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Набира участници Фаза 1

AMT-253 in Patients With Selected Advanced Solid Tumours

Advanced Solid Tumor

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-253, in Patients with Advanced Solid Tumors

Начало: 06.11.2023 Край: 30.12.2026 Възраст: от 18 г. Лечение

Australia Multitude Therapeutics (Australia) Pty Ltd NCT05906862

Набира участници

Trifecta-Lung cfDNA-MMDx Study

Lung Transplantation

Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.

Начало: 01.11.2023 Край: 01.12.2027 Възраст: от 18 г.

Australia, Canada, Czechia +1 University of Alberta NCT05837663

Набира участници

A Study to Investigate the Feasibility and Respiratory Effects of Stimulating Two Functional Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea

Sleep Apnea Sleep Apnea, Obstructive Sleep Apnea Syndromes Sleep Disorder

This proof-of-concept study is to collect acute and short-term sub-acute (if applicable) changes in respiratory parameters following the percutaneous placement of electrode arrays. Acute placement and data collection will be conducted while performing a Drug Induced Sleep Endoscopy (DISE) where the goal will be to quantify changes in airflow with stimulation. Data will also be collected during a one- or two-night polysomnography (PSG) to investigate airflow and sleep stability responses with and without different levels of stimulation during sleep. Where feasible, OSA severity data will be collected, as measured via the apnea/hypopnea index (AHI) with stimulation versus without stimulation as a secondary objective. Both data collections will be done when stimulating the hypoglossal nerve (HGN) or Genioglossus muscle (GG) and a second functional target (Ansa Cervicalis - AC) or the strap muscles (sternohyoid and sternothyroid) with a set of electrode arrays either in combination or separately.

Начало: 01.11.2023 Край: 01.11.2024 Възраст: от 18 г. Фундаментална наука

Australia Invicta Medical Inc. NCT06627127

Набира участници Фаза 1

Study of ISB 2001 in Relapsed/Refractory Multiple Myeloma (TRIgnite-1)

Relapsed/Refractory Multiple Myeloma

This study is a first-in-human, Phase 1, open-label study that will evaluate safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma (R/R MM).

Начало: 01.11.2023 Край: 01.07.2027 Възраст: от 18 г. Лечение

Australia, France, India +4 Ichnos Sciences SA NCT05862012

Набира участници Фаза 4

Positioning of Esketamine Treatment in the Real-world Management of Depression

Major Depressive Disorder

The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: * to investigate whether Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: * attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses

Начало: 31.10.2023 Край: 15.01.2026 Възраст: 18–65 г. Лечение

Australia Royal North Shore Hospital NCT06103760

Набира участници Фаза 1/2

PK and PD Study of NPI-001 and Cysteamine Bitartrate

Cystinosis

Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.

Начало: 29.10.2023 Край: 01.08.2026 Възраст: от 10 г. Лечение

Australia Nacuity Pharmaceuticals, Inc. NCT05994534

Набира участници

Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Multiple Sclerosis

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries). The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Начало: 27.10.2023 Край: 06.07.2032

Australia, Germany, Ireland +3 Biogen NCT05658497

Набира участници Фаза 2/3

Nectero EAST System Clinical Study

Abdominal Aortic Aneurysm

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

Начало: 25.10.2023 Край: 31.12.2029 Възраст: 21–85 г. Лечение

Australia, New Zealand, United States Nectero Medical, Inc. NCT06001918

Набира участници Фаза 3

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

Myelodysplastic Syndromes

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).

Начало: 24.10.2023 Край: 11.03.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +18 Bristol-Myers Squibb NCT05949684

Набира участници

VOLT CE Mark Study

Atrial Arrhythmia Atrial Fibrillation Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.

