Clinical trials: in Bulgaria
Surgical Site Infection, Colon Surgery
D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection
Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated…
- Conditions
- Surgical Site Infection, Colon Surgery, Abdominal Surgery, Post-Op Infection
- Trial name
- NCT04233424
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 62 sites in United States, Bulgaria and 8 more
- Volunteers
- 977 people
- Sponsor
- PolyPid Ltd.
Hidradenitis Suppurativa
A Study to Evaluate the Efficacy and Safety of AVTX-009 in Patients With Moderate to Severe Hidradenitis Suppurativa
The main purpose of this study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS).
- Trial name
- LOTUS (NCT06603077)
- Testing
- AVTX-009 Regimen 1, AVTX-009 Regimen 2
- Where
- 89 sites in United States, Australia and 11 more
- Volunteers
- 253 people
- Sponsor
- Avalo Therapeutics, Inc.
Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer
AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
To assess the efficacy and safety of AZD9291 versus a standard of care epidermal growth factor receptor tyrosine kinase inhibitor in patients with locally advanced or Metastatic Non Small Cell Lung Cancer
- Trial name
- FLAURA (NCT02296125)
- Testing
- Erlotinib 150/100 mg, Gefitinib 250 mg
- Where
- 170 sites in United States, Australia and 28 more
- Volunteers
- 674 people
- Sponsor
- AstraZeneca
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
APOLLO-B: A Study to Evaluate Patisiran in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
The purpose of this study is to evaluate the efficacy and safety of patisiran in participants with ATTR amyloidosis with cardiomyopathy.
- Trial name
- NCT03997383
- Testing
- Patisiran
- Where
- 90 sites in United States, Argentina and 20 more
- Volunteers
- 360 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy Volunteers
Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers
The goal of this clinical trial was to learn about the safety and tolerability of an investigational drug called Benfo-oxythiamine (B-OT) in healthy male volunteers.
- Trial name
- BOOST (NCT07450833)
- Testing
- Benfo-oxythiamine
- Where
- Bulgaria
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Benfovir AG
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
- Trial name
- NCT01298323
- Testing
- Patient outreach, Vandetanib
- Where
- 66 sites in Australia, Austria and 18 more
- Volunteers
- 205 people
- Sponsor
- Sanofi
IVF Patients, Female Infertility
Endometrial Immune Profile Changes After Autologous Intrauterine PRP Treatment
The success rate after treatment by in-vitro fertilisation (IVF) strongly depends on the endometrial receptivity, which in turn is strictly connected to the endometrial immune profile.
- Trial name
- NCT07535190
- Testing
- Platelet rich plasma (PRP)
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Nadezhda Women's Health Hospital
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe…
- Trial name
- OBERON (NCT05166889)
- Testing
- Tozorakimab
- Where
- 212 sites in United States, Argentina and 19 more
- Volunteers
- 1,132 people
- Sponsor
- AstraZeneca
Primary Sjogrens Disease
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
The main purpose of the proposed study is to evaluate the efficacy of efgartigimod PH20 SC in patients with moderate-to-severe Primary Sjögren's Disease (pSjD).
- Trial name
- Unity (NCT06684847)
- Testing
- Efgartigimod PH20 SC
- Where
- 303 sites in United States, Argentina and 37 more
- Volunteers
- 631 people
- Sponsor
- argenx
Asthma
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function…
- Trial name
- ATLAS (NCT05097287)
- Testing
- Dupilumab
- Where
- 249 sites in United States, Belgium and 21 more
- Volunteers
- 1,339 people
- Sponsor
- Sanofi
Autoimmune Diseases
A Study to Evaluate the Safety, PK and PD of VIS171 in Participants (Healthy and With Autoimmune Disease)
This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).
- Trial name
- NCT05418101
- Testing
- VIS171
- Where
- 10 sites in Bulgaria, Germany and 3 more
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Allergic Diseases, Chronic Spontaneous Urticaria (CSU)
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with…
- Trial name
- CLEAR (NCT07415551)
- Testing
- Lesigercept
- Where
- 30 sites in Bulgaria, China and 2 more
- Volunteers
- 150 people
- Sponsor
- Yuhan Corporation
Hypercholesterolemia
Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia
Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia
- Trial name
- V-DIFFERENCE (NCT05192941)
- Testing
- Inclisiran Sodium
- Where
- 136 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 1,770 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Triple in Asthma Dose Finding
Primary objective The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in…
- Trial name
- Triskel (NCT02127866)
- Testing
- CHF 5259 plus Foster 100/6 µg, Foster 100/6 µg (four puffs BID)
- Where
- 44 sites in Bulgaria, Germany and 4 more
- Volunteers
- 211 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Crohn's Disease (CD)
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab.
- Trial name
- SEQUENCE (NCT04524611)
- Testing
- Risankizumab, Ustekinumab
- Where
- 300 sites in United States, Argentina and 29 more
- Volunteers
- 527 people
- Sponsor
- AbbVie
Venous Thromboembolism
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
- Trial name
- ROXI-CATH (NCT06299111)
- Testing
- REGN9933, REGN7508
- Where
- 23 sites in United States, Bulgaria and 4 more
- Volunteers
- 195 people
- Sponsor
- Regeneron Pharmaceuticals
Plaque Psoriasis, Psoriasis (PsO)
Long-term Safety and Efficacy of ESK-001 in Moderate to Severe Plaque Psoriasis
The objective of the ESK-001-018 long term extension is to evaluate the safety and efficacy of ESK-001 over time. The scientific questions it aims to answer are: How safe is taking ESK-001 long-term in people with moderate to…
- Conditions
- Plaque Psoriasis, Psoriasis (PsO), Psoriasis, Moderate Psoriasis
- Trial name
- ONWARD3 (NCT06846541)
- Testing
- Open-Label Envudeucitinib, Blinded Envudeucitinib
- Where
- 268 sites in United States, Australia and 14 more
- Volunteers
- 1,680 people
- Sponsor
- Alumis Inc
Diabetes Mellitus, Type 2
A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes
This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.
- Trial name
- NCT05144984
- Testing
- NNC0480-0389, Semaglutide
- Where
- 129 sites in United States, Bulgaria and 7 more
- Volunteers
- 500 people
- Sponsor
- Novo Nordisk A/S
Crohn's Disease
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
- Trial name
- U-ENDURE (NCT03345823)
- Testing
- Upadacitinib
- Where
- 466 sites in United States, Argentina and 47 more
- Volunteers
- 747 people
- Sponsor
- AbbVie
Relapsing Multiple Sclerosis
An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab
Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.
- Trial name
- ARTIOS (NCT04353492)
- Testing
- Ofatumumab
- Where
- 123 sites in United States, Argentina and 25 more
- Volunteers
- 562 people
- Sponsor
- Novartis Pharmaceuticals
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