Clinical trials: in North Macedonia
Hip Fractures
One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures
The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures.
- Trial name
- NCT07432737
- Testing
- Tranexamic acid
- Where
- North Macedonia
- Volunteers
- 120 people
- Sponsor
- University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje
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
Adult Congenital Heart Disease, Congenital Heart Disease
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns…
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries
- Trial name
- ACHIEVE-SGLT2i (NCT06932081)
- Testing
- SGLT2 inhibitors
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 400 people
- Sponsor
- Leiden University Medical Center
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
Respiratory Infection, Lower Respiratory Tract Infection (LRTI)
Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).
The goal of this clinical trial is to assess if BUCCALIN® works In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIS). It will also evaluate the safety of BUCCALIN®.
- Trial name
- BUC-01-23 (NCT06736288)
- Testing
- BUCCALIN®
- Where
- 10 sites in Italy, North Macedonia
- Volunteers
- 240 people
- Sponsor
- Laboratorio Farmaceutico SIT srl
Hereditary Angioedema, Hereditary Angioedema Type I
Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand…
- Conditions
- Hereditary Angioedema, Hereditary Angioedema Type I, Hereditary Angioedema Type II, Hereditary Angioedema Types I and II
- Trial name
- RAPIDe-3 (NCT06343779)
- Where
- 76 sites in United States, Argentina and 27 more
- Volunteers
- 134 people
- Sponsor
- Pharvaris Netherlands B.V.
Small Cell Lung Cancer
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced…
- Trial name
- NCT02514447
- Testing
- Trilaciclib, Topotecan
- Where
- 50 sites in United States, Belgium and 6 more
- Volunteers
- 123 people
- Sponsor
- G1 Therapeutics, Inc.
Multiple Myeloma
A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma
The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously…
- Trial name
- NCT02195479
- Testing
- Velcade, Melphalan, Prednisone
- Where
- 160 sites in United States, Argentina and 22 more
- Volunteers
- 706 people
- Sponsor
- Janssen Research & Development, LLC
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Cancer Related Cardiovascular Toxicity
Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry
This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of…
- Trial name
- NCT06086132
- Testing
- Prospective validation of the HFA-ICOS risk score in a subset of subjects with newly diagnosed breast cancer and undergoing treatment with anthracyclines analogues with or without radiotherapy
- Where
- 5 sites in Italy, North Macedonia and 1 more
- Volunteers
- 10,000 people
- Sponsor
- University of Bologna
Systolic Left Ventricular Dysfunction
The C-MIC-II Follow-Up Study
The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart.
- Trial name
- C-MIC-II-FU (NCT05189860)
- Testing
- C-MIC system
- Where
- 6 sites in Bosnia and Herzegovina, Croatia and 2 more
- Volunteers
- 31 people
- Sponsor
- Berlin Heals GmbH
Hereditary Angioedema
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
This study is a randomized, double-blind, placebo-controlled, phase III, three-way crossover clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adolescent and adult…
- Trial name
- NCT05259917
- Testing
- KVD900 600 mg, KVD900 300 mg
- Where
- 66 sites in United States, Australia and 19 more
- Volunteers
- 136 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Hereditary Angioedema
A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II
This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
- Trial name
- NCT04208412
- Testing
- KVD900
- Where
- 25 sites in United States, Austria and 8 more
- Volunteers
- 84 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.