Clinical trials: in Serbia
Chronic Lymphocytic Leukemia
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
This multicenter, open-label, single-arm study will evaluate the safety and efficacy of obinutuzumab alone or in combination with chemotherapy in participants with previously untreated or relapsed/refractory chronic lymphocytic…
- Trial name
- NCT01905943
- Testing
- Bendamustine, Chlorambucil, Cyclophosphamide
- Where
- 174 sites in Argentina, Belgium and 29 more
- Volunteers
- 979 people
- Sponsor
- Hoffmann-La Roche
Community Acquired Pneumonia
Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia
- Trial name
- LEAP2 (NCT02813694)
- Testing
- lefamulin, Moxifloxacin
- Where
- 155 sites in United States, Argentina and 18 more
- Volunteers
- 738 people
- Sponsor
- Nabriva Therapeutics AG
Community Acquired Pneumonia
Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia
This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate to severe community-acquired bacterial pneumonia.
- Trial name
- LEAP (NCT02559310)
- Testing
- lefamulin, Moxifloxacin, Linezolid
- Where
- 99 sites in United States, Argentina and 16 more
- Volunteers
- 551 people
- Sponsor
- Nabriva Therapeutics AG
Coronary Artery Disease
e-NOBORI Observational Registry of Nobori DES
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
- Trial name
- e-NOBORI (NCT01261273)
- Where
- 257 sites in Austria, Bangladesh and 30 more
- Volunteers
- 18,000 people
- Sponsor
- Terumo Europe N.V.
Resistant Hypertension
Renal Sympathetic Denervation by Iberis System in Patients With Uncontrolled Hypertension - Iberis-HTN Registry
The purpose of this study is to document safety and efficacy of renal sympathetic denervation treatment in subjects with uncontrolled hypertension by using Iberis renal denervation system.
- Trial name
- Iberis (NCT02295683)
- Testing
- Renal Denervation
- Where
- 2 sites in Serbia, Spain
- Volunteers
- 18 people
- Sponsor
- Terumo Europe N.V.
Coronary Artery Disease, Angioplasty, Transluminal, Percutaneous Coronary
Safety and Efficacy Study of Kaname Coronary Stent System for the Treatment of Patients With Coronary Artery Disease
The purpose of this study is to assess whether the new Kaname coronary stent is safe and effective for the treatment of patients with coronary artery disease.
- Trial name
- KARE (NCT01004575)
- Testing
- implantation of Kaname Cobalt-Chromium coronary stent
- Where
- 17 sites in France, Germany and 3 more
- Volunteers
- 282 people
- Sponsor
- Terumo Europe N.V.
Adult Growth Hormone Deficiency
MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)
This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4…
- Trial name
- NCT01225666
- Testing
- MOD-4023
- Where
- 15 sites in Czechia, Hungary and 4 more
- Volunteers
- 52 people
- Sponsor
- OPKO Health, Inc.
Coronary Artery Disease
Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry
The e-Ultimaster will further validate the safety and efficacy of Ultimaster DES system in unselected patients representing everyday clinical practice.
- Trial name
- e-Ultimaster (NCT02188355)
- Where
- 462 sites in Argentina, Armenia and 48 more
- Volunteers
- 37,000 people
- Sponsor
- Terumo Europe N.V.
Epidermolysis Bullosa
Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa
The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).
- Trial name
- NCT02670330
- Testing
- SD-101-6.0 cream
- Where
- 30 sites in United States, Australia and 10 more
- Volunteers
- 152 people
- Sponsor
- Scioderm, Inc.
Coronary Artery Disease
FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
The overall purpose of the FAME II trial is to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease.
- Trial name
- NCT01132495
- Testing
- Stenting plus OMT, OMT, Standard of care
- Where
- 29 sites in United States, Belgium and 11 more
- Volunteers
- 1,170 people
- Sponsor
- Abbott Medical Devices
Acute Myeloid Leukemia
Trial of Decitabine in Patients With Acute Myeloid Leukemia
The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of…
- Trial name
- NCT00260832
- Testing
- Cytarabine or Supportive Care, Dacogen (decitabine) only
- Where
- 108 sites in United States, Australia and 13 more
- Volunteers
- 485 people
- Sponsor
- Eisai Inc.
Stroke, Secondary Prevention
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months.
- Trial name
- NCT02239120
- Testing
- optional ASA as comedication, ASA 100 mg
- Where
- 569 sites in United States, Argentina and 40 more
- Volunteers
- 5,390 people
- Sponsor
- Boehringer Ingelheim
Lymphoma, Malignant
Open-Label, Non Randomized Phase 2 Study With Safety Run-In
The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of bimiralisib (PQR309) administered orally, as once daily capsules…
- Trial name
- NCT02249429
- Testing
- bimiralisib
- Where
- 12 sites in United States, Bosnia and Herzegovina and 4 more
- Volunteers
- 53 people
- Sponsor
- PIQUR Therapeutics AG
Clostridium Difficile Infection
Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI)
The purpose of this study is to determine the safe use and evaluate the efficacy/performance of DAV132 in hospitalized patients at high risk for Clostridium difficile infection (CDI) and who receive fluoroquinolones (FQs) for the…
- Trial name
- SHIELD (NCT03710694)
- Testing
- DAV132
- Where
- 29 sites in Bulgaria, Germany and 2 more
- Volunteers
- 260 people
- Sponsor
- Da Volterra
Crohn Disease
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks.
- Trial name
- NCT02596893
- Testing
- GED-0301
- Where
- 538 sites in United States, Australia and 33 more
- Volunteers
- 701 people
- Sponsor
- Celgene
Rheumatoid Arthritis
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX…
- Trial name
- NCT02309359
- Testing
- ALX-0061, Methotrexate
- Where
- 94 sites in United States, Belgium and 12 more
- Volunteers
- 345 people
- Sponsor
- Ablynx, a Sanofi company
Rheumatoid Arthritis
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
The primary objective of this study is: To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).
- Trial name
- NCT02287922
- Testing
- ALX-0061, Tocilizumab
- Where
- 83 sites in United States, Belgium and 12 more
- Volunteers
- 251 people
- Sponsor
- Ablynx, a Sanofi company
Chronic Renal Anemia
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not…
- Trial name
- NCT00773513
- Testing
- Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta
- Where
- 196 sites in Argentina, Australia and 25 more
- Volunteers
- 2,825 people
- Sponsor
- Hoffmann-La Roche
Acute Heart Failure, Congestive Heart Failure
Clinical Evaluation of the TRVD™ System in ADHF
A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and…
- Conditions
- Acute Heart Failure, Congestive Heart Failure, Heart Failure, Congestive
- Trial name
- TRVD (NCT03621436)
- Testing
- TRVD Therapy
- Where
- 3 sites in Belgium, Croatia and 1 more
- Volunteers
- 13 people
- Sponsor
- Magenta Medical Ltd.
Immune Thrombocytopenia
This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)
The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response.
- Trial name
- NCT02859909
- Testing
- BT595
- Where
- 22 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 34 people
- Sponsor
- Biotest
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