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Намерени 3,079 изпитвания Стр. 135 от 154

Активно (без набиране) Фаза 1/2

Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to Prostatectomy

Prostatic Neoplasms

This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)

Начало: 06.08.2020 Край: 30.08.2025 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT04430192

Активно (без набиране) Фаза 1

A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma

Advanced Renal Cell Carcinoma

The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or Axitinib), in subjects with advanced renal cell carcinoma.

Начало: 05.08.2020 Край: 26.09.2025 Възраст: 18–101 г. Лечение

Australia, France, Spain +1 MedImmune LLC NCT04522323

Активно (без набиране) Фаза 1

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Non-Small Cell Lung Cancer Colorectal Cancer Advanced Solid Tumors

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Начало: 29.07.2020 Край: 31.12.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +14 Genentech, Inc. NCT04449874

Активно (без набиране) Фаза 3

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial

SARS-CoV-2 Infection (COVID-19)

An International Multi-Centre Randomised Adaptive Platform Clinical Trial to Assess the Clinical, Virological and Immunological Outcomes in Patients with SARS-CoV-2 Infection (COVID-19).

Начало: 28.07.2020 Край: 31.12.2025 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT04483960

Активно (без набиране)

Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA

Advanced Degeneration of the Hip Joint Revision of the Hip Joint

The purpose of this study is to assess the safety and effectiveness of the OR3O™ Dual Mobility System. The study will evaluate the outcome of the Total Hip Arthroplasty using the OR3O™ Dual Mobility System over a ten year period. Survivorship of THA will be assessed up to ten years.

Начало: 27.07.2020 Край: 31.01.2035 Възраст: 18–80 г.

Australia, Canada, Hong Kong +1 Smith & Nephew, Inc. NCT04325022

Активно (без набиране) Фаза 3

Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Advanced or Metastatic Breast Cancer

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Начало: 24.07.2020 Край: 19.06.2026 Възраст: 18–105 г. Лечение

Argentina, Australia, Belgium +22 AstraZeneca NCT04494425

Активно (без набиране) Фаза 2

Ivosidenib in Treating Patients With Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With IDH1 Mutations (A Pediatric MATCH Treatment Trial)

Recurrent Ependymoma Recurrent Ewing Sarcoma Recurrent Hepatoblastoma Recurrent Langerhans Cell Histiocytosis +29

This phase II Pediatric MATCH trial studies how well ivosidenib works in treating patients with solid tumors, including central nervous system tumors, lymphomas and histiocytic disorders that have not responded to (refractory) or have come back after (recurrent) prior treatment that have IDH (isocitrate dehydrogenase) 1 genetic alterations (mutations). Ivosidenib may block the growth of cancer cells that have specific genetic changes in an important signaling pathway called the IDH pathway.

Начало: 20.07.2020 Край: 09.05.2026 Възраст: 12–21 г. Лечение

Australia, Puerto Rico, United States National Cancer Institute (NCI) NCT04195555

Активно (без набиране) Фаза 3

AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid

Preclinical Alzheimer's Disease Early Preclinical Alzheimer's Disease

The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). This study will also evaluate the long-term safety and tolerability of lecanemab in participants enrolled in the Extension Phase.

Начало: 14.07.2020 Край: 16.01.2031 Възраст: 55–80 г. Лечение

Australia, Canada, Japan +4 Eisai Inc. NCT04468659

Активно (без набиране) Фаза 3

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

Hormone-Sensitive Prostate Cancer

This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

Начало: 13.07.2020 Край: 29.03.2027 Възраст: 18–130 г. Лечение

Argentina, Australia, Belgium +28 AstraZeneca NCT04493853

Активно (без набиране) Фаза 3

A Study to Compare Safety and Efficacy of High Doses of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

Muscular Dystrophy, Duchenne

Part 1 (dose escalation) will evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram \[mg/kg\] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will evaluate the efficacy and safety of the high doses (100 mg/kg and 200 mg/kg) of eteplirsen compared with that of the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.

Начало: 13.07.2020 Край: 31.10.2026 Възраст: 4–13 г. Лечение

Colombia, Czechia, Denmark +22 Sarepta Therapeutics, Inc. NCT03992430

Активно (без набиране)

Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia

Heart Disease Structural Disorder Ventricular Tachycardia Cardiomyopathy, Dilated Sarcoidosis +5

Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important clinical sequela in patients with structural heart disease. VT generally occurs as a result of electrical re-entry in the presence of arrhythmogenic substrate (scar). Scar tissue forms due to an ischemic cardiomyopathy (ICM) from prior coronary obstructive disease or a non-ischemic cardiomyopathy (NICM) from an inflammatory or genetic disease. AADs can reduce VT recurrence, but have significant limitations in treatment of VT. For example, amiodarone has high rates of side effects/toxicities and a finite effective usage before recurrence. ICDs prevent cardiac arrest and sudden death from VT, but do not stop VT occurring. Recurrent VT and ICD therapies decrease QOL, increase hospital visits, mortality, morbidity and risk of death. Improvement in techniques for mapping and ablation of VT have made CA an alternative. Currently, there is limited evidence to guide clinicians either toward AAD therapy or CA in patients with NICM. This data shows significant benefit of CA over medical therapy in terms of VT free survival, survival free of VT storm and VT burden. Observational studies suggest that CA is effective in eliminating VT in NICM patients who have failed AADs, resulting in reduction of VT burden and AAD use over long term follow up. Furthermore, there is limited data on the efficacy of CA in early ICM with VT, or advanced ICM with VT. RCT data is almost exclusively on patients with modest ICM with VT, and this is not representative of the real-world scenario of patients with structural heart disease presenting with VT. Therefore the primary objective is to determine in all patients with structural heart disease and spontaneous or inducible VT, if catheter ablation compared to standard medical therapy with anti-arrhythmic drugs results in a reduction of a composite endpoint of recurrent VT, VT storm and death at a median follow up of 18 months.

Начало: 08.07.2020 Край: 30.06.2026 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT05524077

Активно (без набиране) Фаза 3

Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Biliary Atresia

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.

Начало: 08.07.2020 Край: 26.06.2026 Възраст: до 111 г. Лечение

Australia, Belgium, Canada +16 Albireo, an Ipsen Company NCT04336722

Активно (без набиране)

Amplatzer Amulet LAAO vs. NOAC

Atrial Fibrillation Stroke Bleeding

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Начало: 07.07.2020 Край: 01.04.2031 Възраст: от 18 г. Лечение

Australia, Canada, Czechia +12 Abbott Medical Devices NCT04226547

Активно (без набиране)

Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

Aneurysm, Intracranial

The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

Начало: 07.07.2020 Край: 13.09.2028 Възраст: 18–80 г. Лечение

Australia, Canada, United States Stryker Neurovascular NCT04195568

Активно (без набиране) Фаза 3

Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2)

Active Psoriatic Arthritis

This is a randomized, double-blinded, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tildrakizumab compared to placebo in anti-TNF naïve subjects with active PsA .

Начало: 01.07.2020 Край: 01.04.2026 Възраст: от 18 г. Лечение

Australia, Czechia, Germany +6 Sun Pharmaceutical Industries Limited NCT04314531

Активно (без набиране) Фаза 1/2

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Melanoma

Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advanced melanoma that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn: * About the safety and how well people tolerate pembrolizumab given with other treatments * How many people have melanoma that responds (gets smaller or goes away) to treatment

Начало: 01.07.2020 Край: 20.05.2026 Възраст: 18–120 г. Лечение

Argentina, Australia, Chile +11 Merck Sharp & Dohme LLC NCT04305054

Активно (без набиране) Фаза 3

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

Начало: 30.06.2020 Край: 20.02.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belarus +35 Actelion NCT04273945

Активно (без набиране) Фаза 3

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Crohn's Disease

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Начало: 22.06.2020 Край: 01.04.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +27 Eli Lilly and Company NCT04232553

Активно (без набиране) Фаза 3

A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

Alzheimer Disease

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease. Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab. Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.

Начало: 19.06.2020 Край: 01.11.2028 Възраст: 60–85 г. Лечение

Australia, Canada, Czechia +6 Eli Lilly and Company NCT04437511

Активно (без набиране) Фаза 3

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

Plasma Cell Myeloma

Primary Objectives: * Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) * Randomized Phase 3 Part: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in Part: * To assess overall response rate (ORR) * To assess duration of response (DOR) * To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) * To assess time to diagnostic (SLiM CRAB) progression or death * To assess time to first-line treatment for multiple myeloma (MM) * To assess the potential immunogenicity of isatuximab * Impact of abnormal chromosomal subtype on participant outcome Randomized Phase 3 Part: Key Secondary Objectives: To compare between the arms * MRD negativity * Sustained MRD negativity * Second progression-free survival (PFS2) * Overall survival Other Secondary Objectives: To evaluate in both arms * CR rate * ORR * DOR * Time to diagnostic (SLiM CRAB) progression * Time to biochemical progression * Time to first-line treatment for MM * Impact of abnormal chromosomal subtype on participant outcome * Safety and tolerability * Pharmacokinetics (PK) * Potential of isatuximab immunogenicity * Clinical outcome assessments (COAs)

Начало: 16.06.2020 Край: 21.10.2033 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +20 Sanofi NCT04270409

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