Clinical trials: in Romania
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
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
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
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
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.
SLE, SLE (Systemic Lupus)
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06613360
- Testing
- CLN-978
- Where
- 24 sites in United States, Australia and 7 more
- Volunteers
- 24 people
- Sponsor
- Cullinan Therapeutics Inc.
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.
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.
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
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
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
Non-Small Cell Lung Cancer
A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung…
- Trial name
- LIBRETTO-431 (NCT04194944)
- Testing
- Selpercatinib, Carboplatin, Cisplatin
- Where
- 196 sites in Argentina, Australia and 24 more
- Volunteers
- 261 people
- Sponsor
- Eli Lilly and Company
Papillary Renal Cell Carcinoma
Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell…
- Trial name
- SAMETA (NCT05043090)
- Testing
- savolitinib, durvalumab, sunitinib
- Where
- 139 sites in United States, Argentina and 23 more
- Volunteers
- 148 people
- Sponsor
- AstraZeneca
Relapsed Small Cell Lung Cancer
Clinical Trial of Lurbinectedin as Single-agent or in Combination With Irinotecan Versus Topotecan or Irinotecan in Patients With Relapsed Small-cell Lung Cancer (LAGOON)
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of lurbinectedin as single agent (Group A) or the combination of…
- Trial name
- NCT05153239
- Testing
- Irinotecan, Lurbinectedin, Topotecan
- Where
- 210 sites in United States, Australia and 22 more
- Volunteers
- 705 people
- Sponsor
- PharmaMar
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
Heart Failure
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one…
- Trial name
- Prevent-HF (NCT06677060)
- Testing
- Baxdrostat and dapagliflozin
- Where
- 977 sites in United States, Argentina and 33 more
- Volunteers
- 11,300 people
- Sponsor
- AstraZeneca
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
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
Colitis Ulcerative
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC.
- Trial name
- SPECIFI-UC (NCT06867094)
- Testing
- SAR441566
- Where
- 117 sites in United States, Argentina and 22 more
- Volunteers
- 170 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