Clinical trials: in Bulgaria
Mild Asthma
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d. delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in…
- Trial name
- NCT02892344
- Testing
- QMF149 150/80 μg, MF 200 μg
- Where
- 123 sites in Bulgaria, Chile and 20 more
- Volunteers
- 802 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04987307
- Testing
- Efavaleukin alfa
- Where
- 200 sites in United States, Argentina and 24 more
- Volunteers
- 221 people
- Sponsor
- Amgen
Resistant Hypertension
An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.
The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC)…
- Trial name
- NCT05562934
- Testing
- XXB750 drug
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 189 people
- Sponsor
- Novartis Pharmaceuticals
Amyloidosis, Hereditary, Transthyretin Amyloidosis
HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)
The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis).
- Trial name
- NCT03759379
- Testing
- Patisiran, Vutrisiran
- Where
- 64 sites in United States, Argentina and 20 more
- Volunteers
- 164 people
- Sponsor
- Alnylam Pharmaceuticals
Systemic Lupus Erythematosus
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
- Trial name
- NCT05306574
- Testing
- Telitacicept
- Where
- 78 sites in United States, Argentina and 13 more
- Volunteers
- 91 people
- Sponsor
- Vor Biopharma
Hidradenitis Suppurativa (HS)
A Study to Evaluate the Efficacy and Safety of Povorcitinib (INCB054707) in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)
The purpose of this study is to evaluate the efficacy and safety of Povorcitinib (INCB054707) in participants with moderate to severe Hidradenitis Suppurativa (HS) over a 12-week placebo-controlled period, followed by a 42-week…
- Trial name
- STOP-HS2 (NCT05620836)
- Testing
- Povorcitinib
- Where
- 101 sites in United States, Australia and 9 more
- Volunteers
- 619 people
- Sponsor
- Incyte Corporation
Myelofibrosis (MF)
Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger.
- Trial name
- TRANSFORM-2 (NCT04468984)
- Testing
- Navitoclax, Ruxolitinib, Best Available Therapy (BAT)
- Where
- 229 sites in United States, Australia and 28 more
- Volunteers
- 330 people
- Sponsor
- AbbVie
Congenital Hyperinsulinism
RZ358 Treatment for Congenital Hyperinsulinism
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to…
- Trial name
- sunRIZE (NCT06208215)
- Testing
- RZ358 (5-10 mg/kg) + SOC
- Where
- 18 sites in United States, Bulgaria and 11 more
- Volunteers
- 56 people
- Sponsor
- Rezolute
Renal Insufficiency, Chronic, Hyperkalemia
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's…
- Trial name
- STABILIZE-CKD (NCT05056727)
- Testing
- Sodium Zirconium Cyclosilicate (SZC), Lisinopril, Valsartan
- Where
- 276 sites in United States, Argentina and 19 more
- Volunteers
- 1,112 people
- Sponsor
- AstraZeneca
Primary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to…
- Trial name
- PERSEUS (NCT04458051)
- Testing
- Tolebrutinib
- Where
- 277 sites in United States, Argentina and 40 more
- Volunteers
- 767 people
- Sponsor
- Sanofi
Chronic Kidney Disease
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
The primary objective of this study is to demonstrate the superiority of MCI-196 over placebo and non-inferiority with simvastatin in reducing serum low-density lipoprotein (LDL)-cholesterol in subjects with chronic kidney…
- Trial name
- NCT00858637
- Testing
- MCI-196, Simvastatin
- Where
- 39 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 260 people
- Sponsor
- Tanabe Pharma Corporation
Functional Constipation
A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.
- Trial name
- NCT05760313
- Testing
- Linaclotide
- Where
- 38 sites in United States, Bulgaria and 5 more
- Volunteers
- 19 people
- Sponsor
- AbbVie
Ulcerative Colitis
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT02531126
- Testing
- RPC1063
- Where
- 41 sites in United States, Australia and 18 more
- Volunteers
- 877 people
- Sponsor
- Celgene
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
- Trial name
- MARITIME-2 (NCT06858878)
- Testing
- Maridebart cafraglutide
- Where
- 187 sites in United States, Argentina and 11 more
- Volunteers
- 1,105 people
- Sponsor
- Amgen
Hepatitis B, Chronic
A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy
This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA…
- Trial name
- NCT05276297
- Testing
- GSK3228836, GSK3528869A, Control
- Where
- 51 sites in Belgium, Bulgaria and 13 more
- Volunteers
- 174 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active…
- Trial name
- NCT06570772
- Testing
- AVT16, Vedolizumab
- Where
- 100 sites in Argentina, Bulgaria and 9 more
- Volunteers
- 301 people
- Sponsor
- Alvotech Swiss AG
Complicated Urinary Tract Infection, Acute Pyelonephritis
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated…
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
- Trial name
- Integral-1 (NCT05887908)
- Testing
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, imipenem/cilastatin
- Where
- 61 sites in Bulgaria, China and 7 more
- Volunteers
- 614 people
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
- Trial name
- pathfinder™6 (NCT02137850)
- Testing
- turoctocog alfa pegol
- Where
- 96 sites in United States, Algeria and 21 more
- Volunteers
- 124 people
- Sponsor
- Novo Nordisk A/S
Healthy Male Subjects
Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Biosimilar Denosumab With Prolia® in Healthy Adult Male Volunteers
This is a randomized, double-blind, three-arm, parallel-group, single-dose study to demonstrate bioequivalence of ENZ215 and EU- and US-sourced Prolia after a single 60-mg dose administered subcutaneously in healthy adult male…
- Trial name
- NCT05245669
- Testing
- ENZ215, EU Sourced Prolia, US Sourced Prolia
- Where
- 2 sites in Bulgaria, Poland
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Enzene Biosciences Ltd.
Congenital Bleeding Disorder, Haemophilia B
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.
- Trial name
- paradigm™6 (NCT02141074)
- Testing
- nonacog beta pegol
- Where
- 93 sites in United States, Algeria and 22 more
- Volunteers
- 54 people
- Sponsor
- Novo Nordisk A/S
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