Clinical trials: in Romania
Hematologic Malignancies, Waldenstroms Macroglobulinaemia
Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's…
- Conditions
- Hematologic Malignancies, Waldenstroms Macroglobulinaemia, Non-Hodgkins Lymphoma, Chronic Lymphocytic Leukaemia
- Trial name
- NCT04728893
- Testing
- Nemtabrutinib
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 490 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Myocardial Infarction
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
- Trial name
- SOS-AMI (NCT04957719)
- Testing
- Selatogrel
- Where
- 872 sites in United States, Australia and 45 more
- Volunteers
- 25,000 people
- Sponsor
- Viatris Innovation GmbH
Hypertension
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
This study is to evaluate the long-term safety, efficacy and tolerability of lorundrostat (an aldosterone synthase inhibitor) in subjects with hypertension
- Trial name
- NCT05968430
- Testing
- lorundrostat
- Where
- 177 sites in United States, Australia and 11 more
- Volunteers
- 1,076 people
- Sponsor
- Mineralys Therapeutics Inc.
Moderate to Severe Crohn's Disease
Phase IIa Study Evaluating AZD7798 in Crohn's Disease
This is a randomised, double-blind, parallel group, placebo-controlled Phase IIa study designed to evaluate the efficacy and safety of AZD7798 in participants with moderate to severe Crohn's disease.
- Trial name
- AMALTHEA (NCT06450197)
- Testing
- AZD7798
- Where
- 116 sites in United States, Argentina and 24 more
- Volunteers
- 120 people
- Sponsor
- AstraZeneca
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Master Framework For Relapse or Refractory Acute Myeloid Leukemia
This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites
- Trial name
- IMPACT STREAM (NCT06459024)
- Testing
- Registration into the STREAM platform
- Where
- 41 sites in Germany, Italy and 5 more
- Volunteers
- 4,000 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Alzheimer Disease
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.
- Trial name
- NCT06585787
- Testing
- KarXT
- Where
- 296 sites in United States, Argentina and 23 more
- Volunteers
- 406 people
- Sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Acute Myeloid Leukemia, Relapse/Recurrence
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia.
- Trial name
- IMPACT-AML (NCT06713837)
- Testing
- High intensity therapies, Low intensity therapies
- Where
- 51 sites in Czechia, Germany and 6 more
- Volunteers
- 339 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Non Small Cell Lung Carcinoma, c-MET
Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide.
- Trial name
- NCT06772623
- Testing
- Telisotuzumab Adizutecan, Budigalimab, Pembrolizumab
- Where
- 127 sites in United States, Argentina and 15 more
- Volunteers
- 252 people
- Sponsor
- AbbVie
Carcinoma, Non-Small-Cell Lung
A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with…
- Trial name
- NCT06875310
- Testing
- Adagrasib, Pembrolizumab, Carboplatin
- Where
- 317 sites in United States, Argentina and 33 more
- Volunteers
- 630 people
- Sponsor
- Mirati Therapeutics Inc.
Alzheimer's Disease
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
- Trial name
- MINDSET 1 (NCT06976216)
- Testing
- KarXT, KarX-EC
- Where
- 119 sites in United States, Argentina and 17 more
- Volunteers
- 586 people
- Sponsor
- Bristol-Myers Squibb
Plaque Psoriasis
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis
- Trial name
- POETYK-PsO-Ped (NCT06979453)
- Testing
- Deucravacitinib
- Where
- 133 sites in United States, Argentina and 14 more
- Volunteers
- 366 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis, Inflammatory Bowel Diseases
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Trial name
- SKYLINE-UC (NCT07012395)
- Testing
- SPY001, SPY002, SPY003
- Where
- 276 sites in United States, Argentina and 33 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.
Multiple Sclerosis (MS) Primary Progressive
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS.
- Trial name
- NCT07067463
- Testing
- Orelabrutinib
- Where
- 76 sites in United States, Bulgaria and 14 more
- Volunteers
- 705 people
- Sponsor
- Zenas BioPharma (USA), LLC
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6…
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Trial name
- emnergize (NCT07091630)
- Testing
- Empasiprubart IV
- Where
- 89 sites in United States, Argentina and 23 more
- Volunteers
- 160 people
- Sponsor
- argenx
Acute Ischemic Stroke
A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke).
- Trial name
- TENACITY (NCT07361302)
- Testing
- Tenecteplase, Standard of care treatment
- Where
- 257 sites in Argentina, Australia and 14 more
- Volunteers
- 1,325 people
- Sponsor
- Boehringer Ingelheim
Solid Tumors
A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer…
- Trial name
- NCT07415031
- Testing
- Adagrasib, Pembrolizumab, Cetuximab
- Where
- 101 sites in United States, Australia and 19 more
- Volunteers
- 170 people
- Sponsor
- Mirati Therapeutics Inc.
Chronic Hepatitis D
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).
- Trial name
- NCT07454837
- Testing
- Brelovitug (BJT-778), Bulevirtide
- Where
- 46 sites in Austria, Czechia and 6 more
- Volunteers
- 120 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Hypertension, Pulmonary, Lung Diseases, Interstitial
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
The primary purpose of this study is to assess the effect of TX000045 on pulmonary vascular resistance (PVR) in participants with pulmonary hypertension secondary to interstitial lung disease (PH-ILD) and to assess the safety and…
- Trial name
- NCT07473700
- Testing
- TX000045
- Where
- 16 sites in United States, Poland and 4 more
- Volunteers
- 25 people
- Sponsor
- Tectonic Operating Company, Inc.
Graves Disease
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease.
The main purpose of this study is to look at how efgartigimod affects thyroid function in adults with Graves' Disease (GD). The study will also check whether efgartigimod is safe and well tolerated.
- Trial name
- VitaliThy (NCT07596849)
- Testing
- efgartigimod PH20 SC
- Where
- 42 sites in Belgium, Bulgaria and 10 more
- Volunteers
- 230 people
- Sponsor
- argenx
Ulcerative Colitis, Inflammatory Bowel Diseases
Long-term Safety and Efficacy of Multiple Long-acting Antibodies Alone and in Combinations for IBD
This is a multicenter, long-term extension (LTE) study in participants with ulcerative colitis (UC) from Study SPY123-201 (The SKYLINE-UC study).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Trial name
- SKYLINE-LTE (NCT07652294)
- Testing
- SPY001, SPY002, SPY003
- Where
- 91 sites in United States, Argentina and 21 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.