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Recruiting Phase 3

A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial

Atherosclerotic cardiovascular disease (ASCVD)

Trial status: Authorised Time to the first occurrence of 4P-MACE from parent study baseline, Time to the first occurrence of 4P-MACE from OLE study baseline, Cumulative number of 4P-MACE over time from parent study baseline, Cumulative number of 4P-MACE over time from OLE study baseline, Observed value and change in Lp(a) from the parent study baseline, Observed value and change in Lp(a) from the OLE study baseline ● Occurrence of the followings: • Treatment Emergent Adverse Events (TEAEs) • Treatment Emergent Serious Adverse Events (TESAEs) • Treatment discontinuations due to TEAEs/TESAEs, ● TEAEs of special interest Observed value or change/shift from baseline in: • Safety laboratory measures • Vital signs

Начало: 18.08.2025 Възраст: от 18 г.

Austria, Belgium, Bulgaria +17 Novartis Pharma AG 2024-519870-38-00

Recruiting Phase 1/2

A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Metastatic

This study is testing narmafotinib, a type of drug called a focal adhesion kinase (FAK) inhibitor, when it is given in combination with 4 chemotherapy drugs in a regimen called FOLFIRINOX, to patients who have pancreatic cancer which has metastasised (spread). The study is being run in 2 parts. Part A will test increasing dose levels of narmafotinib in at least 3 people per dose at up to 4 dose levels to assess safety. Part B will test 2 of the dose levels from Part A in 20 people per dose, to select the best dose to take forward into future studies. Participants will take narmafotinib as oral capsules every day. They will also receive mFOLFIRINOX chemotherapy on Day 1 and and Day 15 of 28-day cycles.

Начало: 18.08.2025 Край: 01.07.2029 Възраст: от 18 г. Treatment

Australia, United States Amplia Therapeutics Limited NCT07026279

Recruiting Phase 3

A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)

Small-cell Lung Cancer Extensive Stage Small-cell Lung Cancer

The main objective of the study is to compare the efficacy of tarlatamab in combination with durvalumab, carboplatin and etoposide to the combination of durvalumab, carboplatin and etoposide on prolonging overall survival (OS).

Начало: 18.08.2025 Край: 15.07.2029 Възраст: 18–99 г. Treatment

Argentina, Australia, Austria +22 Amgen NCT07005128

Recruiting

Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)

Blood Culture Contamination Infection

Blood cultures (BCs) are a blood test to look for an infection. Two problems with the sample collection are contamination by germs outside of the blood and not collecting enough blood in the tube, resulting in unusable samples. Many patients requiring a BC also have a peripheral intravenous catheter ("catheter") but these are not normally used for blood sampling. This means that patients receive many painful needles for both catheter insertion and blood sampling. There is a needle-free blood collection device (PIVO Pro) which can be used with a catheter to collect a blood sample. The goal of the PIVO Trial is to see if using the PIVO Pro for blood culture sample collection will have a lower amount of contamination than the usual method of blood sample collection. Patients 18 and older at 3 emergency departments will be included. Research nurses will look for patients in emergency who need a blood culture sample taken and they will be asked if they want to be involved in the trial. Half of the participants will use the PIVO Pro to take their blood sample and half will have the usual way of collecting blood. Participants do not have to do anything specifically for the trial. Information about the blood collection and results of the blood culture will be collected from the medical records and recorded for the trial.

Начало: 18.08.2025 Край: 31.12.2026 Възраст: от 18 г. Other

Australia The University of Queensland NCT06806709

Recruiting Phase 1

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Acute Myeloid Leukemia Myelodysplastic Syndrome Myelodysplastic Syndrome/Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia +5

This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and/or effective in treating patients with AML and MDS.

Начало: 15.08.2025 Край: 01.06.2028 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06484062

Recruiting Phase 2

A New Intervention to Improve Function in Veterans With Anxiety and Depression

Anxiety and Depression

Anxiety and depression symptoms occur at high rates in Veteran populations and can significantly impact function, compromising the ability to work and to successfully form and maintain valued relationships. Several other symptoms commonly occur with anxiety and depression, including poor sleep quality and chronic pain. Since all these symptoms frequently occur together, they may have a common underlying biological basis. A single medication that could effectively treat all these symptoms would be ideal. Converging data suggest that pregnenolone is a promising pharmacological agent for treating multiple psychiatric symptoms and functional impairment. The investigators thus propose to conduct a clinical trial of pregnenolone in Veterans with anxiety and depression symptoms. Pregnenolone has minimal side effects, and the prior research demonstrates that pregnenolone is well-tolerated by Veterans. Treatment with pregnenolone could thus be an efficacious new therapeutic for Veterans experiencing depression, anxiety, poor sleep quality and chronic pain conditions.

Начало: 14.08.2025 Край: 30.09.2028 Възраст: 18–65 г.

