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Real World Assessment of People Living With Chronic Hepatitis B in Australia

Hepatitis B

The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.

Начало: 17.02.2022 Край: 01.07.2027 Възраст: от 18 г.

Australia Kirby Institute NCT04914611

Набира участници Фаза 4

Staphylococcus Aureus Network Adaptive Platform Trial

Staphylococcus Aureus Bacteremia

The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).

Начало: 16.02.2022 Край: 01.12.2028 Лечение

Australia, Canada, Israel +7 University of Melbourne NCT05137119

Набира участници

Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

Arthroplasty Replacement Knee

Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.

Начало: 12.02.2022 Край: 31.03.2028 Възраст: от 18 г. Лечение

Australia, China, Hong Kong +1 Smith & Nephew, Inc. NCT04848896

Набира участници Фаза 1/2

Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors

Solid Tumor Advanced Solid Tumor

This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of IMP9064 as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors

Начало: 11.02.2022 Край: 31.12.2026 Възраст: от 18 г. Лечение

Australia, China, Taiwan +1 Impact Therapeutics, Inc. NCT05269316

Набира участници Фаза 3

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Crohn's Disease (CD)

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

Начало: 10.02.2022 Край: 22.05.2026 Възраст: 2–17 г. Лечение

Australia, Belgium, Canada +15 Takeda NCT04779320

Набира участници Фаза 2

NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma

Renal Cell Carcinoma, Clear Cell, Somatic

This is a prospective, open label, phase II, randomised, non-comparative clinical trial, evaluating changes in tumour-responsive T-cells following neoadjuvant stereotactic ablative body radiotherapy (SABR) with or without pembrolizumab, prior to nephrectomy, in patients with localised primary clear cell renal cell carcinoma (ccRCC).

Начало: 08.02.2022 Край: 01.12.2025 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT05024318

Набира участници Фаза 2

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

Primary Immune Thrombocytopenia

This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP). This study will focus on participants with persistent (\>3 months and ≤12 months), or chronic (\>12 months) ITP

Начало: 02.02.2022 Край: 02.08.2028 Възраст: 18–70 г. Лечение

Australia, Canada, Czechia +4 Pfizer NCT05070845

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Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)

Pancreatic Necrosis

Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current evidence supports a minimally invasive drainage approach to infected WON. The current suggested approach in international guidelines is the endoscopic step-up approach. However, recent evidence from large national cohorts support the use of direct endoscopic necrosectomy (DEN) at the time of stent placement, resulting in earlier resolution of WON and less number of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.

Начало: 01.02.2022 Край: 30.06.2026 Възраст: от 18 г. Лечение

Australia, Hong Kong, India +3 Chinese University of Hong Kong NCT05252897

Набира участници Фаза 1/2

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

HER2-positive Advanced Solid Tumor

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.

Начало: 31.01.2022 Край: 01.10.2027 Възраст: от 18 г. Лечение

Australia, China, Puerto Rico +3 DualityBio Inc. NCT05150691

Набира участници Фаза 1/2

CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

Diffuse Midline Glioma, H3 K27-Altered Metastatic Malignant Neoplasm in the Central Nervous System Recurrent Diffuse Intrinsic Pontine Glioma Recurrent Diffuse Midline Glioma, H3 K27-Altered +6

This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.

Начало: 28.01.2022 Край: 31.12.2026 Възраст: 12–21 г. Лечение

Australia, United States Children's Oncology Group NCT04870944

Набира участници Фаза 3

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Type 2 Diabetes Mellitus Chronic Kidney Diseases

The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.

Начало: 05.01.2022 Край: 01.12.2029 Възраст: 30–80 г. Лечение

Australia, Canada, Mexico +4 Prokidney NCT05099770

Набира участници Фаза 1/2

A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Locally Advanced Solid Tumor Metastatic Solid Tumor

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.

