Clinical trials: in Romania
Chronic Kidney Disease, Renal Anemia
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Roxadustat is a licensed medicine to treat anemia in adults with chronic kidney disease (CKD). Anemia is a low level of red blood cells.
- Trial name
- NCT05970172
- Testing
- Roxadustat
- Where
- 47 sites in Belgium, Croatia and 17 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored…
- Trial name
- NCT02960022
- Testing
- enzalutamide, abiraterone acetate, prednisone
- Where
- 233 sites in United States, Argentina and 36 more
- Volunteers
- 900 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pulmonary Arterial Hypertension
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
- Trial name
- NCT06274801
- Testing
- Seralutinib, Gereic Dry Powder Inhaler
- Where
- 120 sites in United States, Argentina and 28 more
- Volunteers
- 330 people
- Sponsor
- Gossamer Bio USA, Inc.
Lennox Gastaut Syndrome
An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with…
- Trial name
- NCT05066217
- Testing
- Clemizole HCl
- Where
- 71 sites in United States, China and 8 more
- Volunteers
- 260 people
- Sponsor
- Epygenix
Early Breast Cancer
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals
CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people…
- Trial name
- XPERT (NCT07540221)
- Testing
- Gamunex-C, Xembify
- Where
- 15 sites in United States, Czechia and 2 more
- Volunteers
- 40 people
- Sponsor
- Grifols Therapeutics LLC
Non-small Cell Lung Cancer (NSCLC)
Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)
This is a Phase 1b/2 study evaluating the anti-PD1 antibody, cemiplimab, in combination with either S095018 (anti-TIM3 antibody), S095024 (anti-CD73 antibody), or S095029 (anti-NKG2A antibody) in adult participants with…
- Trial name
- NCT06162572
- Testing
- S095018, S095024, S095029
- Where
- 52 sites in United States, Australia and 11 more
- Volunteers
- 102 people
- Sponsor
- Servier Bio-Innovation LLC
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Venous Leg Ulcer (VLU)
A Double Blind Study Performed to Evaluate the Efficacy and the Safety of EscharEx in Debridement of VLU (VALUE)
The main objective of this study is: To assess the efficacy and safety of EscharEx (EX-03 5% formulation) compared to placebo control,in debridement and wound bed preparation of Venous Leg Ulcers (VLU).
- Trial name
- VALUE (NCT06568627)
- Testing
- EscharEx (EX-03)
- Where
- 60 sites in United States, Austria and 7 more
- Volunteers
- 216 people
- Sponsor
- MediWound Ltd
Arthritis, Psoriatic
Evaluation of Sonelokimab in Patients With Active Psoriatic Arthritis Naive to Biologic Disease-Modifying Antirheumatic Drug
This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic…
- Trial name
- IZAR-1 (NCT06641076)
- Testing
- Sonelokimab
- Where
- 182 sites in United States, Bulgaria and 18 more
- Volunteers
- 960 people
- Sponsor
- MoonLake Immunotherapeutics AG
Ulcerative Colitis, Crohn's Disease
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time.
- Trial name
- NCT06405087
- Testing
- Vedolizumab SC, No Intervention
- Where
- 47 sites in United States, Belgium and 12 more
- Volunteers
- 70 people
- Sponsor
- Takeda
Lung Cancer, Hepatocellular Carcinoma
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
This is a non-interventional, multi-country, multi-centre, multicohort, primary data collection study, designed to assess patients' reported satisfaction with Atezolizumab Subcutenous (SC) treatment and Health-related Quality of…
- Trial name
- NCT07284121
- Testing
- Atezolizumab
- Where
- 92 sites in Austria, Belgium and 6 more
- Volunteers
- 700 people
- Sponsor
- Hoffmann-La Roche
Clostridioides Difficile Infection
Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response…
- Trial name
- Ri-CoDIFy 1 (NCT03595553)
- Testing
- Ridinilazole, Vancomycin
- Where
- 149 sites in United States, Argentina and 12 more
- Volunteers
- 759 people
- Sponsor
- Summit Therapeutics
Psoriasis (PsO), Psychological Distress
Online Therapist-guided Receptive Music Therapy in Adults With Psoriasis
This single-center, three-arm randomized controlled trial evaluated a four-week online therapist-guided receptive music therapy program as an adjunct to treatment as usual in adults with moderate-to-severe psoriasis and…
- Conditions
- Psoriasis (PsO), Psychological Distress, Depressive Symptom, Anxiety
- Trial name
- RePSO (NCT05894759)
- Testing
- Therapist-guided receptive music therapy, Audio-based active relaxation control
- Where
- Romania
- Volunteers
- 75 people
- Sponsor
- Grigore T. Popa University of Medicine and Pharmacy
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
- Trial name
- JOURNEY (NCT06878261)
- Testing
- Tezepelumab
- Where
- 284 sites in United States, Argentina and 20 more
- Volunteers
- 990 people
- Sponsor
- AstraZeneca
Non-Small Cell Lung Cancer
Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)
A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy
- Trial name
- NCT07100080
- Testing
- Iza-bren, Carboplatin, Cisplatin
- Where
- 187 sites in United States, Argentina and 23 more
- Volunteers
- 500 people
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis (RA)
A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [Proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis
A study to compare efficacy, pharmacokinetics, safety and immunogenicity of MB04 [proposed etanercept biosimilar] to Enbrel® [EU-sourced] in rheumatoid arthritis
- Trial name
- NCT06596772
- Testing
- MB04 (proposed biosimilar to etanercept), Enbrel (etanercept)
- Where
- 60 sites in Bulgaria, Georgia and 4 more
- Volunteers
- 501 people
- Sponsor
- mAbxience Research S.L.
Metabolic Dysfunction-Associated Steatotic Liver Disease
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease…
- Trial name
- NCT07165028
- Testing
- Tirzepatide, Retatrutide
- Where
- 563 sites in United States, Argentina and 32 more
- Volunteers
- 4,500 people
- Sponsor
- Eli Lilly and Company
NSCLC
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in…
- Trial name
- ReAlec (NCT04764188)
- Testing
- Alectinib
- Where
- 116 sites in Argentina, Australia and 23 more
- Volunteers
- 800 people
- Sponsor
- Hoffmann-La Roche
Lymphoma, Mantle Cell
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.
- Trial name
- NCT02972840
- Testing
- Acalabrutinib, Bendamustine, Rituximab
- Where
- 228 sites in United States, Argentina and 25 more
- Volunteers
- 635 people
- Sponsor
- Acerta Pharma BV
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