United States VA Office of Research and Development NCT06188923

Recruiting Phase 1

A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)

Primary Central Nervous System (CNS) Lymphoma Secondary Central Nervous System Lymphoma

This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses of MB-CART19.1 to find the highest dose that causes few or mild side effects in participants.

Начало: 14.08.2025 Край: 01.08.2028 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT07137494

Recruiting Phase 2

An Open-label Study to Evaluate Safety, Tolerability, and Efficacy of CB03-154 in Subjects Diagnosed With Epilepsy

Focal Epilepsy

CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.

Начало: 14.08.2025 Край: 01.06.2029 Възраст: 18–70 г. Treatment

Australia Shanghai Zhimeng Biopharma, Inc. NCT07238868

Recruiting Phase 2

Open-label Extension Study in Participants With Early Alzheimer's Disease

Alzheimer's Disease

The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190). This new study is an extension of that parent study called an open-label extension (OLE). An OLE is a clinical trial where all participants receive the same study medicine. Participants must already be in study 219867 to be able to take part in this study. This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment \[MCI\] and mild dementia due to AD) who have completed the parent study.

Начало: 14.08.2025 Край: 08.12.2028 Възраст: 50–85 г. Treatment

Argentina, Australia, Canada +8 GlaxoSmithKline NCT07105709

Recruiting Phase 3

A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Immune Thrombocytopenic Purpura (ITP)

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, which are cells that help stop bleeding. This leads to a lower number of platelets, making it easier to bruise or bleed. The main aim of this study is to check how safe mezagitamab is and how well it is tolerated by adults with chronic primary ITP, if given over a longer time. Other aims are to learn how effective treatment with mezagitamab is and how the body processes it (called pharmacokinetics or PK) over a longer time. Participants of the following previous mezagitamab studies will be invited to join this continuation study: TAK-079-3002 and TAK-079-1004. In this continuation study, participants will receive mezagitamab when certain protocol criteria are met. During the study, participants will visit their study clinic several times.

Начало: 14.08.2025 Край: 29.07.2029 Възраст: от 18 г. Treatment

Australia, Bulgaria, China +11 Takeda NCT06948318

Recruiting Phase 2

FLudrocortisone Administration in Aneurysmal Subarachnoid Haemorrhage

Aneurysmal Subarachnoid Hemorrhage

A multi-centre, prospective, blinded, randomised clinical trial of fludrocortisone compared with placebo in patients presenting with aneurysmal subarachnoid haemorrhage. The study aim is to determine if early administration of enteral fludrocortisone in aneurysmal subarachnoid haemorrhage reduce death and dependency at six months.

Начало: 13.08.2025 Край: 31.07.2030 Възраст: от 18 г. Treatment

Australia, New Zealand The George Institute NCT06409364

Recruiting Phase 1

A Study to Test the Safety and Tolerability of SBO-154 in Patients With Advanced Solid Tumors.

Advanced Solid Tumors

This is a Phase 1 study of SBO-154 in patients with advanced cancers who are unable to tolerate or have not previously responded to standard therapy available in the country. The study involves multiple doses and takes place at several centers.

Начало: 12.08.2025 Край: 01.08.2030 Възраст: от 18 г. Treatment

Australia, India, United States Sun Pharma Advanced Research Company Limited NCT07042100

Recruiting

Mindfulness-Oriented Respiratory Distress Symptom Intervention for Lung Cancer

Symptom Cluster Breathlessness Coughing Fatigue Symptom +2

Lung cancer is the leading cause of cancer mortality, posing a critical public health challenge in both Hong Kong and global populations. Patients with lung cancer frequently experience a distressing symptom cluster characterized by breathlessness-driven respiratory distress, accompanied by persistent cough and fatigue, which collectively impose a substantial disease burden. While our research team leader previously developed and validated a multi-component Respiratory Distress Symptom Intervention (RDSI) in England, demonstrating clinical efficacy for lung cancer management, its impact on psychological distress (anxiety and depression) proved limited. This limitation may reflect insufficient integration of psychological components, a crucial consideration given the well-established bidirectional relationship between respiratory symptoms and psychological distress. Emerging evidence indicates that mindfulness interventions provide dual therapeutic benefits by improving patient adherence and effectively addressing both physical symptoms, such as breathlessness and fatigue, as well as psychological distress, including anxiety and depression. Meanwhile, current evaluation methodologies have mainly focused on behavioral data collection, such as self-reported questionnaires, to reflect the effect before and after the intervention. Neuroimaging data can help understand the brain mechanisms underlying breathlessness and elucidate the effectiveness of interventions, thereby improving intervention strategies.

Начало: 12.08.2025 Край: 30.07.2027 Възраст: от 18 г.

