Clinical trials: in Bulgaria
Chronic Hepatitis B Infection
A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.
- Trial name
- B-SUPREME (NCT06963710)
- Testing
- ALG-000184, TDF
- Where
- 41 sites in United States, Bulgaria and 12 more
- Volunteers
- 200 people
- Sponsor
- Aligos Therapeutics
Obesity
AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week.
- Trial name
- AMAZE 12 (NCT07503210)
- Testing
- NNC0487-0111
- Where
- 72 sites in United States, Argentina and 10 more
- Volunteers
- 606 people
- Sponsor
- Novo Nordisk A/S
Cardiomyopathy, Secondary, Arrhythmias, Cardiac
Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
The PACEVALUE study is a large, international observational study aiming to improve the treatment of patients receiving cardiac implantable electronic devices (CIEDs) such as pacemakers, implantable cardioverter-defibrillators…
- Conditions
- Cardiomyopathy, Secondary, Arrhythmias, Cardiac, Heart Failure, Pacing Induced Cardiomyopathy
- Trial name
- PACEVALUE (NCT07276139)
- Where
- 13 sites in Australia, Bulgaria and 5 more
- Volunteers
- 4,500 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Lupus Erythematosus, Systemic
Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus
The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
- Trial name
- OPUS OLE (NCT06475742)
- Testing
- Cenerimod
- Where
- 122 sites in United States, Argentina and 24 more
- Volunteers
- 680 people
- Sponsor
- Viatris Innovation GmbH
Diffuse Large B-Cell Lymphoma
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections).
- Trial name
- EPCORE DLBCL-2 (NCT05578976)
- Testing
- Epcoritamab, Cyclophosphamide, Rituximab
- Where
- 331 sites in United States, Australia and 29 more
- Volunteers
- 900 people
- Sponsor
- Genmab
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.
The main objective of Part 1 is to evaluate the safety and tolerability of bemarituzumab plus 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) and nivolumab.
- Trial name
- FORTITUDE-102 (NCT05111626)
- Testing
- Bemarituzumab, Nivolumab, Chemotherapy
- Where
- 348 sites in United States, Argentina and 27 more
- Volunteers
- 515 people
- Sponsor
- Amgen
SARS-CoV Infection
VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
- Trial name
- VERU-111 (NCT04842747)
- Testing
- VERU-111
- Where
- 58 sites in United States, Argentina and 4 more
- Volunteers
- 204 people
- Sponsor
- Veru Inc.
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507203
- Testing
- ABX464
- Where
- 264 sites in United States, Argentina and 22 more
- Volunteers
- 639 people
- Sponsor
- Abivax S.A.
Acute Pyelonephritis, Complicated Urinary Tract Infection
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
The primary objective of the study is to assess the safety and tolerability of meropenem-vaborbactam administered by intravenous (IV) infusion in children 3 months and above to less than 12 years with complicated urinary tract…
- Trial name
- NCT06672978
- Testing
- Meropenem-Vaborbactam, Antibiotics
- Where
- 26 sites in United States, Bulgaria and 4 more
- Volunteers
- 66 people
- Sponsor
- Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Arthritis, Psoriatic
Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis
This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis.
- Trial name
- NCT05640245
- Testing
- Sonelokimab, Adalimumab
- Where
- 42 sites in United States, Bulgaria and 6 more
- Volunteers
- 207 people
- Sponsor
- MoonLake Immunotherapeutics AG
Heart Failure, Acute Heart Failure
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
- Trial name
- REDEFINE-HF (NCT06008197)
- Testing
- Finerenone
- Where
- 356 sites in United States, Argentina and 24 more
- Volunteers
- 5,200 people
- Sponsor
- Colorado Prevention Center
Triple Negative Breast Neoplasms
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA…
- Trial name
- EPIK-B3 (NCT04251533)
- Testing
- alpelisib, nab-paclitaxel
- Where
- 78 sites in United States, Argentina and 28 more
- Volunteers
- 137 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Angioedema, HAE
STOP-HAE: A Phase 3 Study of ADX-324 in HAE
This study will evaluate the efficacy and safety of ADX-324 in participants with Type 1 or Type 2 hereditary angioedema. The study will also evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD), and health-related…
- Conditions
- Hereditary Angioedema, HAE, Hereditary Angioedema - Type 1, Hereditary Angioedema - Type 2
- Trial name
- STOP-HAE (NCT06960213)
- Testing
- ADX-324
- Where
- 70 sites in United States, Argentina and 22 more
- Volunteers
- 90 people
- Sponsor
- ADARx Pharmaceuticals, Inc.
Hypercholesterolaemia
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood.
- Trial name
- NCT07619131
- Testing
- Laroprovstat, Rosuvastatin 1, Rosuvastatin 2
- Where
- 152 sites in United States, Bulgaria and 9 more
- Volunteers
- 600 people
- Sponsor
- AstraZeneca
Asthma
Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).
The CLI-05993AB6-03 Study is an interventional study designed to investigate the safety and efficacy of a new low global warming potential propellant (HFA-152a) compared to the currently approved one (HFA-134a) in the medication…
- Trial name
- TRECOS (NCT06264674)
- Testing
- CHF5993 200/6/12.5 μg pMDI HFA-152a, Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a
- Where
- 118 sites in Bulgaria, Czechia and 12 more
- Volunteers
- 827 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hormone-Sensitive Prostate Cancer
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in…
- Trial name
- CAPItello-281 (NCT04493853)
- Testing
- Capivasertib, Abiraterone Acetate
- Where
- 323 sites in United States, Argentina and 30 more
- Volunteers
- 1,012 people
- Sponsor
- AstraZeneca
Chronic Obstructive Pulmonary Disease
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Phase II, randomized, double-blind, placebo-controlled, parallel-group clinical trial of lebrikizumab in participants with COPD and a history of exacerbations who are treated with inhaled corticosteroid (ICS) and at least one…
- Trial name
- NCT02546700
- Testing
- Lebrikizumab
- Where
- 63 sites in United States, Argentina and 7 more
- Volunteers
- 309 people
- Sponsor
- Hoffmann-La Roche
Overweight, Obesity
Research Study on How Well Oral Semaglutide Works for Weight Loss in Adults With Excess Body Weight
The purpose of this study is to see how oral semaglutide, when taken in lower doses help lowering of body weight in participants with excess body weight when compared to 'dummy' tablets (placebo).
- Trial name
- OASIS 5 (NCT07770841)
- Testing
- Semaglutide
- Where
- 62 sites in United States, Belgium and 8 more
- Volunteers
- 450 people
- Sponsor
- Novo Nordisk A/S
Thyroid Eye Disease
A Trial Investigating Lu AG22515 in Adult Participants With Moderate-to-Severe Thyroid Eye Disease
This trial will evaluate the effects of Lu AG22515 in adult men and women with moderate-to-severe thyroid eye disease (TED). TED is an autoimmune condition closely related to Graves' Disease.
- Trial name
- NCT06557850
- Testing
- Lu AG22515
- Where
- 6 sites in Bosnia and Herzegovina, Bulgaria and 1 more
- Volunteers
- 20 people
- Sponsor
- H. Lundbeck A/S
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