Clinical trials: in Belarus
Ischemia-reperfusion Injury in Liver Transplant, Early Allograft Dysfunction
Pilot Study of Reparixin for Early Allograft Dysfunction Prevention in Liver Transplantation
The objective of the study is to evaluate the efficacy and safety of Reparixin treatment (2.772 mg/kg body weight/hour intravenous continuous infusion for 7 days) based on incidence of early allograft dysfunction within the first…
- Trial name
- NCT03031470
- Testing
- Reparixin, Control
- Where
- 7 sites in Belarus, Russia
- Volunteers
- 40 people
- Sponsor
- Dompé Farmaceutici S.p.A
Lung Cancer, Non-small Cell Lung Cancer
A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
- Trial name
- NCT02754882
- Testing
- Bevacizumab, SB8, Carboplatin
- Where
- 105 sites in Belarus, Georgia and 11 more
- Volunteers
- 763 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Clinical study to examine the safety, tolerability and efficacy of long-term combination therapy of tamsulosin and solifenacin in the treatment of males with lower urinary tract symptoms (LUTS) associated with benign prostatic…
- Trial name
- Neptune II (NCT01021332)
- Testing
- tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg), tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
- Where
- 70 sites in Austria, Belarus and 9 more
- Volunteers
- 1,067 people
- Sponsor
- Astellas Pharma Europe B.V.
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS…
- Trial name
- Neptune (NCT01018511)
- Testing
- tamsulosin hydrochloride OCAS 0.4 mg, tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg)
- Where
- 118 sites in Austria, Belarus and 11 more
- Volunteers
- 1,334 people
- Sponsor
- Astellas Pharma Europe B.V.
Primary IgA Nephropathy
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy
The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal…
- Trial name
- Nefigard (NCT03643965)
- Testing
- Nefecon
- Where
- 142 sites in United States, Argentina and 17 more
- Volunteers
- 365 people
- Sponsor
- Calliditas Therapeutics AB
Urologic Diseases, Urinary Bladder, Overactive
A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of…
- Conditions
- Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases
- Trial name
- BEYOND (NCT01638000)
- Testing
- Mirabegron, Solifenacin succinate
- Where
- 217 sites in Armenia, Austria and 31 more
- Volunteers
- 1,887 people
- Sponsor
- Astellas Pharma Europe Ltd.
Urinary Bladder, Overactive
Study to Test the Long Term Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active…
- Trial name
- TAURUS (NCT00688688)
- Testing
- Mirabegron, Tolterodine
- Where
- 308 sites in United States, Australia and 28 more
- Volunteers
- 2,792 people
- Sponsor
- Astellas Pharma Inc
Urinary Bladder, Overactive
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
The study is intended to test efficacy, safety and tolerability of two doses of Mirabegron against placebo and compare the efficacy and safety with active comparator in patients with symptoms of overactive bladder.
- Trial name
- SCORPIO (NCT00689104)
- Testing
- Mirabegron, Tolterodine
- Where
- 218 sites in Australia, Austria and 28 more
- Volunteers
- 2,336 people
- Sponsor
- Astellas Pharma Inc
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease Patients Not Requiring Dialysis
This study was conducted to treat anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin is important for the transport of oxygen in your blood.
- Trial name
- ALPS (NCT01887600)
- Testing
- Roxadustat
- Where
- 138 sites in Belarus, Belgium and 20 more
- Volunteers
- 594 people
- Sponsor
- Astellas Pharma Europe B.V.
Anemia in Chronic Kidney Disease in Non-dialysis Patients
Roxadustat in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa
The primary objective of this study was to evaluate the efficacy of roxadustat compared to darbepoetin alfa in the treatment of anemia in nondialysis-dependent chronic kidney disease (NDD CKD) participants.
- Trial name
- Dolomites (NCT02021318)
- Testing
- Roxadustat, Darbepoetin alfa
- Where
- 125 sites in Austria, Belarus and 24 more
- Volunteers
- 616 people
- Sponsor
- Astellas Pharma Europe B.V.
HER2 Positive Breast Cancer
A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients
In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
- Trial name
- TROIKA (NCT03013504)
- Testing
- HD201, Herceptin, Docetaxel
- Where
- 15 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 503 people
- Sponsor
- Prestige Biopharma Limited
Liver Transplantation
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
- Trial name
- DIAMOND (NCT01011205)
- Testing
- Advagraf, Mycophenolate Mofetil, Basiliximab
- Where
- 72 sites in Argentina, Austria and 21 more
- Volunteers
- 893 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplantation
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
- Trial name
- ADHERE (NCT01363752)
- Testing
- Advagraf, Mycophenolate Mofetil, Sirolimus
- Where
- 58 sites in Australia, Austria and 15 more
- Volunteers
- 853 people
- Sponsor
- Astellas Pharma Inc
Urologic Diseases, Urinary Bladder Diseases
A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder
The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.
- Conditions
- Urologic Diseases, Urinary Bladder Diseases, Urological Manifestations, Signs and Symptoms
- Trial name
- Symphony (NCT01340027)
- Testing
- Mirabegron, Solifenacin succinate
- Where
- 133 sites in Belarus, Belgium and 18 more
- Volunteers
- 1,307 people
- Sponsor
- Astellas Pharma Europe B.V.
Liver Transplant, Kidney Transplant
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients.
- Trial name
- ADDRESS (NCT02057484)
- Testing
- Tacrolimus
- Where
- 145 sites in Austria, Belarus and 22 more
- Volunteers
- 2,300 people
- Sponsor
- Astellas Pharma Europe Ltd.
Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
To determine the safety and descriptive efficacy of dalbavancin for the treatment of acute bacterial skin and skin structure infections in children, aged birth to 17 years (inclusive), known or suspected to be caused by…
- Conditions
- Methicillin-Resistant Staphylococcus Aureus, Bacterial Infections, Staphylococcal Skin Infections
- Trial name
- NCT02814916
- Testing
- Dalbavancin, Vancomycin, Oxacillin
- Where
- 84 sites in United States, Argentina and 18 more
- Volunteers
- 199 people
- Sponsor
- AbbVie
Refractory Metastatic Gastric Cancer
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer
The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer.
- Trial name
- NCT02500043
- Testing
- TAS-102
- Where
- 139 sites in United States, Belarus and 16 more
- Volunteers
- 507 people
- Sponsor
- Taiho Oncology, Inc.
Acute Myeloid Leukemia
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML
The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed AML.
- Trial name
- NCT05272293
- Testing
- NK cell infusions
- Where
- Belarus
- Volunteers
- 15 people
- Sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
B-cell Acute Lymphoblastic Leukemia, Lymphoblastic B-Cell Lymphoma
Pilot CAR-T Cells Therapy for Children/Young Adults With CD19+ R/R Leukemia/Lymphoma
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
- Trial name
- NCT05333302
- Testing
- CD19 CAR-T-cells, Tocilizumab
- Where
- Belarus
- Volunteers
- 10 people
- Sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Acute Myeloid Leukemia
Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.
- Trial name
- NCT05334693
- Testing
- Expanded haploidentical NK cells
- Where
- Belarus
- Volunteers
- 15 people
- Sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology