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Recruiting Phase 3

A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.

Начало: 11.06.2025 Край: 01.12.2031 Възраст: от 18 г. Treatment

Argentina, Australia, Austria +18 BeOne Medicines NCT06943872

Recruiting Phase 1

Study of HX15001 in Adult Healthy Volunteers.

Healthy Volunteers

This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants. The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9). The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.

Начало: 11.06.2025 Край: 30.09.2026 Възраст: 18–55 г. Treatment

Australia Helixon Biotechnology (Suzhou) Co., Ltd NCT06999720

Recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Bipolar-I Disorder With Mania or Mania With Mixed Features

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Начало: 11.06.2025 Край: 01.11.2026 Възраст: 18–65 г. Treatment

Argentina, Australia, Bulgaria +5 Bristol-Myers Squibb NCT06951698

Recruiting Phase 1/2

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed

Gastrointestinal Neoplasms

This study will check how well a new medicine, GSK5764227, works, how safe it is and how the body handles it in participants all around the world with advanced inoperable or metastatic gastrointestinal cancer who have previously received treatment.

Начало: 11.06.2025 Край: 23.06.2028 Възраст: от 18 г. Treatment

Australia, Belgium, Brazil +11 GlaxoSmithKline NCT06885034

Recruiting Phase 3

A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

Healthy

The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.

Начало: 11.06.2025 Край: 24.10.2031 Възраст: 2–17 г.

Indonesia, Malaysia, Philippines +4 Merck Sharp & Dohme LLC NCT07013487

Recruiting

Restrospective Analysis of MACE in Patients Treated With Drug-elluting Balloons.

Coronary Arterial Disease (CAD) Restenosis, Coronary Bifurcation Coronary Disease

Retrospective analysis of data collected in an institutional database of coronary interventions with use of drug-eluting balloons, with a prospective follow-up for major adverse cardiovascular events and living status.

Начало: 10.06.2025 Край: 01.03.2036 Възраст: от 18 г.

Canada Olivier F. Bertrand NCT06972225

Recruiting

Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics

Open Abdomen Mechanical Ventilation

Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an "open abdomen". To limit the risk of further widening of their wounds, surgeons can use AbClo, which is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims: * To assess whether the abdominal binding device causes changes in the pressure compressing the lungs, the lung volume, and the function of the lungs. * To assess whether adjusting the breathing machine can mitigate such negative changes. Participants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.

Начало: 10.06.2025 Край: 01.06.2026 Възраст: от 18 г.

Canada Unity Health Toronto NCT07154589

Recruiting Phase 1

Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension

Open Angle Glaucoma (OAG) Ocular Hypertension (OH)

The goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.

Начало: 10.06.2025 Край: 15.11.2026 Възраст: от 18 г. Treatment

Australia PolyActiva Pty Ltd NCT06964061

Recruiting Phase 3

REVEAL: A Phase 3 Study of ION582 in Angelman Syndrome

Angelman Syndrome

The purpose of this study is to evaluate the efficacy and safety of ION582 in children and adults with Angelman syndrome caused by a deletion or mutation of the UBE3A gene.

Начало: 10.06.2025 Край: 01.04.2030 Възраст: 2–50 г. Treatment

Australia, Canada, Germany +9 Ionis Pharmaceuticals, Inc. NCT06914609

Recruiting Phase 3

A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

Endometrial Cancer

The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample. In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \[or docetaxel, if participants cannot take paclitaxel\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs). In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment. The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.

Начало: 10.06.2025 Край: 01.11.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +19 BioNTech SE NCT06340568

Recruiting Phase 1

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort

Chronic Kidney Disease

This study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of AZD4248 administered as an oral solution and intravenous (IV) infusion. Additionally, the study investigates the non-interventional feasibility of home measurement of serum creatinine in participants with diabetic kidney disease (DKD).

Начало: 09.06.2025 Край: 18.06.2026 Възраст: 18–75 г.

United States AstraZeneca NCT07024823

Recruiting Phase 2

A Study to Assess Adverse Events and Effectiveness of IntraVenous Infusions of ABBV-CLS-628 in Adult Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Autosomal Dominant Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is the most common genetic cause of kidney disease that causes fluid-filled cysts to develop in the kidneys. The purpose of this study is to assess the safety and efficacy of ABBV-CLS-628 for the treatment of ADPKD in adult participants. ABBV-CLS-628 is an investigational drug being developed for the treatment of ADPKD. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Around 240 adult participants with ADPKD will be enrolled at approximately 100 sites worldwide. Participants will receive IntraVenous ABBV-CLS-628 or placebo every 4 weeks for 92 weeks. Participants will be followed for up to 15 weeks. 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: 09.06.2025 Край: 01.08.2029 Възраст: 18–55 г. Treatment

Australia, Belgium, France +8 AbbVie NCT06902558

Recruiting Phase 3

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

Bronchiectasis

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.

