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Набира участници Фаза 2

NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

Duchenne Muscular Dystrophy Exon 44 DMD

This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \

Начало: 22.02.2024 Край: 11.09.2026 Възраст: 4–14 г. Лечение

Australia, Canada, Japan +4 NS Pharma, Inc. NCT05996003

Набира участници Фаза 3

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

COPD (Chronic Obstructive Pulmonary Disease)

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Начало: 21.02.2024 Край: 07.03.2028 Възраст: 40–80 г. Лечение

Argentina, Australia, Brazil +32 AstraZeneca NCT06283966

Набира участници Фаза 3

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Limited Stage Small Cell Lung Cancer Small Cell Lung Cancer

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).

Начало: 20.02.2024 Край: 29.05.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Amgen NCT06117774

Набира участници Фаза 1/2

A Phase 1/2 Study of VX-670 in Adult Participants With Myotonic Dystrophy 1 (DM1)

Myotonic Dystrophy Type 1 (DM1)

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of VX-670 at different single and multiple doses in participants with DM1.

Начало: 20.02.2024 Край: 22.12.2026 Възраст: 18–64 г. Лечение

Australia, Belgium, Canada +7 Vertex Pharmaceuticals Incorporated NCT06185764

Набира участници Фаза 1/2

Pilot Study of MC in Paediatric Palliative Care

Palliative Care

The goal of this pilot study is to explore the feasibility and acceptability of a medicinal cannabis clinical trial into easing the symptoms of children undergoing palliative care for non-oncological conditions. The trial will evaluate the study design including recruitment strategy, medication tolerability, duration and outcomes to determine acceptability and feasibility for participating families. The data collected will then be used to design a full-scale multi-centre trial. Participants will be randomly allocated to receive one of two medicinal cannabis products. Neither the participants nor researchers will know the study drug allocation until the end of the trial.

Начало: 19.02.2024 Край: 01.12.2026 Възраст: 6–21 г. Поддържаща грижа

Australia Murdoch Childrens Research Institute NCT05615389

Набира участници Фаза 3

Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency

Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency

The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available. Patients will receive pharmaceutical grade P5P according to their normal oral P5P dosing regimen, as previously established by their physicians.

Начало: 16.02.2024 Край: 01.11.2026 Лечение

Australia, United States Medicure NCT04706013

Набира участници Фаза 3

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

B-Cell Non-Hodgkin Lymphoma (B-NHL)

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug versus Standard of Care (SOC) * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * Comparing the impact from the study drug versus SOC on quality-of-life and ability to complete routine daily activities

Начало: 15.02.2024 Край: 14.05.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +13 Regeneron Pharmaceuticals NCT06230224

Набира участници

PRIORITY-CONNECT 2 Pilot Trial

Liver Cancer Pancreas Cancer Oesophageal Cancer Gastric Cancer +1

The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications. Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care. The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.

Начало: 12.02.2024 Край: 22.12.2025 Възраст: от 18 г. Поддържаща грижа

Australia Surgical Outcomes Research Centre (SOuRCe) NCT06212700

Набира участници Фаза 1/2

A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors

Advanced Solid Tumors With KRAS G12C Mutations Solid Tumor, Adult Unresectable Solid Tumor Metastatic Solid Tumor +4

The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.

Начало: 12.02.2024 Край: 01.04.2028 Възраст: от 18 г. Лечение

Australia, South Korea, United States Frontier Medicines Corporation NCT06244771

Набира участници Фаза 1

A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors

Ovarian Cancer Solid Tumor

This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.

Начало: 09.02.2024 Край: 31.10.2027 Възраст: от 18 г. Лечение

Australia, United States OnCusp Therapeutics, Inc. NCT06234423

Набира участници Фаза 1/2

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

Glioblastoma Multiforme Astrocytoma, Grade IV

The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus \[CMV\]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.