Начало: 04.01.2022 Край: 31.12.2028 Възраст: от 12 г. Лечение

Australia, Belgium, Canada +11 Nuvalent Inc. NCT05118789

Набира участници Фаза 1

PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study

NSCLC

Outcome for patients diagnosed with advanced lung cancer remains poor; alternative treatment options are urgently needed. Studies in other metastatic cancers indicate radiotherapy to the primary tumour can improve outcomes. The investigators postulate this will also be observed in lung cancer patients. The aim of this pilot study is to assess the safety and feasibility of stereotactic ablative radiotherapy (SABR) to the lung primary prior to standard of care (SoC) systemic therapy in advanced non-small cell lung cancer (NSCLC). Forty patients with advanced (Stage IV) NSCLC will be recruited across the five Peter Mac campuses. Patients will be randomised to receive SoC systemic therapy with or without radiotherapy to the lung primary. Radiotherapy will be delivered before cycle 3 of SoC systemic therapy. Biospecimens will be collected for future translational research. The primary outcome of the study (feasibility of the protocol) will be assessed by the ability to deliver radiotherapy to the lung cancer primary, whilst meeting dose constraints. The study will also 1) evaluate proportion of patients who are willing to be randomised; 2) describe toxicity during the follow up period in each arm; 3) describe progression free survival.

Начало: 03.01.2022 Край: 01.04.2025 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT05222087

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RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

Rib; Fracture

This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.

Начало: 02.01.2022 Край: 30.12.2026 Възраст: от 18 г.

Australia, South Korea Zimmer Biomet NCT05146986

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HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation

Hepatocellular Carcinoma HCC

All international guidelines recommend 6-monthly ultrasound surveillance for patients at risk for liver cancer (hepatocellular carcinoma or HCC), such as patients with cirrhosis. The aim of surveillance is to detect HCC at an early stage when it is still potentially curable. Currently only 4 out of 10 HCCs are detected at the early stage. Ultrasound surveillance for HCC has a wide ranging sensitivity, dependent on many factors such as operator experience, patient body habitus and liver parenchymal heterogeneity due to chronic liver disease and cirrhosis. In a select group of patients, surveillance ultrasound can be suboptimal or near non-diagnostic. Currently no guideline offers an alternative surveillance tool for patients who have suboptimal surveillance ultrasounds.

Начало: 01.01.2022 Край: 01.03.2027 Възраст: 20–85 г. Скрининг

Australia, New Zealand Concord Repatriation General Hospital NCT04455932

Набира участници Фаза 1/2

HALOS: A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Multiple Ascending Doses of ION582 in Participants With Angelman Syndrome

Angelman Syndrome

The purpose of this study is to evaluate the safety and tolerability of ascending doses of ION582 administered intrathecally in participants with Angelman syndrome.

Начало: 22.12.2021 Край: 01.03.2029 Възраст: до 50 г. Лечение

Australia, France, Israel +3 Ionis Pharmaceuticals, Inc. NCT05127226

Набира участници Фаза 1

A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

Advanced Solid Tumors

This is a study evaluating the safety, pharmacokinetics, and efficacy of calderasib alone, and calderasib plus other combination therapies in participants with advanced solid tumors with identified kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation.

Начало: 17.12.2021 Край: 25.02.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +18 Merck Sharp & Dohme LLC NCT05067283

Набира участници Фаза 2

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

Myelofibrosis

The main aim of this study is to learn how safe elritercept is and how well it is tolerated when taken alone and in combination with the JAK inhibitor, ruxolitinib. Other aims are to learn about the effects of elritercept on the signs and symptoms of MF when taken with or without ruxolitinib and to learn how elritercept affects the body, how the body processes elritercept, and the effects of elritercept on anemia when taken with or without ruxolitinib The study will also check on how safe elritercept is and how well it is tolerated.

Начало: 16.12.2021 Край: 28.02.2030 Възраст: от 18 г. Лечение

Australia, Brazil, France +4 Takeda NCT05037760

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Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease

Motor Neuron Disease / Amyotrophic Lateral Sclerosis

A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.

Начало: 15.12.2021 Край: 28.02.2028 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT05136222

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RFC1 Natural History Study

Ataxia

This international, multi-center, multi-modal and prospective observational study aims to determine the phenotypic spectrum and the natural progression of the RFC1 repeat expansion disease, and to seek and validate digital, imaging, and molecular biomarkers that aid in diagnosis and serve as outcome measures in future clinical trials of this novel, but frequent ataxia with late adult-onset.

Начало: 14.12.2021 Край: 01.12.2026 Възраст: от 18 г.

Australia, Brazil, France +4 Prof. Dr. Matthis Synofzik NCT05177809

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