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Набира участници Фаза 1

Trial of INI-4001 in Patients With Advanced Solid Tumours

Advanced Solid Tumor

Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors.

Начало: 01.07.2024 Край: 30.03.2027 Възраст: от 18 г. Лечение

Australia Inimmune Corporation NCT06302426

Набира участници

NODE (groiN ultrasOunD cancEr)

Vulvar Cancer Stage Ib Vulvar Cancer Stage II Lymph Node Metastasis Groin Node +1

This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months for 12 months.

Начало: 01.07.2024 Край: 31.12.2027 Възраст: от 18 г. Друго

Australia Queensland Centre for Gynaecological Cancer NCT06264167

Набира участници

Reducing Cognitive Impairment by Management of Heart Failure as a Modifiable Risk Factor

Heart Failure Cognitive Impairment Dementia Left Ventricular Dysfunction +2

This study will test the feasibility and effectiveness of an innovative model of care for cognitively impaired patients with heart failure. This program aims to improve cognition, reduce dementia risk and cardiovascular events, and will be supported by innovative digital technology for wide scale rollout and implementation. Findings from this research will transform the way healthcare is delivered to cognitively impaired patients with heart disease who have a very high risk of developing dementia.

Начало: 01.07.2024 Край: 01.07.2026 Възраст: от 18 г. Превенция

Australia Baker Heart and Diabetes Institute NCT06088212

Набира участници Фаза 1

A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC

Hepatocellular Carcinoma

This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 alone (Module 1) and in combination with Atezo/Bev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.

Начало: 01.07.2024 Край: 31.05.2028 Възраст: от 18 г. Лечение

Australia, South Korea, Taiwan Myeloid Therapeutics NCT06478693

Набира участници

National Robotics-Assisted Radical Prostatectomy Database

Database Prostate Cancer Robotic-assisted Radical Prostatectomy Surgical Outcomes +3

In Australia, nearly 70 men are diagnosed with Prostate cancer every day. Prostate removal (Radical Prostatectomy) is the proven treatment option to control cancer spread. Most of the prostate removal surgeries are done using robots. Robotic assisted prostate removal surgeries have been invented to minimise the risk of side effects post-surgery. Doctors prefer the robots over open surgery as there are benefits to patients (shorter hospital stays, lesser blood loss and better quality of life) and surgeons (better dexterity, improved field of vision and less pain). However, the cost of the robot outweighs the benefits at present and there is very less information concerning the long-term outcomes for patients. Studies conducted so far are small scale studies and the results from these studies cannot be generalized to the population at large in Australia. So, there is need for a largescale study that will look at the long-term outcomes and the factors that impact robotic surgeries across the metropolitan and rural hospital sectors. Hence, this comprehensive database has been setup to collaborate with major hospitals, across metropolitan and rural areas in Australia. Through this database, researchers will be able to explore the diagnostic pathway for Prostate cancer and understand the long-term benefits of robotic surgery through patient reported questionnaires. Outcomes from this database will also help compare the quality of care against other powerhouses of robotic surgery. Eventually, the database aims to standardize diagnostic pathways and clinical notes that are the same across different hospitals conducting robotic-assisted surgeries for Prostatectomy and improve care for prostate cancer patients across the country.

Начало: 01.07.2024 Край: 01.12.2050 Възраст: 18–90 г.

Australia Melbourne Health NCT06279260

Набира участници Фаза 2

A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis

Onychomycosis

The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis

Начало: 01.07.2024 Край: 30.01.2026 Възраст: 18–70 г. Лечение

New Zealand AmtixBio Co., Ltd. NCT06327295

Набира участници Фаза 3

A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

Cutaneous Lupus Erythematosus

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with chronic and/or subacute cutaneous lupus erythematosus (CLE).

