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Намерени 3,079 изпитвания Стр. 103 от 154

Активно (без набиране) Фаза 3

Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP

Hypophosphatasia

The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.

Начало: 14.05.2024 Край: 24.08.2028 Възраст: 2–11 г. Лечение

Australia, Belgium, Brazil +13 Alexion Pharmaceuticals, Inc. NCT06079359

Активно (без набиране) Фаза 2/3

INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC

Head and Neck Squamous Cell Carcinoma (HNSCC)

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody INBRX-106 combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with locally advanced recurrent or metastatic head and neck squamous cell carcinoma (R/M HSNSCC) incurable by local therapies, expressing PD-L1 with a combined proportion score (CPS) ≥20.

Начало: 14.05.2024 Край: 01.05.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Bulgaria +10 Inhibrx Biosciences, Inc NCT06295731

Активно (без набиране) Фаза 3

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Advanced or Metastatic NRAS-mutant Melanoma

Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2. Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).

Начало: 29.04.2024 Край: 01.12.2028 Възраст: 18–99 г. Лечение

Australia, Canada, Czechia +6 Erasca, Inc. NCT06346067

Активно (без набиране) Фаза 1

SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS

AML/MDS CD33 Expressing Hematological Malignancies FLT3 Expressing Hematological Malignancies

This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.

Начало: 22.04.2024 Край: 01.08.2040 Възраст: 18–74 г. Лечение

Australia, United States Senti Biosciences NCT06325748

Активно (без набиране) Фаза 1

RT-310 Dose Escalation BPH Study

BPH (Benign Prostatic Hyperplasia) Lower Urinary Tract Symptoms

RT-310, a novel implant, is intended to minimally invasive treat locally the prostate gland for the management of prostate disease, while minimizing side-effects. The objectives of the study are to assess whether RT-310 is safe and feasible for the participant population.

Начало: 19.04.2024 Край: 01.12.2027 Възраст: 50–80 г. Лечение

Australia, New Zealand Resurge Therapeutics Inc. NCT06136819

Активно (без набиране) Фаза 3

A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Cardiomyopathy, Hypertrophic

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of mavacamten in adolescent patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Начало: 17.04.2024 Край: 28.03.2031 Възраст: 12–17 г. Лечение

Australia, Canada, France +6 Bristol-Myers Squibb NCT06253221

Активно (без набиране) Фаза 4

Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma

Asthma

The goal of this study is to assess and compare the effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol trifenatate (FF/UMEC/VI) with inhaled corticosteroids/long-acting beta-2 agonists (ICS/LABA) in adult participants with uncontrolled asthma

Начало: 16.04.2024 Край: 31.03.2027 Възраст: 18–75 г. Лечение

Argentina, Australia, Canada +5 GlaxoSmithKline NCT06372496

Активно (без набиране) Фаза 3

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Relapsing Multiple Sclerosis Secondary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 \[EFC16033\], GEMINI 2 \[EFC16034\], HERCULES \[EFC16645\], or PERSEUS \[EFC16035\]). SUBSTUDY: ToleDYNAMIC substudy

Начало: 16.04.2024 Край: 30.04.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +40 Sanofi NCT06372145

Активно (без набиране)

Duration of Protection of Nirsevimab Against Hospitalisation for Respiratory Syncytial Virus Infection

Respiratory Syncytial Viral (RSV) Infections

Respiratory syncytial virus (RSV) is a leading cause of hospitalizations for acute lower respiratory tract infection (LRTI) in infants. In Australia approximately 1.5% of infants are hospitalized due to RSV, 80% of whom are born full-term and are otherwise healthy. Two randomized trials have used a seasonal implementation strategy to show nirsevimab, a long-acting monoclonal antibody, has sustained efficacy against RSV LRTI hospitalizations in the first 150-180 days after administration. Nirsevimab has been approved in many countries for the prevention of RSV-LRTI in neonates and infants. However, the protection offered by nirsevimab beyond 180 days remains unknown. Queensland is a large Australian state spanning the tropical and sub-tropical climate zones, where RSV circulates year-round. The Queensland government publicly funded nirsevimab for all infants at birth from 15 April 2024. The aim of this study is to estimate the duration of effectiveness of nirsevimab against RSV-related hospitalizations. A case-control study will be conducted using routinely collected linked data. Cases will be children born in Queensland from 15 April 2024 to 14 April 2025 who are hospitalised with an RSV-related condition prior to 14 April 2026. Controls will be drawn from the set of infants who are admitted to the same hospital in a 5:1 ratio, and matched on age and sex using the Queensland Perinatal Data Collection. Nirsevimab receipt will be extracted from hospital's electronic medical records and linked to hospitalization data by the Queensland Health Data Linkage Unit. Duration of protection against RSV-related hospitalisation due to nirsevimab will be assessed using multivariable logistic regression model accounting for matching and adjusting for confounding variables. This case-control study will determine the level and duration of protection offered by nirsevimab in a region with year-round RSV circulation and inform future prevention strategies. Interim analysis is expected to be available at the time of the conference, allowing for early dissemination of this first evidence about nirsevimab duration of protection beyond 180 days. Funding: From Sanofi and AstraZeneca through a collaboration grant.