Начало: 08.02.2024 Край: 01.01.2028 Възраст: от 18 г. Лечение

Australia Queensland Institute of Medical Research NCT06157541

Набира участници Фаза 1/2

A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers

Advanced or Metastatic Squamous Non-Small Cell Lung Cancer Advanced Head and Neck Squamous Cell Carcinoma Advanced Esophageal Squamous Cell Carcinoma Cervical Squamous Cell Carcinoma +3

This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers

Начало: 05.02.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia, Moldova, Singapore +2 Hummingbird Bioscience NCT05910827

Набира участници Фаза 3

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Follicular Lymphoma (FL)

Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. 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: 05.02.2024 Край: 01.11.2037 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +27 Genmab NCT06191744

Набира участници

Extracorporeal Carbon Dioxide Removal Using PrismaLung in Reducing Ventilator Induced Lung Injury

ARDS, Human

Lung protective ventilation with low tidal volumes and low driving pressure are known to reduce mortality in mechanically ventilated patients with acute respiratory failure. This reduction in mortality is known be due to reduction of ventilator induced lung injury that occurs due to high tidal volumes and high driving pressure. When receiving such mechanical ventilation, some patients develop hypercapnia and associated hypercapnic acidosis. Such patients have an increased risk of mortality. While the exact reasons for such increase in mortality is not known, it is recommended to minimise hypercapnia and hypercapnic acidosis during lung protective ventilation. Minimally invasive extracorporeal carbon dioxide removal (ECCO2R) devices are shown to reduce hypercapnia and hypercapnic acidosis. There are several devices that are currently available in the current clinical practice. However, the effect of these devices on reduction in ventilator induced lung injury is not clearly demonstrated. This study aims to assess the use of an ECCO2R device called Prismalung in reducing ventilator induced lung injury. PrismaLung is currently used in our intensive care unit. This assessment is done by measuring interleukins in bronchoalveolar lavage fluid and blood interleukin levels as well as clinical assessment including the reduction of driving pressure.

Начало: 05.02.2024 Край: 28.02.2028 Възраст: от 18 г.

Australia Peninsula Health NCT06321497

Набира участници

An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App

Hearing Loss

The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.

Начало: 05.02.2024 Край: 02.05.2027 Възраст: от 18 г. Фундаментална наука

Australia, Belgium, United States Cochlear NCT06098482

Набира участници Фаза 2

A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF

Cystic Fibrosis

This is the first-in-human study with RCT2100 and is designed to provide safety and tolerability data for future clinical studies.

Начало: 01.02.2024 Край: 31.12.2026 Възраст: 18–60 г. Лечение

France, Netherlands, New Zealand +2 ReCode Therapeutics NCT06237335

Набира участници Фаза 3

Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs)

Hemophilia B

The purpose of this study is to assess the risk of bleeding due to failure of expected pharmacological action of CSL222 in adults with severe or moderately severe hemophilia B with detectable pretreatment AAV5 Nabs.

Начало: 30.01.2024 Край: 02.04.2032 Възраст: от 18 г. Лечение

Australia, Canada, Hong Kong +9 CSL Behring NCT06003387

Набира участници

Current Practice of Ventilation Strategies in Children Undergoing General Anesthesia

Mechanical Ventilation Complication Pediatric ALL Pulmonary Complication Perioperative/Postoperative Complications

Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.

Начало: 29.01.2024 Край: 07.01.2026 Възраст: до 16 г.

Australia, Italy, Netherlands +1 Academisch Medisch Centrum - Universiteit van Amsterdam NCT06166706

Набира участници Фаза 1

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

Advanced Solid Tumors Colorectal Cancer

This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.

Начало: 25.01.2024 Край: 31.05.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +7 Vividion Therapeutics, Inc. NCT06004245

Набира участници

Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease

Parkinson's Disease (PD)

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting. ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain. All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years. Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.

Начало: 24.01.2024 Край: 01.05.2029 Възраст: от 18 г.

Australia, Canada, Denmark +5 AbbVie NCT06107426

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