Начало: 29.06.2024 Край: 20.08.2027 Възраст: 18–70 г. Лечение

Argentina, Australia, Belgium +27 AstraZeneca NCT06015737

Набира участници

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Atrial Fibrillation

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Начало: 28.06.2024 Край: 30.06.2026 Възраст: 18–80 г. Лечение

Australia, United States Biosense Webster, Inc. NCT06455098

Набира участници

Cognitive Behavioural Therapy for Avoidant/Restrictive Food Intake Disorder (CBT-AR)

Avoidant/Restrictive Food Intake Disorder (ARFID)

CBT-AR describes an adaption of cognitive behavioural therapy for use with individuals diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID). The purpose of this evaluation is to determine the feasibility, acceptability and effectiveness of this treatment. It is hypothesised that this treatment will be feasible and acceptable to clinicians, carers and patients and will be effective in reducing symptoms of ARFID for patients.

Начало: 27.06.2024 Край: 27.06.2027 Възраст: 12–25 г. Лечение

Australia Orygen NCT06463470

Набира участници Фаза 3

A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.

Начало: 27.06.2024 Край: 01.12.2026 Възраст: от 12 г. Лечение

Argentina, Australia, Belgium +36 AbbVie NCT06468228

Набира участници Фаза 2

A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)

Stage II Nasopharyngeal Carcinoma AJCC v8 Stage III Nasopharyngeal Carcinoma AJCC v8 Stage IV Nasopharyngeal Carcinoma AJCC v8

This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). 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. Chemotherapy drugs, such as gemcitabine and cisplatin, 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. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.

Начало: 25.06.2024 Край: 31.12.2026 Възраст: до 21 г. Лечение

Canada, New Zealand, Puerto Rico +1 National Cancer Institute (NCI) NCT06064097

Набира участници Фаза 3

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

Head and Neck Squamous Cell Carcinoma

This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.

Начало: 25.06.2024 Край: 01.03.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Merus B.V. NCT06496178

Набира участници Фаза 3

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

Cardiovascular Risk Acute Myocardial Infarction (AMI)

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. The participant will need to inject the study medicine into a flat skin surface in there stomach, thigh, or upper arm once every month. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

Начало: 25.06.2024 Край: 14.12.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +20 Novo Nordisk A/S NCT06118281

Набира участници

The RECLAIM Study.

Chronic Migraine High Frequency Episodic Migraine

The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.

Начало: 24.06.2024 Край: 31.01.2029 Възраст: 18–84 г. Лечение

Australia, Belgium, Netherlands Salvia BioElectronics NCT06450444

Набира участници Фаза 1

A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias

Cardiovascular Metabolic Disease Dyslipidemias Lipid Disorder +6

This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.

Начало: 21.06.2024 Край: 01.06.2028 Възраст: 18–75 г. Лечение

Australia, New Zealand, United Kingdom +1 CRISPR Therapeutics AG NCT07491172

Набира участници Фаза 2

Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma

The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival.

Начало: 21.06.2024 Край: 01.07.2036 Възраст: от 18 г. Лечение

Australia Melanoma Institute Australia NCT06288191

Набира участници Фаза 1/2

A Phase I/II Clinical Trial with SENS-501 in Children Suffering from Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

OTOF Gene Mutation DFNB9 Congenital Deafness Hearing Disorders +4

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

Начало: 21.06.2024 Край: 01.07.2031 Възраст: 6–31 г. Лечение

Australia, France Sensorion NCT06370351

Набира участници Фаза 1/2

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

Colorectal Cancer Pancreatic Ductal Adenocarcinoma Biliary Tract Cancer

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn: * About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment

Начало: 20.06.2024 Край: 16.10.2029 Възраст: от 18 г. Лечение

Australia, Canada, Chile +10 Merck Sharp & Dohme LLC NCT06428409

Набира участници

Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia

Travelers Diarrhea

The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population.

Начало: 20.06.2024 Край: 01.07.2026 Възраст: 18–100 г.

Australia Lumen Bioscience, Inc. NCT06363890

Набира участници Фаза 1/2

A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)

Alpha 1-Antitrypsin Deficiency

This is a Phase 1/2, multicenter, open-label, dose-exploration (Phase 1) and dose-expansion (Phase 2) study to evaluate the safety, tolerability, PK/PD, and efficacy of BEAM-302 in adult patients with AATD-associated lung disease and/or liver disease and to determine the optimal biological dose (OBD).

Начало: 19.06.2024 Край: 01.05.2030 Възраст: 18–70 г. Лечение

Australia, Ireland, Netherlands +3 Beam Therapeutics Inc. NCT06389877

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