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The ENCIRCLE Trial

Mitral Regurgitation Mitral Valve Insufficiency

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Начало: 12.11.2020 Край: 28.02.2031 Възраст: от 18 г. Лечение

Australia, Canada, Israel +3 Edwards Lifesciences NCT04153292

Набира участници Фаза 3

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

Trauma Traumatic Injury Traumatic Brain Injury Wounds and Injuries +4

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

Начало: 09.11.2020 Край: 31.08.2027 Възраст: 18–75 г. Лечение

Australia, Belgium, Finland +6 Australian and New Zealand Intensive Care Research Cent NCT04588311

Набира участници

LANDMARK Trial: a Randomised Controlled Trial of Myval THV

Aortic Valve Stenosis

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

Начало: 04.11.2020 Край: 31.12.2033 Възраст: от 18 г. Лечение

Belarus, Brazil, Croatia +12 Meril Life Sciences Pvt. Ltd. NCT04275726

Набира участници Фаза 1/2

Study to Evaluate the Safety and Tolerability of EP0042

Acute Myeloid Leukemia Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes

A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).

Начало: 02.11.2020 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Netherlands, United Kingdom Ellipses Pharma NCT04581512

Набира участници

CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Mitral Regurgitation

This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.

Начало: 01.11.2020 Край: 31.12.2030 Възраст: от 18 г.

Australia, Canada, Denmark +6 Universitätsklinikum Hamburg-Eppendorf NCT04688190

Набира участници Фаза 1/2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Advanced Solid Tumor Advanced Malignant Neoplasm Metastatic Cancer Metastatic Solid Tumor +26

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

Начало: 29.10.2020 Край: 31.12.2027 Възраст: от 12 г. Лечение

Australia, France, Germany +6 PMV Pharmaceuticals, Inc NCT04585750

Набира участници Фаза 1

A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

Solid Tumor Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer

This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.

Начало: 26.10.2020 Край: 30.06.2028 Възраст: от 18 г. Лечение

Australia, Bosnia and Herzegovina, Bulgaria +4 K-Group, Beta, Inc., a wholly owned subsidiary of Zenta NCT04516447

Набира участници

Abbott Vascular Medical Device Registry

Acute Myocardial Infarction Restenoses, Coronary Coronary Artery Lesions Venous Embolism +1

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

Начало: 25.10.2020 Край: 01.11.2031 Възраст: от 18 г.

Australia, Belgium, China +10 Abbott Medical Devices NCT04573660

Набира участници Фаза 2

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Myelofibrosis Indolent Systemic Mastocytosis

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

Начало: 22.10.2020 Край: 31.12.2025 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +10 Telios Pharma, Inc. NCT04655118

Набира участници

NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Aortic Dissection Aortic Aneurysm Intramural Hematoma Penetrating Aortic Ulcer

Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.

Начало: 20.10.2020 Край: 01.10.2029 Възраст: от 18 г. Лечение

New Zealand, United States Endospan Ltd. NCT04471909

Набира участници Фаза 2

A Study of Combination Chemotherapy for Patients With Newly Diagnosed DAWT and Relapsed FHWT

Anaplastic Kidney Wilms Tumor Recurrent Kidney Wilms Tumor Stage II Kidney Wilms Tumor Stage III Kidney Wilms Tumor +1

This phase II trial studies how well combination chemotherapy works in treating patients with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed). Drugs used in chemotherapy regimens such as UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) and ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out what effects, good and/or bad, regimen UH-3 has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT) and regimen ICE/Cyclo/Topo has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).

Начало: 19.10.2020 Край: 01.07.2027 Възраст: до 30 г. Лечение

Australia, Canada, New Zealand +3 Children's Oncology Group NCT04322318

Набира участници Фаза 1

Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults

Glioblastoma Malignant Glioma Recurrent Glioblastoma Recurrent Malignant Glioma +2

This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Начало: 02.10.2020 Край: 01.03.2029 Възраст: 6–25 г. Лечение

Australia, United States Sabine Mueller, MD, PhD NCT04323046

Набира участници

Effect of the MobiusHD® in Patients With Heart Failure

Heart Failure With Reduced Ejection Fraction

This is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and effectiveness of the MobiusHD® in patients with heart failure and reduced ejection fraction.

Начало: 02.10.2020 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Canada, Georgia +2 Vascular Dynamics, Inc. NCT04590001

Набира участници

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant: A Prospective, Multi-Center Global Registry

Rotator Cuff Injuries

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.

Начало: 01.10.2020 Край: 31.12.2027 Възраст: от 18 г.

Australia, France, Germany +2 Smith & Nephew, Inc. NCT06857084

Набира участници

The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

Peripheral Arterial Disease Vascular Diseases Stenosis Femoropopliteal Stenosis

To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

Начало: 22.09.2020 Край: 01.03.2030 Лечение

Australia, New Zealand Efemoral Medical, Inc. NCT04584632

Набира участници Фаза 1/2

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

Rhabdomyosarcoma

FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

Начало: 17.09.2020 Край: 01.06.2030 Лечение

Australia, Belgium, Czechia +14 University of Birmingham NCT04625907

Набира участници Фаза 1/2

A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors

Solid Tumor Melanoma HNSCC Sarcoma +2

This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.

Начало: 17.09.2020 Край: 10.01.2027 Възраст: от 18 г. Лечение

Australia, United States ImmVira Pharma Co. Ltd NCT04370587

Набира участници Фаза 1

A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors

Solid Tumor

This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6 ribonucleic acid lipoplexes (RNA-LPX) in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Начало: 16.09.2020 Край: 01.08.2041 Възраст: от 18 г. Лечение

Australia, Germany, Netherlands +1 BioNTech Cell & Gene Therapies GmbH NCT04503278

Набира участници Фаза 2

A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS)

Myelodysplastic Syndromes Cytopenia

The main aim of this study is to learn how safe elritercept is and how well adults with anemia associated with lower-risk MDS tolerate treatment with different doses of elritercept. Other aims are to learn how safe elritercept is by looking at how many participants have MDS that worsens during the study and learn about the effects of elritercept on anemia linked to MDS. The study will also look to learn how elritercept affects the production of healthy RBCs.

Начало: 19.08.2020 Край: 30.10.2031 Възраст: от 18 г. Лечение

Australia, Czechia, France +5 Takeda NCT04419649

Набира участници Фаза 3

A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

DLBCL Diffuse Large B Cell Lymphoma

This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.

Начало: 19.08.2020 Край: 28.12.2028 Възраст: от 75 г. Лечение

Australia, Denmark, Finland +4 Nordic Lymphoma Group NCT04332822

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