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Активно (без набиране) Фаза 3

A Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation

Atrial Fibrillation

The purpose of this study is to evaluate if milvexian is at least as effective as apixaban for reducing the risk of the composite stroke and non-central nervous system (CNS) systemic embolism.

Начало: 11.04.2023 Край: 31.10.2026 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +34 Janssen Research & Development, LLC NCT05757869

Активно (без набиране) Фаза 3

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

Chronic Kidney Disease CKD Cardiac Disease Cardiopulmonary Bypass

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.

Начало: 06.04.2023 Край: 17.02.2027 Възраст: 18–90 г. Лечение

Argentina, Australia, Brazil +17 Alexion Pharmaceuticals, Inc. NCT05746559

Активно (без набиране) Фаза 2

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab

Plasma Cell Myeloma

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Начало: 05.04.2023 Край: 30.11.2026 Възраст: от 18 г. Лечение

Australia, Brazil, Chile +14 Sanofi NCT05669989

Активно (без набиране) Фаза 2

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy, and to characterize the PK of isatuximab in combination with carfilzomib and dexamethasone after manual and On Body Delivery System (OBDS) administration. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery methods of SC isatuximab.

Начало: 05.04.2023 Край: 12.05.2028 Възраст: от 18 г. Лечение

Australia, Brazil, China +4 Sanofi NCT05704049

Активно (без набиране) Фаза 3

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

Biochemically Recurrent Prostate Cancer

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen \[PSMA\] positron emission tomography \[PET\]) /computed tomography \[CT\]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: * take blood and urine samples. * measure PSA and testosterone levels in the blood samples * do physical examinations * check the participants' overall health * examine heart health using electrocardiogram (ECG) * check vital signs * check cancer status using PSMA PET/CT scans, CT, MRI and bone scans * take tumor samples (if required) * ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

Начало: 03.04.2023 Край: 29.03.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +17 Bayer NCT05794906

Активно (без набиране) Фаза 1/2

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.

Alzheimer Disease

A Clinical Trial to Assess Pharmacokinetic Profiles and Safety of IVL3003

Начало: 01.04.2023 Край: 13.11.2025 Възраст: 18–55 г. Лечение

Australia Inventage Lab., Inc. NCT05345509

Активно (без набиране) Фаза 3

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Начало: 29.03.2023 Край: 31.08.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +18 Janssen Research & Development, LLC NCT05572515

Активно (без набиране)

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

Atrial Fibrillation

The goal of any novel design or therapeutic strategy to treat atrial fibrillation is to restore normal sinus rhythm and to reduce or eliminate the symptoms due to rapid atrial response. Boston Scientific has developed the FARAPULSE™ Pulsed Field Ablation therapy that uses irreversible electroporation to induce cell death. This Registry is intended to obtain purely observational and prospective real world data and to provide continued evidence on the safety and effectiveness when the FARAPULSE™ pulsed field ablation System is used per hospitals' standard of care.

Начало: 24.03.2023 Край: 15.08.2027 Възраст: от 18 г.

Australia, Belgium, Czechia +16 Boston Scientific Corporation NCT05501873

Активно (без набиране) Фаза 3

A Study of TAR-200 in Combination With Cetrelimab or TAR-200 Alone Versus Intravesical Bacillus Calmette-Guérin (BCG) in Participants With BCG-naïve High-risk Non-muscle Invasive Bladder Cancer (HR-NMIBC)

Bladder Cancer

The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS), between TAR-200 plus cetrelimab (Group A) and TAR-200 alone (Group C) versus intravesical BCG (Group B).

Начало: 23.03.2023 Край: 18.09.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +17 Janssen Research & Development, LLC NCT05714202

Активно (без набиране) Фаза 1

A Single Ascending Doses Phase I Study to Evaluate the Safety and Pharmacokinetics of RBD4059 in Healthy Subjects

Healthy Volunteers

This is a Randomized, Single-blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of Subcutaneously Administered RBD4059 in Healthy Subjects. The study will be performed in single ascending dose (SAD) phase in healthy subjects. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information and PK/PD data in each cohort. RBD4059, a GalNAc conjugated siRNA, is an FXI-targeted new molecular entity independently developed by Ribo using its proprietary siRNA delivery system - RIBO-GalSTARTM.

