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Набира участници Фаза 3

A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction

Lung Transplant Rejection

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. Study details include: The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE. The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE. The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE. For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.

Начало: 10.10.2023 Край: 01.10.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +16 Sanofi NCT06082037

Набира участници

SEAL™ME: Saccular Endovascular Aneurysm Lattice System Multicenter Enrollment Global Registry

Aneurysm Aneurysm, Ruptured

Prospective, international, single-arm, multicenter, registry study. Patients presenting with evidence of Wide Neck unruptured or ruptured intracranial aneurysm (≤ 20 mm in widest diameter) requiring treatment will be enrolled into the study and treated using the SEAL™ System.

Начало: 09.10.2023 Край: 15.06.2030 Възраст: 18–80 г.

Colombia, New Zealand, Pakistan +1 Galaxy Therapeutics INC NCT05880680

Набира участници Фаза 3

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

Breast Cancer, Early Breast Cancer

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

Начало: 05.10.2023 Край: 06.05.2037 Възраст: 18–130 г. Лечение

Argentina, Australia, Belgium +39 AstraZeneca NCT05952557

Набира участници Фаза 4

Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

Multiple Myeloma

This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.

Начало: 03.10.2023 Край: 22.02.2032 Възраст: от 18 г. Лечение

Australia, Canada, China +3 Pfizer NCT06057402

Набира участници

Evaluation of the NaviFUS System in Drug Resistant Epilepsy

Epilepsy, Temporal Lobe Drug Resistant Epilepsy

Participants with drug-resistant epilepsy (DRE) enrolled in this study will receive focused ultrasound (FUS) treatment with the NaviFUS System, guided by the neuronavigation system to evaluate the safety and efficacy of using NaviFUS System. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi. The study consists of a 60-day screening period for baseline observation prior to treatment, a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System, and a safety follow-up period of 81 days.

Начало: 02.10.2023 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia Genovate-NaviFUS (Australia) Pty Ltd. NCT05947656

Набира участници Фаза 3

Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.

Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis (JIA) is the most common type of arthritis that affects children. The term "idiopathic" means "of unknown origin". It is a chronic (long-lasting) disease that causes swelling, warmth, and pain of one or more small joints. Systemic JIA ia a rare and serious form of JIA. Systemic" means it may affect not only the joints but other parts of the body, including the liver, lungs and heart. sJIA is more severe and can be more challenging to diagnose and treat than other types of juvenile idiopathic arthritis. It is a lifelong disease for many patients and can continue into adulthood. This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to \< 18 with systemic juvenile idiopathic arthritis (sJIA) and will include a tocilizumab treatment arm for reference. Adverse events and change in the disease activity will be assessed. Upadacitinib is an investigational drug being developed for the treatment of sJIA. Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive upadacitinib or tocilizumab reference. In cohort 2, participants will receive upadacitinib. Approximately 90 participants with sJIA will be enrolled in approximately 45 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily or tocilizumab subcutaneous injection or intravenous infusion as per local label for 52 weeks and followed for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits/calls during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Начало: 02.10.2023 Край: 01.06.2029 Възраст: 1–17 г. Лечение

Argentina, Australia, Brazil +13 AbbVie NCT05609630

Набира участници

Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity

Critical Illness Obesity

The DIRECT trial is a prospective, multi-centre, two arm parallel feasibility pilot randomised controlled trial. The primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. The trial will recruit 60 mechanically ventilated patients from 4-6 ICUs in Australia and New Zealand.

Начало: 02.10.2023 Край: 01.06.2026 Възраст: от 18 г. Друго

Australia, New Zealand Australian and New Zealand Intensive Care Research Cent NCT06053216

Набира участници Фаза 2

MR-Adaptive Radiation Therapy for Anal Cancer With EScalated-Treatment in a Risk-Optimized Approach

Anal Squamous Cell Carcinoma

The proposed study is a phase II, single arm, open-label trial of MR-guided radiation therapy (RT) with risk stratified RT dose selection in patients with anal cancer. Based on previous data, a risk adaptive treatment approached is proposed in 4 groups: Low risk, standard risk, intermediate risk, and high risk. Human papillomavirus (HPV) DNA will be analyzed to identify novel biomarkers that predict chemoradiotherapy (CRT) response and toxicity.

Начало: 29.09.2023 Край: 01.09.2028 Възраст: от 18 г. Лечение

Australia, Canada, United States University Health Network, Toronto NCT06050707

Набира участници

Post-Market Clinical Follow Up Study With Navitor Valve

Aortic Stenosis

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

Начало: 29.09.2023 Край: 01.12.2031 Възраст: 18–100 г.

