Clinical trials: in Bulgaria
Crohn's Disease
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
- Trial name
- CAPE (NCT02130362)
- Where
- 148 sites in United States, Bosnia and Herzegovina and 20 more
- Volunteers
- 1,446 people
- Sponsor
- AbbVie
Ulcerative Colitis
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.
- Trial name
- GLADIATOR UC (NCT04607837)
- Testing
- Etrasimod
- Where
- 288 sites in United States, Australia and 16 more
- Volunteers
- 234 people
- Sponsor
- Pfizer
Wet Macular Degeneration
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with…
- Trial name
- NCT03823300
- Testing
- Faricimab, Aflibercept
- Where
- 137 sites in United States, Argentina and 19 more
- Volunteers
- 658 people
- Sponsor
- Hoffmann-La Roche
Diabetic Macular Edema
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W)…
- Trial name
- NCT03622580
- Testing
- Aflibercept, Faricimab
- Where
- 185 sites in United States, Austria and 14 more
- Volunteers
- 940 people
- Sponsor
- Hoffmann-La Roche
PCOS, Myo-inositol-resistance
Myo-inositol Plus Alpha-lactalbumin in PCOS Myo-inositol-resistant Patients
The investigator's aim is to evaluate if the combination of myo-inositol and alpha-lactalbumin can overcome the resistance to myo-inositol in PCOS patients
- Trial name
- NCT03667443
- Testing
- Myo-inositol + folic a. + α-lactalbumin, Myo-inositol + folic a.
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Lo.Li.Pharma s.r.l
COVID-19
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing…
- Trial name
- NCT04960202
- Testing
- PF-07321332, Ritonavir
- Where
- 201 sites in United States, Argentina and 18 more
- Volunteers
- 2,091 people
- Sponsor
- Pfizer
Safety, Pharmacokinetics
Single and Multiple Intravenous Administrations of Estetrol (E4) in Healthy Adult Volunteers
The Sponsor intends to develop an intravenous (i.v.) formulation of E4 for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). E4 has not been administered intravenously to humans yet.
- Trial name
- NCT05460065
- Testing
- single E4 28.3 mg, single E4 94.4 mg, multiple E4 94.4 mg
- Where
- Bulgaria
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- NEURALIS s.a.
Influenza
Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening.
- Trial name
- NCT03969212
- Testing
- Baloxavir Marboxil
- Where
- 142 sites in United States, Bulgaria and 14 more
- Volunteers
- 4,138 people
- Sponsor
- Hoffmann-La Roche
Congenital Afibrinogenemia, Congenital Hypofibrinogenemia
Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency
This was a prospective, open-label, multicenter, phase I/III study investigating the 14-day single-dose pharmacokinetic and pharmacodynamic properties, efficacy and safety of BT524 following intravenous administration in the…
- Trial name
- NCT02065882
- Testing
- BT524 (Part I), BT524 (Part II)
- Where
- 6 sites in Bulgaria, Egypt and 3 more
- Volunteers
- 67 people
- Sponsor
- Biotest
Eczema, Atopic Dermatitis
Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study
This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic…
- Trial name
- STREAM-AD (NCT05131477)
- Testing
- Amlitelimab
- Where
- 103 sites in United States, Australia and 10 more
- Volunteers
- 390 people
- Sponsor
- Kymab Limited
Crohn Disease
VTX958 for the Treatment of Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind placebo-controlled, parallel group study to evaluate the efficacy and safety of VTX958 in participants with moderately to severely active Crohn's Disease.
- Trial name
- Harmony-CD (NCT05688852)
- Testing
- VTX958
- Where
- 105 sites in United States, Australia and 13 more
- Volunteers
- 107 people
- Sponsor
- Ventyx Biosciences, Inc
Non-relapsing Secondary Progressive Multiple Sclerosis
Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES)
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic…
- Trial name
- HERCULES (NCT04411641)
- Testing
- Tolebrutinib
- Where
- 306 sites in United States, Argentina and 29 more
- Volunteers
- 1,131 people
- Sponsor
- Sanofi
Relapsing Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)
Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary…
- Trial name
- GEMINI 1 (NCT04410978)
- Testing
- Tolebrutinib, Teriflunomide
- Where
- 179 sites in United States, Austria and 22 more
- Volunteers
- 974 people
- Sponsor
- Sanofi
Schizophrenia
Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Participants With Cognitive Impairment Associated With Schizophrenia
Study to evaluate the safety and efficacy of luvadaxistat compared with placebo on improving cognitive performance in participants with schizophrenia.
- Trial name
- ERUDITE (NCT05182476)
- Testing
- Luvadaxistat
- Where
- 49 sites in United States, Bulgaria and 3 more
- Volunteers
- 216 people
- Sponsor
- Neurocrine Biosciences
Chronic Thromboembolic Pulmonary Hypertension
A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).
- Trial name
- MACiTEPH (NCT04271475)
- Testing
- Macitentan
- Where
- 168 sites in United States, Argentina and 31 more
- Volunteers
- 127 people
- Sponsor
- Actelion
Partial Epilepsy
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance…
- Trial name
- NCT01866111
- Testing
- YKP3089
- Where
- 67 sites in United States, Australia and 13 more
- Volunteers
- 437 people
- Sponsor
- SK Life Science, Inc.
Asthma
Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma
The goal of asthma treatment is to achieve and maintain asthma control and to reduce the future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most effective anti- inflammatory treatment for all…
- Trial name
- NCT03248128
- Testing
- FF/VI via ELLIPTA DPI, FF via ELLIPTA DPI
- Where
- 183 sites in United States, Argentina and 14 more
- Volunteers
- 906 people
- Sponsor
- GlaxoSmithKline
Multiple Sclerosis
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis
The study AC-058B301 (OPTIMUM; NCT02425644) has been designed to investigate the efficacy, safety and tolerability of ponesimod in subjects with relapsing multiple sclerosis (RMS).
- Trial name
- OPTIMUM-LT (NCT03232073)
- Testing
- Ponesimod
- Where
- 148 sites in United States, Belarus and 26 more
- Volunteers
- 877 people
- Sponsor
- Actelion
Cushing Syndrome, Cushing Disease
Open-label Treatment in Cushing's Syndrome
This is a long-term, open-label extension study of levoketoconazole in participants with endogenous Cushing's Syndrome.
- Trial name
- OPTICS (NCT03621280)
- Testing
- Levoketoconazole
- Where
- 30 sites in United States, Bulgaria and 9 more
- Volunteers
- 51 people
- Sponsor
- Cortendo AB
Hyperkalemia
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.
- Trial name
- NCT04847232
- Testing
- Sodium Zirconium Cyclosilicate (SZC)
- Where
- 340 sites in United States, Argentina and 24 more
- Volunteers
- 2,690 people
- Sponsor
- AstraZeneca