Clinical trials: in Bulgaria
Haemophilia A
A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A.
- Trial name
- pathfinder9 (NCT04574076)
- Testing
- Turoctocog alfa pegol (N8-GP)
- Where
- 27 sites in Austria, Bulgaria and 13 more
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Metastatic Colorectal Cancer
Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.
- Trial name
- SOLSTICE (NCT03869892)
- Testing
- Trifluridine/tipiracil hydrochloride (S95005), Capecitabine, Bevacizumab experimental
- Where
- 190 sites in Argentina, Australia and 23 more
- Volunteers
- 856 people
- Sponsor
- Institut de Recherches Internationales Servier
Healthy Volunteers, Haemophilia A With or Without Inhibitors
A Research Study Investigating Mim8 in People With Haemophilia A
This study is investigating how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medication that will be used for prevention of bleeding episodes.
- Trial name
- FRONTIER1 (NCT04204408)
- Testing
- NNC0365-3769 (Mim8)
- Where
- 40 sites in United States, Austria and 10 more
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the…
- Trial name
- A DUE (NCT03904693)
- Testing
- FDC macitentan/tadalafil, Macitentan 10 mg, Tadalafil 40 mg
- Where
- 148 sites in United States, Australia and 17 more
- Volunteers
- 187 people
- Sponsor
- Actelion
Polycythemia Vera
Study to Assess SLN124 in Patients With Polycythemia Vera
This is a Phase 1/2, multicenter study with an open-label dose escalation followed by a randomized placebo controlled and double-blind phase of SLN124 in adult patients with Polycythemia Vera (PV) to assess the safety…
- Trial name
- SLN (NCT05499013)
- Testing
- SLN124
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 69 people
- Sponsor
- Silence Therapeutics plc
Rheumatoid Arthritis
SBD121, a Synbiotic Medical Food for RA Management
The aim of this randomised, double-blind, placebo controlled clinical food trial is to determine if the medical food SBD121 Synbiotic (prebiotic and probiotic) will aid in the dietary management of symptoms of early rheumatoid…
- Trial name
- NCT06005220
- Testing
- SBD121
- Where
- 22 sites in Australia, Bulgaria and 2 more
- Volunteers
- 143 people
- Sponsor
- Solarea Bio, Inc
Prurigo Nodularis
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
- Trial name
- TRuE-PN2 (NCT05764161)
- Testing
- Ruxolitinib Cream, Vehicle Cream
- Where
- 76 sites in United States, Australia and 11 more
- Volunteers
- 190 people
- Sponsor
- Incyte Corporation
Uncontrolled Asthma
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)
- Trial name
- TANGO (NCT06029595)
- Testing
- Experimental: CHF6001 3200 μg
- Where
- 187 sites in Argentina, Bulgaria and 12 more
- Volunteers
- 517 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hereditary Angioedema, Hereditary Angioedema Type I
Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
This study evaluates the efficacy of orally administered deucrictibant for the acute treatment of attacks in patients with hereditary angioedema (HAE).
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- RAPIDe-1 (NCT04618211)
- Testing
- Deucrictibant
- Where
- 36 sites in United States, Bulgaria and 11 more
- Volunteers
- 74 people
- Sponsor
- Pharvaris Netherlands B.V.
Ulcerative Colitis, Colitis, Ulcerative
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
- Trial name
- NCT05370885
- Testing
- VE202, Vancomycin Oral Capsule
- Where
- 49 sites in United States, Australia and 8 more
- Volunteers
- 114 people
- Sponsor
- Vedanta Biosciences, Inc.
Chronic Obstructive Pulmonary Disease
A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)
The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.
- Trial name
- PILASTER (NCT04636801)
- Testing
- Experimental: CHF6001 1600µg, Experimental: CHF6001 3200µg
- Where
- 447 sites in United States, Albania and 28 more
- Volunteers
- 4,710 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Non-Cystic Fibrosis Bronchiectasis
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
- Trial name
- ASPEN (NCT04594369)
- Testing
- Brensocatib 10 mg, Brensocatib 25 mg
- Where
- 373 sites in United States, Argentina and 34 more
- Volunteers
- 1,767 people
- Sponsor
- Insmed Incorporated
Eosinophilic Asthma
Phase III Long-Term Extension Study With Dexpramipexole
The goal of this clinical trial] is to evaluate the long term safety of dexpramipexole treatment in participants with severe asthma, aged ≥18 years, on Global Initiative for Asthma (GINA) 2021 [GINA, 2021] Step 4 or 5 therapy and…
- Trial name
- EXHALE-5 (NCT06388889)
- Testing
- Dexpramipexole Dihydrochloride
- Where
- 103 sites in United States, Argentina and 13 more
- Volunteers
- 509 people
- Sponsor
- Areteia Therapeutics
Eosinophilic Asthma, Asthma; Eosinophilic
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.
- Conditions
- Eosinophilic Asthma, Asthma; Eosinophilic, Asthma
- Trial name
- EXHALE-2 (NCT05763121)
- Testing
- Dexpramipexole Dihydrochloride
- Where
- 401 sites in United States, Argentina and 18 more
- Volunteers
- 1,061 people
- Sponsor
- Areteia Therapeutics
Diabetes Mellitus, Type 2
A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.
- Trial name
- ONWARDS 2 (NCT04770532)
- Testing
- Insulin degludec, Insulin Icodec
- Where
- 88 sites in United States, Bulgaria and 7 more
- Volunteers
- 526 people
- Sponsor
- Novo Nordisk A/S
Hereditary Angioedema
A Study to Assess the Long-Term Safety and Efficacy of Donidalorsen in the Prophylactic Treatment of Hereditary Angioedema (HAE)
The purpose of this study is to evaluate the long-term safety and efficacy of donidalorsen in people with HAE and the effects of donidalorsen on the number of HAE attacks and their impact on quality of life (QoL).
- Trial name
- NCT05392114
- Testing
- Donidalorsen
- Where
- 50 sites in United States, Belgium and 12 more
- Volunteers
- 154 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Asthma
Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller…
- Trial name
- WAYFINDER (NCT05274815)
- Testing
- Tezepelumab
- Where
- 77 sites in United States, Argentina and 9 more
- Volunteers
- 305 people
- Sponsor
- AstraZeneca
Masseter Muscle Prominence
A Study to Assess the Effectiveness of BOTOX (Botulinum Toxin Type A) Injections for the Change of Masseter Muscle Prominence in Adult Participants
The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a…
- Trial name
- MMP EU P3 (NCT06068855)
- Testing
- BOTOX
- Where
- 27 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 249 people
- Sponsor
- AbbVie
IgA Nephropathy
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2…
- Trial name
- NCT03608033
- Testing
- OMS721, Vehicle (D5W or saline)
- Where
- 139 sites in United States, Argentina and 21 more
- Volunteers
- 360 people
- Sponsor
- Omeros Corporation
Diabetes Mellitus, Type 2
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines.
- Trial name
- PIONEER PLUS (NCT04707469)
- Testing
- Oral semaglutide
- Where
- 228 sites in United States, Australia and 13 more
- Volunteers
- 1,606 people
- Sponsor
- Novo Nordisk A/S
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