Начало: 09.06.2025 Край: 12.10.2028 Възраст: от 12 г. Treatment

Argentina, Australia, Belgium +40 Boehringer Ingelheim NCT06872892

Recruiting Phase 3

A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old (BRAVE)

Friedreich Ataxia

In this study, researchers will learn more about the effects and safety of BIIB141, also known as omaveloxolone or SKYCLARYS®. This drug has been approved, or made available for doctors to prescribe, for people with Friedreich's Ataxia (FA) who are at least 16 years old. But, it is not yet available for children and teens with FA who are younger than 16 years old. The main objective of this study is to learn how BIIB141 works in the body and about its safety in children and teens who are 2 to 15 years old. The main questions researchers want to answer in this study are: * How does BIIB141 affect the participants' FA symptoms balance and stability? * How many participants have medical problems during the study? * Are there any changes in the participants' overall health during the study? * Are there any changes in the participants' heart health? * Are there any changes in how the participants move through puberty? Puberty is the time in someone's life when their body changes from a child to an adult. Researchers will also learn more about: \- How the body processes BIIB141 in children and teens This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * There are 2 parts in this study. During Part 1, participants will take either BIIB141 or a placebo once a day. * In Part 1, participants will take BIIB141 or the placebo in a study research center on Day 1, and then at in-person visits at Week 4, Week 12, Week 26, and Week 52. On all other days, they will take BIIB141 or the placebo at home. Part 1 lasts up to 52 weeks. * During Part 2, participants from Part 1 will either continue taking BIIB141 or start it if they were taking the placebo. Part 2 will last up to 104 weeks. * In Part 1, participants will have up to 10 visits to their study research center and a phone call at Week 2. In Part 2, participants will have visits at Weeks 4, 8,12, 26, and every 26 weeks after that until they leave the study, and a phone call at Week 2. There will be a final phone call to check on the participants' health 31 days after their last dose. * Each participant will be in the study for up to about 3 years

Начало: 09.06.2025 Край: 22.11.2029 Възраст: 2–15 г. Treatment

Australia, Brazil, Canada +11 Biogen NCT06953583

Recruiting

Post-operative Radiotherapy Omission in Selected Patients With Early Breast Cancer Trial International VErsion (PROSPECTIVE)

Breast Cancer Breast Cancer Female

The PROSPECTIVE trial aims to find out if using the results of Magnetic Resonance Imaging (MRI) for early breast cancer can select people to not have radiotherapy and still have a low chance of the cancer coming back after surgery. The main question it aims to answer is: \* Will cancer come back in the same breast as the original cancer in patients who have surgery for their breast cancer, but who don't have radiotherapy afterwards because the results of an MRI before surgery showed favourable characteristics for not having radiotherapy.

Начало: 06.06.2025 Край: 01.06.2039 Възраст: от 50 г. Other

Australia, United States Breast Cancer Trials, Australia and New Zealand NCT06445738

Recruiting

Evaluation of Combined Sensitising and Hypomethylating Therapy Outcomes in AML PDX

AML - Acute Myeloid Leukemia

The goal of this observational study is to develop new ways to test new drug combinations to kill tumour cells, in patients with acute myeloid leukemia (AML). The main questions it aims to answer are: * Are there new ways to speed up discovery of better treatments for AML patients using AML cells from individual from patients in special mice that can accept human tissue? * Do these mice show treatment responses that are similar to the individual AML patient from whom cells were derived? Participants with AML who are taking standard of care treatment of venetoclax and azacitidine will be asked to donate blood and bone marrow samples for this study.

Начало: 06.06.2025 Край: 01.03.2030 Възраст: от 18 г.

Australia Clinical Hub for Interventional Research (CHOIR) NCT06782971

Recruiting Phase 2

A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome

Myelodysplastic Syndromes

The goal of this clinical trial is to determine if momelotinib is safe and effective for people with low-risk myelodysplastic syndromes (LR-MDS). The trial will also examine how the body processes the drug. The study is comprised of two parts: Part 1: Participants will receive different doses of momelotinib to find the best dose by evaluating effectiveness in improving red blood cell transfusion requirements and safety. Part 2: Participants will receive dose selected from Part 1 to assess its impact on improving red blood cell transfusion requirements and safety in LR-MDS.

Начало: 05.06.2025 Край: 29.12.2027 Възраст: от 18 г.

Canada, France, Germany +6 GlaxoSmithKline NCT06847867

Recruiting Phase 2

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

Multiple Sclerosis Spasticity

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

Начало: 05.06.2025 Край: 09.06.2027 Възраст: 18–70 г. Treatment

Australia, Canada, Czechia +4 Celgene NCT06782490

Recruiting Phase 2

Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

Acute Leukemia of Ambiguous Lineage B Acute Lymphoblastic Leukemia

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged \[R\]) or without a KMT2A gene rearrangement (KMT2A-germline \[G\]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

Начало: 05.06.2025 Край: 31.12.2028 Възраст: до 365 г.

Puerto Rico, United States National Cancer Institute (NCI) NCT06317662

Recruiting Phase 3

A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event

Cardiovascular Disease

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.

Начало: 04.06.2025 Край: 26.10.2029 Възраст: от 18 г. Treatment

Argentina, Brazil, Bulgaria +32 AstraZeneca NCT07000357

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