Clinical trials: in Bulgaria
IgA Nephropathy
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2…
- Trial name
- NCT03608033
- Testing
- OMS721, Vehicle (D5W or saline)
- Where
- 139 sites in United States, Argentina and 21 more
- Volunteers
- 360 people
- Sponsor
- Omeros Corporation
Systemic Lupus Erythematosus
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
- Trial name
- NCT04882878
- Testing
- Nipocalimab, Standard-of-care treatment
- Where
- 86 sites in United States, Argentina and 10 more
- Volunteers
- 228 people
- Sponsor
- Janssen Research & Development, LLC
Metastatic Hormone-sensitive Prostate Cancer
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive…
- Trial name
- ARASENS (NCT02799602)
- Testing
- BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel
- Where
- 322 sites in United States, Australia and 21 more
- Volunteers
- 1,306 people
- Sponsor
- Bayer
Diabetes Mellitus, Type 2
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin icodec taken once a week in people with type 2 diabetes.
- Trial name
- COMBINE 1 (NCT05352815)
- Testing
- IcoSema, Insulin icodec
- Where
- 281 sites in United States, Australia and 20 more
- Volunteers
- 1,291 people
- Sponsor
- Novo Nordisk A/S
Axial Spondyloarthritis
A Study Evaluating the Effect of Filgotinib in Participants With Active Axial Spondyloarthritis
This study is comparing 200 milligrams (mg) of filgotinib a day with a placebo to see if filgotinib helps to treat Axial Spondyloarthritis (axSpA) and is safe to use.
- Trial name
- OLINGUITO (NCT05785611)
- Testing
- Filgotinib
- Where
- 123 sites in Belgium, Bulgaria and 16 more
- Volunteers
- 495 people
- Sponsor
- Alfasigma S.p.A.
Renal Impairment
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment
The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AZD5462 in participants with impaired renal function.
- Trial name
- GLITTER (NCT06661733)
- Testing
- AZD5462
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Congestive Heart Failure
Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure
This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered via antegrade intracoronary artery infusion, in…
- Trial name
- GenePHIT (NCT05598333)
- Testing
- AB-1002
- Where
- 96 sites in United States, Austria and 10 more
- Volunteers
- 150 people
- Sponsor
- AskBio Inc
Systemic Lupus Erythematosus
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
- Trial name
- POETYK SLE-1 (NCT05617677)
- Testing
- Deucravacitinib
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 516 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
- Trial name
- POETYK SLE-2 (NCT05620407)
- Testing
- Deucravacitinib
- Where
- 180 sites in United States, Argentina and 20 more
- Volunteers
- 513 people
- Sponsor
- Bristol-Myers Squibb
Vasomotor Symptoms Associated With Menopause, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause
Researchers are looking for a better way to treat women who have hot flashes after they have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the…
- Trial name
- OASIS-3 (NCT05030584)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 86 sites in United States, Belgium and 7 more
- Volunteers
- 628 people
- Sponsor
- Bayer
Severe Hypertriglyceridemia
CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
- Trial name
- NCT05681351
- Testing
- Olezarsen
- Where
- 262 sites in United States, Argentina and 31 more
- Volunteers
- 885 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Breast Cancer
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive…
- Trial name
- APHINITY (NCT01358877)
- Testing
- 5-Fluorouracil, Carboplatin, Cyclophosphamide
- Where
- 546 sites in United States, Argentina and 40 more
- Volunteers
- 4,804 people
- Sponsor
- Hoffmann-La Roche
Allergic Rhinoconjunctivitis, Birch Pollen Allergy
Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma
Allergic rhinoconjunctivitis due to birch pollen is a seasonal problem which manifests as a combination of nasal symptoms (such as congestion, runny nose, sneezing, itching of the nose) and ocular symptoms (such as red, itchy and…
- Trial name
- YOBI (NCT05668390)
- Testing
- STALORAL® Birch 300 IR
- Where
- 62 sites in Austria, Bulgaria and 10 more
- Volunteers
- 553 people
- Sponsor
- Stallergenes Greer
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib.
- Trial name
- NCT03589326
- Testing
- Ponatinib, Imatinib, Vincristine
- Where
- 92 sites in United States, Argentina and 18 more
- Volunteers
- 245 people
- Sponsor
- Takeda
Aneurysm Cerebral, Bifurcation
LUMENS-1 EU EFS CIP
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA).
- Conditions
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm
- Trial name
- NCT06761365
- Testing
- LuSeed Aneurysm Embolization System
- Where
- 6 sites in Bulgaria, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- LuSeed Vascular LTD.
Asthma
A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
- Trial name
- NCT06900816
- Testing
- CHF 6001
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Acute Bacterial Skin and Skin Structure Infection
Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
This protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric…
- Trial name
- NCT05599295
- Testing
- Orbactiv, Kimyrsa
- Where
- 23 sites in United States, Bulgaria and 6 more
- Volunteers
- 118 people
- Sponsor
- Melinta Therapeutics, LLC
Chronic Kidney Disease, Atherosclerotic Cardiovascular Disease
A Phase 1b Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants With Established Atherosclerotic Cardiovascular and Chronic Kidney Disease.
The purpose of this study is to evaluate the safety, tolerability and the pharmacodynamics (PD) of AZD4144 following oral administration in participants with atherosclerotic cardiovascular disease (ASCVD) and chronic kidney…
- Trial name
- NCT06675175
- Testing
- AZD4144
- Where
- 15 sites in United States, Bulgaria and 2 more
- Volunteers
- 29 people
- Sponsor
- AstraZeneca
Hereditary Angioedema, Hereditary Angioedema Type I
Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand…
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- RAPIDe-3 (NCT06343779)
- Where
- 76 sites in United States, Argentina and 27 more
- Volunteers
- 134 people
- Sponsor
- Pharvaris Netherlands B.V.
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