongoing monitoring will help understand disease evolution and treatment effects. Participants will provide informed consent and be followed regularly to contribute data for this comprehensive registry, which seeks to improve knowledge and management of these systemic diseases in Armenia.

Researchers are evaluating the safety and effectiveness of balstilimab, an anti-PD-(L)1 monoclonal antibody, in adults with relapsed or refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma. This is a phase 2, open-label study including participants whose lymphoma has returned or did not respond to prior treatment, and who have no standard therapy options or have failed previous treatments. Participants will receive balstilimab 300 mg through an intravenous infusion every 3 weeks, administered using an infusion pump within about 30 minutes. The study includes three periods: a screening period lasting about 28 days, a treatment period lasting up to 24 months or until stopping criteria are met, and a follow-up period lasting up to 24 months after the last dose for participants who are still alive. Recruitment is planned for 2 years, with treatment and follow-up also spanning 2 years each. During the study, participants will undergo regular assessments to monitor their response to treatment, including measuring the Objective Response Rate from the first dose up to 27 months. Safety and organ function will be checked through laboratory tests and other evaluations. Participants will be followed for up to 49 months in total to observe treatment outcomes and any side effects.

Researchers are evaluating the safety and effectiveness of combining two immunotherapy drugs, botensilimab and balstilimab, as a first treatment option for people with metastatic non-small cell lung cancer (NSCLC). This is a phase II, single-arm, open-label study enrolling participants with confirmed metastatic NSCLC who do not have targetable EGFR mutations or ALK rearrangements. The study excludes individuals with untreated brain metastases or limited metastatic disease without targetable lesions. Participants will receive the combination of botensilimab, an antibody targeting CTLA-4, and balstilimab, an antibody targeting PD-1. The study includes three periods: a screening period lasting about 28 days, a treatment period of up to 24 months or until stopping criteria are met, and a follow-up period of up to 24 months after the last dose for participants who are still alive. The recruitment phase is planned to last two years. During the study, participants will undergo various assessments including evaluations of tumor response according to standard guidelines, laboratory tests to monitor organ function and blood counts, and safety monitoring. The main outcome measured is progression-free survival over 12 months from the first dose. Participants must meet specific health and laboratory criteria before starting treatment and will be followed for up to approximately 49 months in total.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare blood cancer recognized as a distinct disease since 2008. There is currently no agreed-upon best treatment for BPDCN, and because the disease is so uncommon, international collaboration is needed to collect detailed information on how BPDCN presents, is diagnosed, and responds to different treatments. The study aims to build a large global database of BPDCN patients, examine disease characteristics and outcomes across various treatments, identify factors that affect prognosis, and develop treatment recommendations based on collected data. This study is an international registry collecting both past and new patient data from multiple centers worldwide. Participating centers gather detailed patient information through questionnaires, including patient and disease characteristics, treatment details, outcomes, causes of death, and the timing of data collection. The registry does not involve any experimental treatments but focuses on collecting comprehensive clinical data to better understand BPDCN. Participants provide informed consent if enrolled prospectively, and data quality is managed by the Immune Oncology Research Institute. Researchers will analyze overall survival over five years as a key outcome. This registry supports ongoing monitoring and data collection to improve knowledge about BPDCN and guide future treatment strategies.

Primary cardiac angiosarcomas (PCA) are aggressive malignant heart tumors arising from the endothelial cells lining the heart's blood vessels. They represent about 25%-30% of all primary cardiac malignancies and are the most fatal type of heart cancer, often affecting the right atrium and other heart chambers. This international registry aims to gather extensive data to better understand PCA's clinical features, risk factors, and treatment outcomes across diverse populations. The registry collects detailed clinical information such as patient demographics, medical history, tumor characteristics, and treatment details including surgery, chemotherapy, immunotherapy, and radiation. It will include patients diagnosed from January 2015 to January 2035 who have undergone any form of treatment. The registry also supports collaboration among researchers and healthcare providers worldwide to improve knowledge and develop best practices. Participants provide data through questionnaires covering diagnosis, treatments, complications, and follow-up outcomes. Quality control and data management are handled by the Immune Oncology Research Institute. The main outcome measured is overall survival at 6 months. The registry encourages ongoing follow-up assessments to track patient progress and treatment effectiveness over time.