Clinical trials: in North Macedonia
Myasthenia Gravis, Generalized
A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)
The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
- Trial name
- MAGIC (NCT06282159)
- Testing
- Claseprubart
- Where
- 56 sites in United States, Argentina and 12 more
- Volunteers
- 65 people
- Sponsor
- Dianthus Therapeutics
Surgical Site Infection, Colon Surgery
D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)
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
- D-PLEX312 (NCT04411199)
- Testing
- D-PLEX, Standard of Care (SoC)
- Where
- 58 sites in United States, Bosnia and Herzegovina and 11 more
- Volunteers
- 975 people
- Sponsor
- PolyPid Ltd.
Melanoma
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring…
- Trial name
- NCT06153238
- Testing
- GME751, Keytruda - EU, Keytruda - US
- Where
- 61 sites in United States, Bosnia and Herzegovina and 16 more
- Volunteers
- 322 people
- Sponsor
- Sandoz
Acute Coronary Syndrome
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death…
- Trial name
- LIBREXIA-ACS (NCT05754957)
- Testing
- Milvexian
- Where
- 1,003 sites in United States, Argentina and 42 more
- Volunteers
- 14,194 people
- Sponsor
- Janssen Research & Development, LLC
Hereditary Angioedema (HAE)
A Study of Navenibart in Participants With Hereditary Angioedema
This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2…
- Trial name
- ALPHA-ORBIT (NCT06842823)
- Testing
- navenibart
- Where
- 86 sites in United States, Australia and 22 more
- Volunteers
- 157 people
- Sponsor
- Astria Therapeutics, Inc.
Hereditary Angioedema
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
This is an open-label, multicenter extension trial to evaluate the long-term safety of KVD900 in patients who are 12 years or older with HAE type I or II.
- Trial name
- NCT05505916
- Testing
- KVD900 600 mg, KVD900 300 mg
- Where
- 71 sites in United States, Australia and 21 more
- Volunteers
- 145 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Relapsing Multiple Sclerosis
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis
The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R).
- Trial name
- NCT06847724
- Testing
- CYB704, Ocrevus-EU, Ocrevus-US
- Where
- 41 sites in United States, Bosnia and Herzegovina and 6 more
- Volunteers
- 183 people
- Sponsor
- Sandoz
Systemic Lupus Erythematosus
A Study of DS-7011a in Patients With Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a systemic chronic autoimmune disease characterized by autoantibody production, inflammation, and tissue damage in multiple organs.
- Trial name
- NCT05638802
- Testing
- DS-7011a
- Where
- 20 sites in United States, China and 2 more
- Volunteers
- 26 people
- Sponsor
- Daiichi Sankyo
Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B Cell Lymphoma (DLBCL)
GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies
The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety.
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM), Diffuse Large B Cell Lymphoma (DLBCL), Acute Myeloid Leukemia (AML)
- Trial name
- NCT04824794
- Testing
- GEN3014, Daratumumab
- Where
- 52 sites in United States, Australia and 18 more
- Volunteers
- 130 people
- Sponsor
- Genmab
Severe Hemophilia A
Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
- Trial name
- NuPOWER (NCT05935358)
- Testing
- Nuwiq
- Where
- 18 sites in United States, Croatia and 9 more
- Volunteers
- 28 people
- Sponsor
- Octapharma
Angioedema, Hereditary, Types I and II
A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
- Trial name
- KVD824-201 (NCT05055258)
- Testing
- KVD824
- Where
- 33 sites in United States, Australia and 11 more
- Volunteers
- 33 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Von Willebrand Disease
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease (VWD) Patients <6 Years of Age
The WIL-33 study aimed to determine the efficacy, pharmacokinetics, immunogenicity and safety of wilate as routine prophylaxis in up to 12 paediatric patients (eight evaluable) with severe von Willebrand Disease VWD (defined as…
- Trial name
- NCT04953884
- Testing
- Wilate
- Where
- 9 sites in United States, Czechia and 5 more
- Volunteers
- 12 people
- Sponsor
- Octapharma
Systolic Left Ventricular Dysfunction
Performance and Safety of the Cardiac Microcurrent Therapy System
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular…
- Trial name
- C-MIC-II (NCT04662034)
- Testing
- CMIC, Standard of Care (SOC)
- Where
- 20 sites in Bosnia and Herzegovina, Bulgaria and 9 more
- Volunteers
- 70 people
- Sponsor
- Berlin Heals GmbH
Chronic Obstructive Pulmonary Disease
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.
- Trial name
- PILLAR (NCT04636814)
- Testing
- CHF6001 1600µg, CHF6001 3200µg, Roflumilast
- Where
- 460 sites in United States, Argentina and 26 more
- Volunteers
- 3,973 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Dyslipidemia
- Trial name
- NCT00542386
- Testing
- MCI-196
- Where
- 73 sites in Hungary, Italy and 6 more
- Volunteers
- 642 people
- Sponsor
- Tanabe Pharma Corporation
Chronic Kidney Disease, Dialysis
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
- Conditions
- Chronic Kidney Disease, Dialysis, Hyperphosphatemia
- Trial name
- NCT00542815
- Testing
- MCI-196, Another Phosphate binder (Sevelamer)
- Where
- 115 sites in Austria, Czechia and 13 more
- Volunteers
- 632 people
- Sponsor
- Tanabe Pharma Corporation
Hereditary Angioedema, HAE
Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies
This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.
- Trial name
- APeX-A (NCT04933721)
- Testing
- berotralstat
- Where
- 16 sites in Canada, Czechia and 9 more
- Volunteers
- 139 people
- Sponsor
- BioCryst Pharmaceuticals
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.
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
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