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NCT ID: NCT05920408 Terminated - Clinical trials for Advanced Solid Tumours

Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours

Start date: April 11, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.

NCT ID: NCT05705167 Terminated - COVID-19 Clinical Trials

Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care

NEREIDA
Start date: April 19, 2023
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate efficacy of plitidepsin in pre-specified groups of immunocompromised patients with symptomatic COVID-19 requiring hospital care versus control in terms of mortality.

NCT ID: NCT05643573 Terminated - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05493293 Terminated - Focal Onset Seizure Clinical Trials

Extension Study to Evaluate the Safety and Tolerability of NBI-921352 When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Start date: November 9, 2022
Phase: Phase 2
Study type: Interventional

This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.

NCT ID: NCT05479058 Terminated - Ulcerative Colitis Clinical Trials

A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission

CAPYBARA
Start date: July 26, 2022
Phase: Phase 3
Study type: Interventional

Participants who are in clinical remission on 200 mg filgotinib once daily (q.d.) for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), are planned to be rolled over and randomized in this study. The primary objective of this study is to evaluate the efficacy of filgotinib in participants in stable clinical remission on 200 mg filgotinib q.d. for whom the dose was decreased to 100 mg q.d. compared to participants remaining on 200 mg q.d.

NCT ID: NCT05442775 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)

COURAGE OLE
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)

NCT ID: NCT05430555 Terminated - Clinical trials for Advanced Solid Tumors

A Phase 1/ 2, First-in-Human, Open-Label, Accelerated-Titration, Two-Part Clinical Trial of TK-8001 in Patients With HLA-A*02:01 Genotype and Advanced-Stage/ Metastatic MAGE-A1+ Solid Tumors

IMAG1NE
Start date: July 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to determine the safety, tolerability and anti-tumoral activity of autologous T cells transduced with a T cell receptor specific for MAGE-A1 in eligible patients with advanced solid tumors.

NCT ID: NCT05429762 Terminated - Neoplasm Clinical Trials

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

TusaRav-QT
Start date: October 3, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

NCT ID: NCT05392959 Terminated - Clinical trials for Diabetes Mellitus, Type 2

Effect of the Antidiabetic Drug Dapagliflozin on the Coronary Macrovascular and Microvascular Function in Type 2 Diabetic Patients

DAPAMICRO
Start date: June 6, 2022
Phase: Phase 4
Study type: Interventional

Cardiovascular events remain a major driver of morbidity and mortality in patients with type 2 diabetes mellitus. Diffuse coronary atherosclerosis, combined with impairment of the microcirculation are frequent even in asymptomatic patients and can lead to unfavourable outcomes. In recent years, novel classes of antidiabetic drugs have been introduced, with salutary effects on cardiovascular outcomes of diabetic patients. The sodium-glucose linked transporter 2 (SGLT2) inhibitors - gliflozins - bind to the SGLT2 receptors of the proximal tubule of the nephron and cause glycosuria. They have been shown to have favourable cardiovascular effects by reducing deaths from cardiovascular causes in type 2 diabetic patients. Moreover, dapagliflozin reduces hospitalisation for heart failure in type 2 diabetic heart failure patients with and without reduced ejection fraction and reduces cardiovascular death and all causes mortality in those with reduced ejection fraction. It is currently unknown if this is mediated by improvement of coronary physiology both at the level of the epicardial coronary arteries as well as the coronary microcirculation. The purpose of the study is to explore the impact of dapagliflozin on the coronary and microcirculatory function of type 2 diabetic patients.

NCT ID: NCT05321524 Terminated - Biliary Atresia Clinical Trials

Obeticholic Acid in Pediatric Subjects With Biliary Atresia

CARE
Start date: July 1, 2015
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In addition, a change in vitamin A and D levels, and where possible the degree of change in liver stiffness, will be assessed during the OLE.