Brovary, Ukraine
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.
Phase
3Span
295 weeksSponsor
AstraZenecaSofia
Recruiting
Integrated Approach in Frail Older People with Atrial Fibrillation
Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.
Phase
N/ASpan
95 weeksSponsor
Heart Care FoundationSofia
Recruiting
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
Phase
1Span
40 weeksSponsor
Chiesi Farmaceutici S.p.A.Sofia
Recruiting
Healthy Volunteers
Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)
TACTI-004 is a double-blinded, randomized phase 3 trial in patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving eftilagimod alfa (major histocompatibility complex (MHC) class II agonist) in combination with pembrolizumab (programmed cell death protein 1 (PD-1) antagonist) and chemotherapy. The proposed clinical trial aims to compare the efficacy and to demonstrate the superiority of efti combined with standard of care (SoC, pembrolizumab and histology-based chemotherapy) compared to placebo combined with SoC in programmed death-ligand 1 (PD-L1) unselected population as assessed by: - Overall survival [OS] - Progression-free survival [PFS] per RECIST 1.1 The trial is planned to be conducted in countries in Asia, Australia, Europe and North and South America in approximately 175 experienced clinical sites.
Phase
3Span
237 weeksSponsor
Immutep S.A.S.Sofia
Recruiting
A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)
Phase
N/ASpan
176 weeksSponsor
Hoffmann-La RocheSofia
Recruiting
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Thoracic endovascular repair (TEVAR) with stent grafts is recommended for patients with acute complicated or high-risk type B aortic dissection (TBAD) as part of standard of care per current medical guidelines. Although the benefits of TEVAR with stent grafts are well established, there remains a significant risk of late complications, including aortic growth requiring reinterventions, or progression and/or rupture. In the present clinical investigation, the investigational procedure of adjunctive thoracic stent graft extension with the Allay® Aortic Stent will consist of the placement of a CE-marked Thoracic Stent Graft in the descending thoracic aorta (proximal to the celiac trunk) followed by the implantation of the Allay® Aortic Stent as adjunctive treatment of TBAD. The study objective is to demonstrate that the Allay® Aortic Stent, used as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts, results in a low rate of aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the treated abdominal segment at 12 months. The study will also allow to evaluate the incidence of Major Adverse Events (MAE) following TEVAR, at 30 days post-implantation of the Allay® Aortic Stent. Based on available data on similar devices, the objective performance goal is set to an expected proportion of 85% freedom from aortic growth requiring secondary reintervention or aortic rupture of the abdominal segment at 12 months.
Phase
N/ASpan
348 weeksSponsor
Intressa Vascular SASofia
Recruiting
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Phase
3Span
152 weeksSponsor
TakedaSofia, Sofia-Grad
Recruiting
Sofia
Recruiting
Efficacy of Neorenal Forte for the Complete Elimination of Residual Fragments
The study is being initiated to support the informed decision making by healthcare specialists on the initiation of a specific and safe formula of phytotherapeutic extracts with duration at least three months after endourological procedures, as a routine part of urolithiasis treatment, aiding the complete elimination of residual fragments, which will allow minimizing of the short-term and long-term complications. By evaluating the percentage of complete elimination of residual fragments or fragments < 2 mm in diameter, we aim to estimat the efficacy and safety of Neorenal Forte.
Phase
N/ASpan
61 weeksSponsor
Neopharm Bulgaria Ltd.Sofia
Recruiting
A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy. All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36). Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment period and Transition period. During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36. After treatment discontinuation, patients will undergo a Safety follow-up period for 4 weeks, up to week 40.
Phase
3Span
70 weeksSponsor
mAbxience Research S.L.Sofia
Recruiting