Clinical trials: in Romania
Myelofibrosis
Clinical Epidemiology in Contemporary Patients With Myelofibrosis.
Multicenter retrospective and prospective European observational study. At each site, all consecutive patients with a 2016- or 2022 World Health Organization (WHO) confirmed diagnosis of myelofibrosis (MF) established from…
- Trial name
- ERNEST-3 (NCT06533813)
- Where
- 27 sites in Armenia, Germany and 4 more
- Volunteers
- 617 people
- Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Growth Hormone Deficiency (GHD)
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis.
- Trial name
- NCT01947907
- Testing
- ACP-001, Human Growth Hormone
- Where
- 36 sites in Belarus, Bulgaria and 12 more
- Volunteers
- 53 people
- Sponsor
- Ascendis Pharma A/S
Chronic Hepatitis B, Hepatitis B, Chronic
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as…
- Trial name
- NCT05630807
- Testing
- Bepirovirsen
- Where
- 177 sites in United States, Argentina and 24 more
- Volunteers
- 981 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
- Trial name
- SURPASS-CVOT (NCT04255433)
- Testing
- Tirzepatide, Dulaglutide
- Where
- 635 sites in United States, Argentina and 29 more
- Volunteers
- 13,299 people
- Sponsor
- Eli Lilly and Company
Chronic Hepatitis B, Hepatitis B, Chronic
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as…
- Trial name
- NCT05630820
- Testing
- Bepirovirsen
- Where
- 171 sites in United States, Argentina and 25 more
- Volunteers
- 857 people
- Sponsor
- GlaxoSmithKline
Type 2 Diabetes Mellitus
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide.
- Trial name
- REIMAGINE 2 (NCT06065540)
- Testing
- Cagrilintide, Semaglutide
- Where
- 405 sites in United States, Argentina and 30 more
- Volunteers
- 2,734 people
- Sponsor
- Novo Nordisk A/S
Tonsillar Hypertrophy, Upper Airway Obstruction
Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children
This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the…
- Trial name
- NCT06960239
- Testing
- IRE System
- Where
- 2 sites in Romania, Uzbekistan
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- ENTire Medical Ltd.
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
- Trial name
- NCT06616974
- Testing
- TX000045- Dose A, TX000045- Dose B
- Where
- 72 sites in United States, Armenia and 15 more
- Volunteers
- 191 people
- Sponsor
- Tectonic Therapeutic
Atopic Dermatitis
A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis
The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic…
- Trial name
- TRAPEDS 2 (NCT06311682)
- Testing
- Tralokinumab + TCS
- Where
- 72 sites in United States, Belgium and 11 more
- Volunteers
- 195 people
- Sponsor
- LEO Pharma
Adult Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly.
- Conditions
- Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- NCT05171855
- Testing
- Lonapegsomatropin
- Where
- 85 sites in United States, Armenia and 19 more
- Volunteers
- 220 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Ulcerative Colitis
ABTECT - Maintenance
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active…
- Trial name
- NCT05535946
- Testing
- ABX464
- Where
- 413 sites in United States, Argentina and 32 more
- Volunteers
- 1,116 people
- Sponsor
- Abivax S.A.
Early Alzheimer's Disease
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study…
- Trial name
- EVOKE (NCT04777396)
- Testing
- Semagludtide
- Where
- 447 sites in United States, Argentina and 35 more
- Volunteers
- 1,840 people
- Sponsor
- Novo Nordisk A/S
Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control.
- Conditions
- Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- foresiGHt (NCT04615273)
- Testing
- Lonapegsomatropin, Somatropin
- Where
- 113 sites in United States, Armenia and 22 more
- Volunteers
- 264 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Melanoma
A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring…
- Trial name
- NCT06153238
- Testing
- GME751, Keytruda - EU, Keytruda - US
- Where
- 61 sites in United States, Bosnia and Herzegovina and 16 more
- Volunteers
- 322 people
- Sponsor
- Sandoz
Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone)
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily.
- Conditions
- Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones
- Trial name
- NCT02781727
- Testing
- Once weekly subcutaneous injection of TransCon hGH, Once daily subcutaneous injection of Genotropin
- Where
- 53 sites in United States, Armenia and 12 more
- Volunteers
- 162 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Advanced Ovarian Cancer
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance…
- Trial name
- DUO-O (NCT03737643)
- Testing
- Bevacizumab, Durvalumab, Olaparib
- Where
- 214 sites in United States, Austria and 18 more
- Volunteers
- 1,407 people
- Sponsor
- AstraZeneca
Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
- Trial name
- POD1UM-304 (NCT04205812)
- Testing
- Retifanlimab, Pemetrexed, Cisplatin
- Where
- 140 sites in United States, Brazil and 15 more
- Volunteers
- 583 people
- Sponsor
- Incyte Corporation
Heart Failure With Reduced Ejection Fraction
A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan
The aim of this study was to describe the real-world clinical profile, treatment patterns, and guideline alignment of patients with heart failure with reduced ejection fraction (HFrEF) treated with sacubitril/valsartan in routine…
- Trial name
- REACT-HFrEF-RO (NCT07465679)
- Where
- Romania
- Volunteers
- 2,508 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Myelogenous Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Asciminib Roll-over Study
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
- Trial name
- NCT04877522
- Testing
- Asciminib single agent, Imatinib, Nilotinib
- Where
- 85 sites in United States, Argentina and 27 more
- Volunteers
- 347 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
This is a global study to assess the effects of osimertinib in participants with EGFRm stage IA2-IA3 non-small cell lung cancer following complete tumour resection.
- Trial name
- ADAURA2 (NCT05120349)
- Testing
- Osimertinib
- Where
- 139 sites in United States, Argentina and 18 more
- Volunteers
- 390 people
- Sponsor
- AstraZeneca