Australia, France, Germany +6 Abbott Medical Devices NCT06008080

Набира участници Фаза 2

Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke

Acute Ischemic Stroke

STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS. Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.

Начало: 27.09.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia The Florey Institute of Neuroscience and Mental Health NCT05363397

Набира участници Фаза 1

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.

Начало: 25.09.2023 Край: 29.02.2028 Възраст: от 18 г. Лечение

Australia, Canada, Denmark +5 Incyte Corporation NCT05936359

Набира участници Фаза 1

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Prostate Cancer

A Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men with Newly Diagnosed Prostate Cancer (ASCERTAIN).

Начало: 21.09.2023 Край: 17.08.2026 Възраст: от 18 г. Фундаментална наука

Australia, Canada, Netherlands +4 AstraZeneca NCT05938270

Набира участници Фаза 1/2

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A

Hemophilia A

WP44714 is a Phase I/II, open-label, non-randomized, global, multicenter trial consisting of two parts: * Part 1 is a multiple-ascending dose (MAD) study in adult and adolescent male participants with severe or moderate hemophilia A with or without factor VIII (FVIII) inhibitors. * Part 2 is a multiple-dose study in pediatric male participants with severe or moderate hemophilia A with or without FVIII inhibitors. The overall aim of the study is to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of NXT007.

Начало: 21.09.2023 Край: 16.06.2030 Възраст: 2–59 г. Лечение

Canada, Italy, New Zealand +3 Hoffmann-La Roche NCT05987449

Набира участници

Red Blood Cell Transfusion in ECMO - A Feasibility Trial

Blood Loss Anemia Extracorporeal Membrane Oxygenation Complication Disability Physical Cognitive Ability, General +1

Extracorporeal Membrane Oxygenation (ECMO) is an invasive and resource intense treatment used to support critically ill patients who have suffered severe cardiac arrest, cardiac failure or respiratory failure (including severe cases of COVID-19). ECMO acts as a mechanical circulatory support temporarily replacing the function of the heart or lungs by oxygenating blood and removing carbon dioxide, allowing time for these organs to recover. Many critically ill patients, including those on ECMO, have an increased risk of bleeding and reduced production/increased destruction of red blood cells (RBCs). This can lead to anaemia (haemoglobin levels \

Начало: 20.09.2023 Край: 30.12.2025 Възраст: от 18 г. Здравни услуги

Australia Australian and New Zealand Intensive Care Research Cent NCT05814094

Набира участници Фаза 1

A Study of D3L-001 as Monotherapy in Subjects With HER2-Positive Advanced Solid Tumors

HER-2 Positive Advanced Solid Tumors

This first-in-human (FIH) study, multi-center, open-label, dose escalation and dose expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of D3L-001 in subjects with HER2-positive advanced solid tumors.

Начало: 19.09.2023 Край: 19.12.2028 Възраст: от 18 г. Лечение

Australia, China, United States D3 Bio (Wuxi) Co., Ltd NCT05957536

Набира участници

Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

Colorectal Polyp Colon Adenoma Colon Cancer

Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas

Начало: 19.09.2023 Край: 01.10.2028 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT05041478

Набира участници Фаза 2

MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder

PTSD Alcohol Use Disorder Alcohol Dependence Post-traumatic Stress Disorder +1

To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial.

Начало: 19.09.2023 Край: 01.05.2026 Възраст: от 18 г. Лечение

Australia University of Sydney NCT05709353

Набира участници Фаза 3

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

Relapsed Refractory Multiple Myeloma (RRMM)

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: * How long participants benefit from receiving linvoseltamab compared with EPd * How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much * What side effects happen from taking linvoseltamab compared to EPd * How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd * If there is any improvement in pain after treatment with linvoseltamab compared to EPd

Начало: 18.09.2023 Край: 19.04.2033 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +15 Regeneron Pharmaceuticals NCT05730036

Набира участници Фаза 1

Phase 1 Study of AWT020 in Advanced Cancer

Advanced Cancer

The aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.

Начало: 15.09.2023 Край: 30.09.2026 Възраст: от 18 г. Лечение

Australia Anwita Biosciences NCT06092580

Набира участници Фаза 1

IKS014 in Advanced Solid Tumors That Express HER2

Breast Cancer Gastric Cancer Gastroesophageal-junction Cancer

This study will evaluate the recommended dose for further clinical development, safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS014, a HER2 targeting antibody-drug conjugate, in patients with advanced solid tumors.

Начало: 14.09.2023 Край: 01.09.2027 Възраст: от 18 г. Лечение

Australia, New Zealand, Singapore +1 Iksuda Therapeutics Ltd. NCT05872295

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