Clinical trials: in Bosnia and Herzegovina
Chronic Kidney Diseases
Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)
This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage…
- Trial name
- Clarion-CKD (NCT04968184)
- Testing
- KBP-5074
- Where
- 215 sites in United States, Australia and 20 more
- Volunteers
- 666 people
- Sponsor
- Novo Nordisk A/S
Inflammatory Bowel Diseases, Crohn's Disease
A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's…
- Trial name
- GARNET (NCT06226883)
- Testing
- MORF-057
- Where
- 224 sites in United States, Australia and 26 more
- Volunteers
- 385 people
- Sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Arthritis, Psoriatic
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- APEX (NCT04882098)
- Testing
- Guselkumab
- Where
- 280 sites in United States, Australia and 27 more
- Volunteers
- 1,054 people
- Sponsor
- Janssen Research & Development, LLC
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation.
- Conditions
- Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Coronary Artery Disease
- Trial name
- TAILOR-DAPT (NCT05732701)
- Testing
- Algorithm-guided DAPT duration, Standard-of-care DAPT duration
- Where
- 4 sites in Bosnia and Herzegovina, Italy and 1 more
- Volunteers
- 2,788 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Crohn's Disease
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical efficacy (GALAXI 1), clinical and endoscopic efficacy (GALAXI 2 and GALAXI 3) and safety of guselkumab in participants with Crohn's disease.
- Trial name
- GALAXI (NCT03466411)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 579 sites in United States, Australia and 41 more
- Volunteers
- 1,409 people
- Sponsor
- Janssen Research & Development, LLC
Opioid Free Anesthesia, Stress Response
The Impact Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery
This study compared impact of multimodal balancing anesthesia vs opioid free anesthesia on postoperative pain intensity and stress response after open gynecology surgery.
- Conditions
- Opioid Free Anesthesia, Stress Response, Postoperative Pain
- Trial name
- NCT07138053
- Testing
- OFA group
- Where
- Bosnia and Herzegovina
- Volunteers
- 70 people
- Sponsor
- Cantonal Hospital Zenica
Multiple Sclerosis
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.
- Trial name
- NCT07503873
- Testing
- Ublituximab, Prefilled pen
- Where
- 44 sites in Bosnia and Herzegovina, Georgia and 4 more
- Volunteers
- 350 people
- Sponsor
- TG Therapeutics, Inc.
Advanced (Unresectable or Metastatic) Melanoma
Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma
This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced…
- Trial name
- NCT07221734
- Testing
- MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo®, US- sourced Opdivo®
- Where
- 86 sites in Bosnia and Herzegovina, Brazil and 11 more
- Volunteers
- 632 people
- Sponsor
- mAbxience Research S.L.
Ulcerative Colitis, Inflammatory Bowel Diseases
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Trial name
- SKYLINE-UC (NCT07012395)
- Testing
- SPY001, SPY002, SPY003
- Where
- 276 sites in United States, Argentina and 33 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.
Non-small Cell Lung Cancer Stage IV
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
- Trial name
- NCT06348199
- Testing
- SB27, Keytruda
- Where
- 93 sites in Bosnia and Herzegovina, Brazil and 12 more
- Volunteers
- 555 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Relapsing Multiple Sclerosis
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS)
The purpose of this study is to assess the pharmacokinetics of ublituximab when administered subcutaneously (SC) compared to intravenous (IV) administration in participants with RMS.
- Trial name
- NCT07211633
- Testing
- Ublituximab
- Where
- 48 sites in Bosnia and Herzegovina, Bulgaria and 7 more
- Volunteers
- 360 people
- Sponsor
- TG Therapeutics, Inc.
Carcinoma, Non-Small-Cell Lung
Pharmacokinetic Study of QL2107 Versus Keytruda® for Adjuvant Therapy of Non-Small Cell Lung Cancer (NSCLC)
The primary purpose of this study is to demonstrate Pharmacokinetic similarity in exposure after the initial dose and at steady state of QL2107 compared with Keytruda.
- Trial name
- NCT07162883
- Testing
- QL2107, Keytruda®
- Where
- 84 sites in Bosnia and Herzegovina, China and 11 more
- Volunteers
- 146 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Systemic Lupus Erythematosus (SLE), Rheumatoid Arthritis (RA)
A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases
This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid…
- Trial name
- NCT06647069
- Testing
- SAR448501
- Where
- 8 sites in Australia, Bosnia and Herzegovina and 3 more
- Volunteers
- 62 people
- Sponsor
- Sanofi
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
This is a Phase 3, randomized, double-blind, multicenter, comparative study evaluating cefepime-zidebactam (FEP-ZID) versus ceftazidime-avibactam (CAZ-AVI) with or without colistin in the treatment of adults with…
- Trial name
- NCT07885891
- Testing
- Cefepime-Zidebactam, Ceftazidime-avibactam with or without Colistin
- Where
- 55 sites in Bosnia and Herzegovina, Bulgaria and 12 more
- Volunteers
- 324 people
- Sponsor
- Wockhardt
Melanoma, Stage II, Melanoma Stage III
Assessment of PK Similarity of FYB206 in Comparison With Keytruda in Resected Stage II or III Melanoma Patients
Melanoma is a kind of skin cancer that starts in the melanocytes. Melanocytes are cells that make the pigment that gives skin its colour. 'Resected' means the melanoma has been completely removed with surgery.
- Trial name
- Dahlia (NCT06551064)
- Testing
- FYB206, Keytruda
- Where
- 17 sites in Bosnia and Herzegovina, Bulgaria and 9 more
- Volunteers
- 96 people
- Sponsor
- Formycon AG
Essential Hypertension
Monitoring the Effectiveness and Safety of Antihypertensive Therapy With a Fixed-Dose Combination of Perindopril and Amlodipine in Patients With Uncontrolled Essential Hypertension
The aim of this observational study is to monitor the effectiveness of therapy, adherence and safety of a fixed combination of perindopril + amlodipine in patients with essential hypertension.
- Trial name
- NCT07876895
- Testing
- fixed combination of perindopril + amlodipine
- Where
- Bosnia and Herzegovina
- Volunteers
- 600 people
- Sponsor
- Bosnalijek D.D
Schizophrenia, Bipolar Affective Disorder
Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder
The goal of this observational study is to evaluate the quality of life, drug safety and therapy compliance of schizophrenia or bipolar affective disorder patients during the treatment with quetiapine monotherapy or in…
- Trial name
- NCT07858565
- Testing
- Quetiapine (drug), quetiapine + aripiprazole, quetiapine + haloperidol
- Where
- Bosnia and Herzegovina
- Volunteers
- 500 people
- Sponsor
- Bosnalijek D.D
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Carcinoma, Non-Small-Cell Lung
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting.
- Trial name
- NCT03456076
- Testing
- Alectnib, Cisplatin, Vinorelbine
- Where
- 114 sites in United States, Australia and 25 more
- Volunteers
- 257 people
- Sponsor
- Hoffmann-La Roche
Diastasis Recti Abdominis (DRA), Diastasis Recti Abdominis
Manual Therapy for Diastasis Recti Abdominis
This randomized, single-blind trial compared the effects of a standardized manual therapy closure protocol, delivered alone or combined with therapeutic exercise, with therapeutic exercise alone on inter-rectus distance (IRD) in…
- Trial name
- MTDRA-RCT (NCT07861646)
- Testing
- Standardized Manual Therapy Closure Protocol, Therapeutic Exercise for Deep Abdominal Activation
- Where
- Bosnia and Herzegovina
- Volunteers
- 64 people
- Sponsor
- Studio Vita