Начало: 24.10.2023 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Czechia +6 Abbott Medical Devices NCT06106594

Набира участници Фаза 1/2

A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer

Colorectal Cancer Metastatic

This study aims to determine the safety and best response of treatment with CNA3103 (Leucine-rich repeat-containing G protein-coupled receptor 5 \[LGR5\]-targeted, Autologous Chimeric Antigen Receptor (CAR) -T Cells), for participants with Metastatic Colorectal Cancer. Participants may undergo a pre-screening biopsy procedure to determine expression of LGR5. Participants will undergo screening procedures, including leukapheresis (collection of T cells) and lymphodepletion (chemotherapy), up to 47 days prior to CNA3103 dosing. Participants will receive a single Intravenous dose of CNA3103. Expansion cohorts will open after determination of the maximum tolerated dose and recommended phase 2 dose in the dose escalation stage. Participants will be followed up, monitored and will attend study visits for safety and research related tests and procedures for 2 years until disease progression, unacceptable toxicity or intolerable adverse event/s, death or withdrawal of consent.

Начало: 24.10.2023 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia Carina Biotech Limited NCT05759728

Набира участници Фаза 3

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

Lymphoma

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Начало: 22.10.2023 Край: 31.03.2028 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +10 Hoffmann-La Roche NCT06084936

Набира участници Фаза 1

A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects

Healthy Volunteers

This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects. Approximately 86 subjects will be enrolled in the study.

Начало: 20.10.2023 Край: 01.12.2024 Възраст: 18–45 г. Друго

Australia Zhejiang Vimgreen Pharmaceuticals, Ltd. NCT06081465

Набира участници

Risk-guided Disease managEment Plan to prevEnt CAD in Patients Treated With Previous Cancer

Coronary Artery Disease

REDEEM-CAD is a prospective multi-centre study of CAD risk evaluation and management in cancer survivors 40-70 years with chemotherapy or radiotherapy \>5 years ago.

Начало: 18.10.2023 Край: 01.05.2026 Възраст: 40–70 г.

Australia Baker Heart and Diabetes Institute NCT05366153

Набира участници Фаза 1

A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants

Healthy

This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) of orally or intravenously administered LTG-001 in healthy male and female participants

Начало: 17.10.2023 Край: 28.04.2026 Възраст: 18–55 г. Лечение

New Zealand Latigo Biotherapeutics NCT06049095

Набира участници

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Aortoiliac Occlusive Disease Peripheral Arterial Disease

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Начало: 17.10.2023 Край: 31.01.2032 Възраст: от 18 г. Лечение

Germany, Netherlands, New Zealand +1 W.L.Gore & Associates NCT05811364

Набира участници Фаза 1

A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.

Triple Negative Breast Cancer Diffuse Large B Cell Lymphoma Follicular Lymphoma Lymphoma, Non-Hodgkin +10

A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and/or recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.

Начало: 13.10.2023 Край: 29.08.2026 Възраст: от 18 г. Лечение

Australia, United States OncoNano Medicine, Inc. NCT06022029

Набира участници Фаза 1

A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors

Advanced / Metastatic Solid Tumor

This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.

Начало: 12.10.2023 Край: 01.12.2025 Възраст: от 18 г. Лечение

Australia Stingray Therapeutics NCT06063681

Набира участници Фаза 2

A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.

Mantle Cell Lymphoma Mantle Cell Lymphoma Refractory

The goal of this clinical trial is to evaluate the safety and response of combining Pirtobrutinib and Glofitimab in patients with relapsed MCL. The main question it aims to answer are: * Will additive and synergistic effects be observed when using a combination of glofitamab and pirtobrutinib? * Will this combination be safe and lead to high complete- and remission rates with no residual disease? Pirtobrutinib will be given to all participants as an oral tablet for the duration of the entire study. Participants will receive other treatment in 3 phases: 1. Treatment Ramp-Up 1. Treatment with Obinutuzumab by Intravenous (IV) 2. An initial dose level of Glofitamab will evaluate step-up dosing. If excessive adverse events are observed, a lower initial dose will be used. 2. Fixed course combination phase: Treatment with Glofitamab by IV 3. Maintenance phase: Glofitamab is discontinued. 200mg oral daily

Начало: 12.10.2023 Край: 01.04.2037 Възраст: от 18 г. Лечение

Australia Australasian Leukaemia and Lymphoma Group NCT05833763

Набира участници Фаза 3

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Alopecia Areata

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose. 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.

Начало: 11.10.2023 Край: 01.04.2030 Възраст: 12–63 г. Лечение

Argentina, Australia, Belgium +24 AbbVie NCT06012240

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