Clinical trials: in Bulgaria
Ulcerative Colitis
A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Ulcerative Colitis (ROSETTA)
ROSETTA STUDY: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe ulcerative colitis (UC)
- Trial name
- NCT06127043
- Testing
- Rosnilimab
- Where
- 100 sites in United States, Austria and 13 more
- Volunteers
- 132 people
- Sponsor
- AnaptysBio, Inc.
Type 1 Diabetes Mellitus
The Effect of Diabetes M Application Use Versus Conventional Bolus Calculation in Patients With Type 1 Diabetes Mellitus
Managing insulin dosing for diabetes, particularly for those with type 1 diabetes mellitus, is a complex process that requires precision.
- Trial name
- NCT06974201
- Testing
- Diabetes M bolus calculator, Diabetes M app
- Where
- Bulgaria
- Volunteers
- 30 people
- Sponsor
- Medical University of Sofia
Small Cell Lung Cancer
Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and…
- Trial name
- NCT03041311
- Testing
- Trilaciclib, Carboplatin, Etoposide
- Where
- 45 sites in United States, Bulgaria and 5 more
- Volunteers
- 107 people
- Sponsor
- G1 Therapeutics, Inc.
Type2 Diabetes, Dyslipidemia
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of: nonfatal Myocardial Infarction (MI)…
- Trial name
- PROMINENT (NCT03071692)
- Testing
- K-877
- Where
- 888 sites in United States, Argentina and 23 more
- Volunteers
- 10,544 people
- Sponsor
- Kowa Research Institute, Inc.
Renal Impairment, Heart Failure
A Phase Ib Study of AZD5462 on Top of Dapagliflozin in Participants With Heart Failure and Moderate Renal Impairment
A study to investigate the effects and safety of AZD5462 on top of dapagliflozin in participants with heart failure and moderate renal impairment.
- Trial name
- AURORA (NCT06639087)
- Testing
- AZD5462, Dapagliflozin
- Where
- Bulgaria
- Volunteers
- 8 people
- Sponsor
- AstraZeneca
Psoriatic Arthritis
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to…
- Trial name
- SELECT - PsA 1 (NCT03104400)
- Testing
- Adalimumab, Upadacitinib
- Where
- 345 sites in United States, Argentina and 44 more
- Volunteers
- 1,705 people
- Sponsor
- AbbVie
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With a Next-Generation Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.
- Trial name
- NCT05573464
- Testing
- BGF MDI HFO 320/14.4/9.6 μg, BGF MDI HFA 320/14.4/9.6 μg
- Where
- 91 sites in United States, Argentina and 7 more
- Volunteers
- 559 people
- Sponsor
- AstraZeneca
Hepatic Function Abnormal
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of…
- Trial name
- NCT05607173
- Testing
- Fexinidazole (HOE239)
- Where
- 2 sites in Bulgaria, France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatitis B, Chronic
A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant…
- Trial name
- Piranga (NCT04225715)
- Testing
- Nucleos(t)ide (NUC), CpAM (RO7049389), TLR7 (RO7020531)
- Where
- 33 sites in Bulgaria, Canada and 11 more
- Volunteers
- 281 people
- Sponsor
- Hoffmann-La Roche
Depressive Disorder, Major
A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment
The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI)…
- Trial name
- ESCAPE-LTE (NCT04829318)
- Testing
- Esketamine, SSRI/SNRI
- Where
- 59 sites in Argentina, Belgium and 12 more
- Volunteers
- 183 people
- Sponsor
- Janssen-Cilag Ltd.
Hemophilia A
Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A
Primary objective To assess the half-life of BIVV001, Standard Half-Life (SHL) rFVIII and Extended Half-Life (EHL) rFVIII after a single intravenous (IV) injection Secondary objectives To characterize additional pharmacokinetic…
- Trial name
- NCT05042440
- Testing
- Efanesoctocog alfa, Octocog alfa, Rurioctocog alfa pegol
- Where
- Bulgaria
- Volunteers
- 13 people
- Sponsor
- Sanofi
Melanoma
A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
The purpose of this study was to evaluate safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in patients with BRAF V600 mutant, unresectable…
- Trial name
- COMBI-i (NCT02967692)
- Testing
- Spartalizumab, Dabrafenib, Trametinib
- Where
- 179 sites in United States, Argentina and 27 more
- Volunteers
- 568 people
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (10 mg QD and 30 mg QD) in…
- Trial name
- NCT05227690
- Testing
- Emraclidine 10 mg, Emraclidine 30 mg
- Where
- 25 sites in United States, Bulgaria
- Volunteers
- 385 people
- Sponsor
- AbbVie
Crohn Disease
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT03467958
- Testing
- Ozanimod
- Where
- 766 sites in United States, Argentina and 47 more
- Volunteers
- 854 people
- Sponsor
- Celgene
Factor VIII Deficiency
A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
Primary Objective: To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- Trial name
- XTEND-1 (NCT04161495)
- Testing
- efanesoctocog alfa (BIVV001)
- Where
- 47 sites in United States, Argentina and 17 more
- Volunteers
- 159 people
- Sponsor
- Bioverativ, a Sanofi company
Binge-Eating Disorder
EXOMIND (BTL-995) for Reduction of Binge-eating
The goal of this clinical trial is to evaluate if the treatment with the BTL-995-rTMS device is able to reduce binge eating in adults above the age of 22 years.
- Trial name
- NCT06910592
- Testing
- Treatment with BTL-995-rTMS
- Where
- Bulgaria
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- BTL Industries Ltd.
Myeloproliferative Neoplasm, COVID
Myeloproliferative Neoplasms (MPN) and COVID-19
An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death.
- Trial name
- MPN-COVID (NCT04385160)
- Where
- 44 sites in United States, Bulgaria and 7 more
- Volunteers
- 552 people
- Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Breast Cancer
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen…
- Trial name
- AMEERA-5 (NCT04478266)
- Testing
- SAR439859, Palbociclib, Letrozole
- Where
- 249 sites in United States, Argentina and 28 more
- Volunteers
- 1,068 people
- Sponsor
- Sanofi
Pompe Disease (Late-onset)
A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease
This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.
- Trial name
- PROPEL (NCT03729362)
- Testing
- Cipaglucosidase Alfa, Miglustat, Alglucosidase Alfa
- Where
- 73 sites in United States, Argentina and 22 more
- Volunteers
- 125 people
- Sponsor
- Amicus Therapeutics
Carcinoma, Non Small Cell Lung
A Study of Aflibercept Versus Placebo in Patients With Second-Line Docetaxel for Locally Advanced or Metastatic Non-Small-Cell Lung Cancer
The primary objective of the study was to demonstrate overall survival improvement for aflibercept + docetaxel compared to docetaxel + placebo as second line treatment for participants with locally advanced or metastatic…
- Trial name
- VITAL (NCT00532155)
- Testing
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), Docetaxel (Taxotere®), Dexamethasone (pre- and post-medication for docetaxel)
- Where
- 32 sites in United States, Argentina and 30 more
- Volunteers
- 913 people
- Sponsor
- Sanofi
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