Clinical trials: in Romania
Untreated, Unresectable, or Metastatic Colorectal Cancer
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or…
- Trial name
- NCT07221357
- Testing
- Pumitamig, FOLFOX, FOLFIRI
- Where
- 286 sites in United States, Argentina and 23 more
- Volunteers
- 990 people
- Sponsor
- Bristol-Myers Squibb
Acromegaly
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison…
- Trial name
- OXTEND™-03 (NCT06930625)
- Testing
- Debio 4126
- Where
- 74 sites in United States, Austria and 19 more
- Volunteers
- 119 people
- Sponsor
- Debiopharm International SA
Non-Small Cell Lung Cancer (NSCLC)
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum…
- Trial name
- NCT05920356
- Testing
- Sotorasib, Pembrolizumab
- Where
- 424 sites in United States, Argentina and 36 more
- Volunteers
- 750 people
- Sponsor
- Amgen
Breast Cancer; HER2-positive; Metastatic
Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)
The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2…
- Trial name
- NCT04784715
- Testing
- Trastuzumab deruxtecan, Taxane, Pertuzumab
- Where
- 283 sites in United States, Argentina and 25 more
- Volunteers
- 1,157 people
- Sponsor
- AstraZeneca
Bladder Cancer, Urothelial Carcinoma
A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
This Phase 3, single-arm, multicenter study was designed to evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with recurrent low-grade intermediate-risk…
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Urothelial Carcinoma Bladder
- Trial name
- UTOPIA (NCT06331299)
- Testing
- UGN-103
- Where
- 48 sites in United States, Bulgaria and 5 more
- Volunteers
- 99 people
- Sponsor
- UroGen Pharma Ltd.
Chronic Primary Immune Thrombocytopenia (ITP)
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
The purpose of this study is to evaluate the efficacy and safety of KIg 10 (Intravenous Immunoglobulin 10%) in adult patients with chronic primary ITP
- Trial name
- ITP (NCT07059000)
- Testing
- Kedrion IVIG 10%
- Where
- 28 sites in United States, Czechia and 6 more
- Volunteers
- 40 people
- Sponsor
- Kedrion S.p.A.
Achondroplasia
Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia
This is a multicenter, multinational, randomized, active-controlled, operationally seamless Phase 2/3 study of BMN 333 in treatment-naïve pediatric participants with achondroplasia (ACH).
- Trial name
- ASPEN (NCT07441876)
- Testing
- BMN 333, Vosoritide Injection [Voxzogo]
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 160 people
- Sponsor
- BioMarin Pharmaceutical
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
InRAD Observational Study
The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across…
- Conditions
- Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), Non-Alzheimer Degenerative Dementia
- Trial name
- InRAD (NCT07213700)
- Testing
- None, this is a non-interventional observational study
- Where
- 23 sites in Australia, Austria and 15 more
- Volunteers
- 50,000 people
- Sponsor
- Stichting International Registry for Alzheimer's Disease and other Dementias Foundation
Lymphedema, Breast Cancer
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization…
- Trial name
- LYMPH (NCT05890677)
- Testing
- Surgical Intervention, Conservative Complex Physical Decongestion Therapy
- Where
- 36 sites in United States, Austria and 13 more
- Volunteers
- 280 people
- Sponsor
- University Hospital, Basel, Switzerland
Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma
Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous…
- Trial name
- firmMIND (NCT05429268)
- Testing
- Tafasitamab, Lenalidomide
- Where
- 61 sites in Bulgaria, Croatia and 12 more
- Volunteers
- 82 people
- Sponsor
- Incyte Corporation
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.
Severe Asthma
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.
- Trial name
- NCT07276724
- Testing
- GB-0895
- Where
- 134 sites in United States, Brazil and 15 more
- Volunteers
- 786 people
- Sponsor
- Generate Biomedicines
Cancer
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during…
- Trial name
- IMbrella B (NCT03768063)
- Testing
- Atezolizumab, Bevacizumab, Alectinib
- Where
- 80 sites in United States, Australia and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Hoffmann-La Roche
Venous Thromboembolism (VTE)
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2.
- Trial name
- ROXI-CAT-II (NCT07493304)
- Testing
- REGN7508, Apixaban
- Where
- 13 sites in United States, Bulgaria and 3 more
- Volunteers
- 1,600 people
- Sponsor
- Regeneron Pharmaceuticals
Generalized Myasthenia Gravis
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)
The purpose of this clinical study is to determine the efficacy and safety of a new oral cladribine formulation in participants with Generalized Myasthenia Gravis (gMG) in comparison to placebo.
- Trial name
- NCT06463587
- Testing
- Cladribine Low Dose, Cladribine High Dose
- Where
- 154 sites in United States, Argentina and 23 more
- Volunteers
- 264 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups.
- Trial name
- CEREN-2 (NCT06834360)
- Testing
- Itepekimab (SAR440340), Mometasone furoate nasal spray (MFNS)
- Where
- 111 sites in United States, Argentina and 21 more
- Volunteers
- 216 people
- Sponsor
- Sanofi
GERD (Gastroesophageal Reflux Disease)
A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)
The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication.
- Trial name
- NCT07037875
- Testing
- Linaprazan glurate 50 mg Twice Daily (BID), Linaprazan Glurate 50 mg Once Daily (QD), Lansoprazole 30 mg Once Daily (QD)
- Where
- 87 sites in Bulgaria, Czechia and 6 more
- Volunteers
- 523 people
- Sponsor
- Cinclus Pharma Holding AB
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
Ulcerative Colitis (UC), Severe Ulcerative Colitis
A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis
The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body…
- Conditions
- Ulcerative Colitis (UC), Severe Ulcerative Colitis, Moderate Ulcerative Colitis
- Trial name
- ASCENTRA-UC (NCT07845487)
- Testing
- PALI-2108
- Where
- 115 sites in United States, Canada and 10 more
- Volunteers
- 204 people
- Sponsor
- Palisade Bio
Diffuse Large B-Cell Lymphoma
A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)
The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.
- Trial name
- NCT06717347
- Testing
- Zilovertamab vedotin, Rituximab, Cyclophosphamide
- Where
- 285 sites in United States, Argentina and 33 more
- Volunteers
- 1,046 people
- Sponsor
- Merck Sharp & Dohme LLC
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