Clinical trials: in Romania
Non Small Cell Lung Cancer
A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer
The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.
- Trial name
- JUNIPER (NCT02152631)
- Testing
- Abemaciclib, Erlotinib
- Where
- 231 sites in United States, Argentina and 19 more
- Volunteers
- 453 people
- Sponsor
- Eli Lilly and Company
Haemorrhoidal Disease
Post-Marketing Clinical Follow-Up Trial to Evaluate the Performance and Safety of PROCTOeze® PLUS
This trial aims to evaluate the overall performance and safety of the MD PROCTOeze® PLUS in relieving symptomatology of haemorrhoidal disease and anal irritation in adult patients affected by Grade I-II (Goligher classification)…
- Trial name
- NCT06944951
- Testing
- Hydrophilic emulsion for the relief of haemorroidal symptoms
- Where
- Romania
- Volunteers
- 50 people
- Sponsor
- Biokosmes Srl
Schizophrenia
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
- Trial name
- NCT03238326
- Testing
- Brexpiprazole
- Where
- 57 sites in United States, France and 8 more
- Volunteers
- 295 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Chronic Obstructive Pulmonary Disease
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.
- Trial name
- PILLAR (NCT04636814)
- Testing
- CHF6001 1600µg, CHF6001 3200µg, Roflumilast
- Where
- 460 sites in United States, Argentina and 26 more
- Volunteers
- 3,973 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Acute Cholangitis
Impact of Positive Bile Cultures on Plastic Biliary Stent Exchange
This prospective, unicenter, randomized controlled trial evaluates whether a positive bile culture at index ERCP with plastic stenting identifies patients who benefit from earlier stent exchange.
- Trial name
- TEMPEST 2 (NCT07379749)
- Testing
- stent exchange, Scheduled biliary stent exchange at one month
- Where
- Romania
- Volunteers
- 140 people
- Sponsor
- Clinical Hospital Colentina
Chronic Hepatitis B
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic…
- Trial name
- NCT01651403
- Testing
- Tenofovir DF
- Where
- 21 sites in United States, India and 3 more
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
Lupus Erythematosus, Systemic
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE).
- Trial name
- TOPAZ-2 (NCT04961567)
- Testing
- Litifilimab
- Where
- 177 sites in United States, Argentina and 15 more
- Volunteers
- 562 people
- Sponsor
- Biogen
Pneumonia, Bacterial
Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia
This is a placebo-controlled study to evaluate the addition of CAL02 to standard of care in treating hospitalized subjects diagnosed with severe community acquired bacterial pneumonia (SCABP) requiring critical care measures
- Trial name
- NCT05776004
- Testing
- CAL02
- Where
- 90 sites in United States, Argentina and 17 more
- Volunteers
- 276 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Non-small Cell Lung Cancer
A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)
The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.
- Trial name
- NCT05816252
- Testing
- SKB264, Pembrolizumab, Carboplatin
- Where
- 50 sites in China, Georgia and 4 more
- Volunteers
- 356 people
- Sponsor
- Klus Pharma Inc.
Acute Coronary Syndromes, Coronary Arterial Disease (CAD)
Focused Orticumab Research for Treating Inflammation in Coronary Arteries
The goal of this clinical trial is to determine the clinical effect of orticumab treatment on inflammation in study participants with prior myocardial infarction who have elevated coronary inflammation based on CCTA.
- Conditions
- Acute Coronary Syndromes, Coronary Arterial Disease (CAD), Inflammation, Heart Disease
- Trial name
- FORTIFY (NCT06927739)
- Testing
- Orticumab
- Where
- 41 sites in United States, Czechia and 7 more
- Volunteers
- 240 people
- Sponsor
- Abcentra
Bullying Victimisation, Bullying of Child
REThink for Mental Health of Youths in Romania
In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and…
- Conditions
- Bullying Victimisation, Bullying of Child, Bullying Behavior
- Trial name
- NCT07357363
- Testing
- REThink Intervention
- Where
- Romania
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Babes-Bolyai University
Renal Cell Carcinoma
A Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Participants With Advanced Kidney Cancer
The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.
- Trial name
- NCT03873402
- Testing
- Nivolumab, Ipilimumab
- Where
- 78 sites in United States, Argentina and 12 more
- Volunteers
- 437 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis (UC)
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of…
- Trial name
- COMMAND (NCT03398135)
- Testing
- risankizumab
- Where
- 426 sites in United States, Argentina and 41 more
- Volunteers
- 1,242 people
- Sponsor
- AbbVie
Upper Gastrointestinal Bleeding
Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy
This study will test the hypothesis that azythromycin is efficient and safe in cleansing the upper gastrointestinal tract for endoscopic examination in the case of acute bleeding.
- Trial name
- CLEAN-AZ (NCT06077916)
- Testing
- Azithromycin, Saline solution
- Where
- Romania
- Volunteers
- 224 people
- Sponsor
- Clinical Hospital Colentina
Viral Hepatitis
A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection
A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection
- Trial name
- NCT07142811
- Testing
- Tobevibart, Elebsiran, Bulevirtide
- Where
- 31 sites in Belgium, Bulgaria and 9 more
- Volunteers
- 100 people
- Sponsor
- Vir Biotechnology, Inc.
Hemolytic-Uremic Syndrome
Efficacy of INM004 in Children With STEC-HUS
The objectives of this study are to evaluate the efficacy, safety, and pharmacokinetics of INM004 in pediatric patients with Hemolytic Uremic Syndrome associated to infection by Shiga toxin-producing Escherichia coli (STEC-HUS).
- Trial name
- NCT06389474
- Testing
- INM004
- Where
- 52 sites in Argentina, Belgium and 7 more
- Volunteers
- 220 people
- Sponsor
- Inmunova S.A.
Dermatitis, Atopic
Study to Evaluate Efficacy and Safety of PF-04965842 With or Without Topical Medications in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
B7451015 is a Phase 3 study to evaluate Abrocitinib with or without Topical Medications in patients aged 12 years and older who have moderate to severe atopic dermatitis and have completed a qualifying parent study.
- Trial name
- JADE EXTEND (NCT03422822)
- Testing
- Abrocitinib 100 mg, Abrocitinib 200 mg
- Where
- 539 sites in United States, Argentina and 26 more
- Volunteers
- 3,166 people
- Sponsor
- Pfizer
Heart Failure
REGN5381 in Adult Participants With Heart Failure With Reduced Ejection Fraction
This study is researching an experimental drug called REGN5381 (called "study drug"). The study is focused on patients with heart failure with reduced ejection fraction (ie, the heart is not functioning as well as it should).
- Trial name
- NATRIX-BNP (NCT06237309)
- Testing
- REGN5381
- Where
- 44 sites in United States, Belgium and 10 more
- Volunteers
- 89 people
- Sponsor
- Regeneron Pharmaceuticals
Asthma
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered once daily over a 12-week treatment period to adult participants with moderate to severe uncontrolled…
- Trial name
- FLASH (NCT05251259)
- Testing
- Atuliflapon
- Where
- 234 sites in United States, Argentina and 18 more
- Volunteers
- 670 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04987307
- Testing
- Efavaleukin alfa
- Where
- 200 sites in United States, Argentina and 24 more
- Volunteers
- 221 people
- Sponsor
- Amgen