Начало: 15.04.2024 Край: 31.03.2027 Възраст: до 1 г.

Australia Griffith University NCT06993753

Активно (без набиране) Фаза 2

A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004).

Renal Cell Carcinoma

The primary objective of the study is to compare intismeran autogene plus pembrolizumab to placebo plus pembrolizumab in participants with renal cell carcinoma (RCC) with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

Начало: 10.04.2024 Край: 08.06.2032 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Merck Sharp & Dohme LLC NCT06307431

Активно (без набиране)

The Egg Up Trial - Testing a New Treatment Pathway for Infants With Newly Diagnosed Egg Allergy

Food Allergy Food Allergy in Infants

The goal of this study is to test the safety and feasibility of a change in management approach for infants with newly diagnosed egg allergy. Infants with newly diagnosed egg allergy will have egg introduced via a gradual and graded home based approach known as an "egg ladder" supervised by a dietitian. The main questions this study aims to answer are how safe and feasible are home-based dietitian-led "egg ladders" as a treatment pathway to achieve tolerance of egg for newly diagnosed infants with egg allergy.

Начало: 09.04.2024 Край: 01.03.2026 Възраст: 4–12 г. Лечение

Australia Murdoch Childrens Research Institute NCT06273605

Активно (без набиране) Фаза 3

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

Sjögren's Syndrome (SS)

Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

Начало: 08.04.2024 Край: 17.12.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +22 Amgen NCT06245408

Активно (без набиране) Фаза 1

Study of ARO-CFB in Adult Healthy Volunteers

IgA Nephropathy

The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.

Начало: 05.04.2024 Край: 01.03.2026 Възраст: 18–70 г. Лечение

New Zealand Arrowhead Pharmaceuticals NCT06209177

Активно (без набиране)

Small Steps Towards Improving Activity and Sleep Habits to Decrease the Risk of Dementia

Dementia Alzheimer Disease

This is a randomised controlled study aiming to evaluate the implementation of a website ('Small Steps') to support the modification of participants' time-use behaviour to reduce the risk factors for dementia. 'Small Steps' website provides the tools for this with a visual representation of the participant's current use of time and allowing manipulation to demonstrate how small lifestyle changes may improve and meet sleep and physical activity needs. Participants will be assisted to make changes to current behaviours with the aim to reduce the time they spend sitting (sedentary behaviour), increase physical activity, and improve sleep duration and quality. Participants (aged 65 or older) will be randomly allocated to one of two groups, the 'Extended Program' (intervention) group or the 'Condensed Program' (control) group. There are 3 phases (Introductory, Maintenance and Follow-Up; each 12-weeks long) to this program and in total the program is 36-weeks long. Participants will use a tailored website to help support them in making progressive changes over the first 12 weeks. They will then try to maintain these behaviour changes for as long as possible. There will be in-person health testing during each phase and information about sleep habits, sleep quality, and motivation will be assessed using online surveys. Physical activity levels and sleep duration will also be assessed.

Начало: 03.04.2024 Край: 31.01.2027 Възраст: от 65 г. Превенция

Australia University of South Australia NCT06291909

Активно (без набиране) Фаза 3

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Hypophosphatasia

The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.

Начало: 02.04.2024 Край: 29.02.2028 Възраст: 2–11 г. Лечение

Argentina, Australia, Canada +4 Alexion Pharmaceuticals, Inc. NCT06079372

Активно (без набиране) Фаза 1/2

A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)

Bladder Cancer

Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving intismeran autogene (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery. Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells. The goals of this study are to learn if people who receive intismeran autogene and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and EV, and if people tolerate them.

Начало: 28.03.2024 Край: 20.10.2031 Възраст: от 18 г. Лечение

Australia, Canada, Chile +13 Merck Sharp & Dohme LLC NCT06305767

Активно (без набиране) Фаза 1

A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years

Herpes Zoster

This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.

Начало: 27.03.2024 Край: 30.09.2025 Възраст: 50–70 г. Превенция

Australia Guangzhou Patronus Biotech Co., Ltd. NCT06335849

Активно (без набиране) Фаза 2

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

The goal of this study is to learn if emvistegrast (formerly GS-1427) is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with emvistegrast with participants treated with placebo. The primary objective of this study is to assess the efficacy of emvistegrast, compared with placebo control, in achieving clinical response at Week 12.

Начало: 27.03.2024 Край: 01.04.2028 Възраст: 18–75 г. Лечение

Australia, Belgium, Canada +18 Gilead Sciences NCT06290934

Активно (без набиране) Фаза 1/2

Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

Human Papillomavirus Infection

This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

Начало: 27.03.2024 Край: 30.06.2026 Възраст: 25–55 г. Лечение

Australia, Kenya, Mexico +1 Antiva Biosciences NCT06491446

Активно (без набиране) Фаза 3

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

HIV-1-infection

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.

Начало: 25.03.2024 Край: 01.12.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +11 Gilead Sciences NCT06333808

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