Hong Kong The Hong Kong Polytechnic University NCT07281300

Recruiting

The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors

Stroke Rehabilitation Robotic Rehabilitation

Walking rehabilitation after stroke is most effective during the first three months of recovery, but even in the chronic phase-beyond six months post-stroke-a significant number of patients still show potential for gait improvement. Robot-assisted rehabilitation is becoming increasingly common in clinical settings, with various design modes available. However, the effectiveness of new products in improving gait or motor function still requires further investigation. This study aims to evaluate the usability and therapeutic effects of a new end-effector exoskeleton robot system, HIWIN MRG-P110, for gait training in chronic stroke patients. The system uses foot pedal mechanisms to drive hip and knee movements for lower-limb training. Unlike its predecessor, this device allows adjustment of the active assistance ratio, encouraging users to engage in voluntary movement. It is designed for gait training in stroke patients and others with neurological impairments, but the usability and efficacy of this new training model remain to be verified. This clinical trial is a randomized, single-blind, prospective study enrolling 60 stroke patients who are 6 months to 3 years post-onset and have a Functional Ambulation Category (FAC) level of 0 to 3. The study will explore how patients with varying degrees of motor weakness learn to adapt to the "active-assistive mode" in terms of speed and perception. Participants will be randomly assigned to either the active-assistive mode group or the fully passive mode group. Both groups will receive 15 treatment sessions over 5 weeks. The study will compare the two groups in terms of: 1. Improvements in gait and balance immediately post-treatment and at 3-month follow-up 2. Changes in brain activity, as measured by functional near-infrared spectroscopy (fNIRS)

Начало: 12.08.2025 Край: 01.12.2026 Възраст: 18–80 г.

Taiwan National Taiwan University Hospital NCT07034521

Recruiting Phase 2

Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

COPD Acute Exacerbation

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Начало: 12.08.2025 Край: 01.05.2026 Възраст: 40–80 г. Treatment

Argentina, Australia, Georgia +3 Connect Biopharm LLC NCT06940154

Recruiting Phase 1/2

A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Advanced Solid Tumor

This study will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

Начало: 12.08.2025 Край: 01.10.2029 Възраст: от 18 г. Treatment

Australia, Belgium, Germany +4 BioNTech SE NCT07070232

Recruiting Phase 2

Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes

Type 2 Diabetes Mellitus (T2DM) Food Effect Safety and Tolerability Obesity

The goal of this intervention study is to evaluate the safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of MKP10241 in obese participants with and without T2DM in 3 parts. The main parameters it aims to answers are : 1. Does food effects the pharmacokinetic parameters following a single dose of MKP10241 in healthy participants? 2. Will multiple ascending doses of MKP10241 in obese participants with or without T2DM characterize changes in the plasma pharmacokinetic profile and pharmacodynamic effects? 3. What treatment emergent adverse events or discontinuation is experienced following single and multiple ascending doses of MKP10241 in healthy and obese participants with or without T2DM? This study will be compared against a placebo which is matched in appearance to MKP10241 at dosage strengths. Participants will: 1. Part 1: Take MKP10241 400 mg or Placebo on Day 1 and Day 8. Part 2: Take MKP10241 200 mg, 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 Part 3: Take MKP10241 300 mg and 400 mg or Placebo daily from Day 1 to Day 28 2. Visit the clinical research unit for dose administration, admission or follow up. 3. Will be monitored by the Safety Monitoring Committee.

Начало: 12.08.2025 Край: 17.04.2026 Възраст: 18–60 г. Treatment

Australia Mankind Pharma Limited NCT07098663

Recruiting Phase 1

A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes

Type 2 Diabetes

The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.

Начало: 11.08.2025 Край: 01.04.2027 Възраст: 18–59 г.

China Jiangsu HengRui Medicine Co., Ltd. NCT07032688

Recruiting Phase 3

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Neoplasms, Lung

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.

Начало: 11.08.2025 Край: 28.09.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Brazil +21 GlaxoSmithKline NCT07099898

Recruiting Phase 3

A Study to Evaluate the Long-Term Safety and Efficacy of JNT-517 in Participants With Phenylketonuria

Phenylketonuria (PKU)

The goal of this Phase 3, open-label extension study is to evaluate the long-term safety and efficacy of JNT-517 in participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 or JNT517-201. In this long-term extension (LTE) study, all adults (aged ≥18 years) who complete Study JNT517-101 will be randomized 1:1 to receive JNT-517 at 75 mg twice daily (BID) or 150 mg BID, regardless of their previous dose. Adolescent participants who complete Study JNT517-201 will receive the same JNT-517 dose of the cohort they were initially assigned to, either 75 mg BID or 150 mg BID.

Начало: 11.08.2025 Край: 01.02.2028 Възраст: от 12 г. Treatment

Australia, United States Otsuka Pharmaceutical Development & Commercialization, NCT06628128

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