Начало: 21.03.2023 Край: 01.12.2025 Възраст: 18–65 г. Лечение

Australia Suzhou Ribo Life Science Co. Ltd. NCT05653037

Активно (без набиране) Фаза 1

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of XmAb24306 in Combination With Cevostamab in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with cevostamab in participants with relapsed/refractory multiple myeloma (R/R MM) who have received a minimum of three prior treatments, including at least one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one anti-CD38 monoclonal antibody.

Начало: 21.03.2023 Край: 18.11.2026 Възраст: от 18 г. Лечение

Australia, Denmark, Greece +4 Genentech, Inc. NCT05646836

Активно (без набиране) Фаза 1

ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer

HER2 Mutant Non-small Cell Lung Cancer HER2-positive Metastatic Breast Cancer HER2 Gene Mutation HER2 Amplification

The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

Начало: 20.03.2023 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia, France, Italy +4 Enliven Therapeutics NCT05650879

Активно (без набиране) Фаза 3

A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)

HIV Infection

The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.

Начало: 17.03.2023 Край: 06.09.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Canada +12 Merck Sharp & Dohme LLC NCT05766501

Активно (без набиране) Фаза 3

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Researchers are looking for new ways to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL and SLL are types of blood cancer. Researchers want to know if people who take nemtabrutinib compared to those who take the standard treatments in this study will live longer without their cancer growing, spreading or returning (progression free survival).

Начало: 16.03.2023 Край: 17.03.2031 Възраст: от 18 г. Лечение

Australia, Brazil, Bulgaria +18 Merck Sharp & Dohme LLC NCT05624554

Активно (без набиране) Фаза 2

Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

Pulmonary Hypertension Chronic Obstructive Pulmonary Disease

Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.

Начало: 16.03.2023 Край: 07.10.2029 Възраст: 40–85 г. Лечение

Argentina, Australia, Belgium +15 Merck Sharp & Dohme LLC NCT05612035

Активно (без набиране) Фаза 1

A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of IOS-1002 Administered Alone and in Combination With Pembrolizumab, a PD-1 Monoclonal Antibody in Advanced Solid Tumors

Solid Tumor, Adult

The goal of this clinical trial is to learn about IOS-1002 in patients with solid tumors. The main questions it aims to answer are: * To determine the safety and tolerability of various doses of IOS-1002 administered alone and/or in combination with KEYTRUDA® (pembrolizumab) in a single dose escalation scheme * To determine the safety, tolerability and efficacy of a selected dose of IOS-1002 administered every 2 weeks alone and in combination with a PD-1 Antibody The study will be conducted in 3 parts: * Part A (Phase 1a, monotherapy and combination therapy dose escalation): IOS-1002 alone and IOS-1002 plus PD-1 mAb in patients with advanced solid tumors * Part B (Phase 1b, monotherapy cohort expansion): IOS-1002 alone in patients with advanced solid tumors * Part C (Phase 1b, combination therapy cohort expansion): IOS-1002 plus PD-1 mAb in patients with advanced solid tumors.

Начало: 15.03.2023 Край: 01.07.2026 Възраст: от 18 г. Лечение

Australia ImmunOs Therapeutics AG NCT05763004

Активно (без набиране) Фаза 1/2

An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases

Lupus Nephritis Immunoglobulin A Nephropathy Membranous Nephropathy Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

The goal of this clinical study is to evaluate multiple dose levels of povetacicept in adults with immunoglobulin A (IgA) nephropathy (IgAN), primary membranous nephropathy (pMN), lupus-related kidney disease (lupus nephritis - LN), or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV) to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52-week treatment extension period. Participants with IgAN and pMN may also receive povetacicept for an additional 52 weeks, if eligible.

Начало: 15.03.2023 Край: 02.03.2028 Възраст: от 18 г. Лечение

Australia, Puerto Rico, South Korea +1 Alpine Immune Sciences, Inc. NCT05732402

Активно (без набиране) Фаза 3

Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Mixed Phenotype Acute Leukemia Myelodysplastic Syndrome

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

Начало: 15.03.2023 Край: 30.06.2026 Възраст: 6–21 г. Лечение

Australia, Canada, United States Children's Oncology Group NCT05457556

Активно (без набиране) Фаза 2

A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.

Начало: 15.03.2023 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +8 Hoffmann-La Roche NCT05775289

Активно (без набиране) Фаза 3

A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Primary Prevention of Atherosclerotic Cardiovascular Disease

CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.

Начало: 09.03.2023 Край: 16.04.2029 Възраст: 40–79 г. Превенция

Argentina, Australia, Belgium +36 Novartis Pharmaceuticals NCT05739383

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