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Набира участници Фаза 2 NCT06613698

A Study to Investigate the Safety and Efficacy of GSK4532990 Compared With Placebo in Adult Participants Aged 18 to 70 Years With Alcohol-related Liver Disease

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Liver Diseases, Alcoholic

Спонсор: GlaxoSmithKline

Налично на: БГ
Обобщение
The goal of this study is to assess the safety and efficacy of GSK4532990 in participants with alcohol-related liver disease.
Кой може да участва
Inclusion Criteria: * Capable of giving signed informed consent prior to the performance of any study-specific procedures. * Able and willing to comply with all study assessments and adhere to the protocol schedule of activities. * In the opinion of the investigator, there is a history of alcohol consumption compatible with either ALD or Met ALD. * A female participant is eligible to participate after meeting additional pre-defined criteria. * Participants must meet predefined stable use requirements of concomitant medications based on study criteria. * Participant has advanced chronic liver disease Exclusion Criteria: * Meeting any definition of organ system failure as defined by the North American Consortium for Study of End-stage Liver Disease (NACSELD) * Exceeding pre-defined biochemical parameters for Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline Phosphatase (ALP), Platelets, International normalised ratio (INR), Albumin, estimated glomerular filtration rate (eGFR), Urine albumin-creatinine ratio (UACR) or Glycosylated Hemoglobin (HbA1c). Other primary causes of liver disease based on study criteria. * Current malignancy (except for basal cell carcinoma or uterine carcinoma-in-situ) at screening. Participants under evaluation for possible malignancy at screening are not eligible. * Prior organ transplant or current listing or active consideration for organ transplant during the screening period (except for corneal transplants). * Chronic or acute, including partial, known portal vein thrombosis. * Prior transjugular intrahepatic portosystemic shunt (TIPSS) insertion. * Any acute cardiovascular event including myocardial infarction, unstable angina, symptomatic heart failure, or cerebrovascular accident in the 6 months prior to screening. * Poorly controlled hypertension * Clinical suspicion of rhabdomyolysis during the screening period * Clinical suspicion of a bleeding episode during the screening period related to portal hypertension and/or low blood fibrinogen level. * Body Mass Index (BMI) \>35 kg/m2 at screening * Any liver-related clinical event that started (onset) \<8 weeks prior to Baseline (D1).
Места на провеждане 17
Argentina (1)
GSK Investigational Site
Buenos Aires
US GSK Clinical Trials Call Center
Австралия (1)
GSK Investigational Site
Adelaide , South Australia
US GSK Clinical Trials Call Center
Канада (1)
GSK Investigational Site
Calgary , Alberta
US GSK Clinical Trials Call Center
Дания (1)
GSK Investigational Site
Esbjerg
US GSK Clinical Trials Call Center
Франция (1)
GSK Investigational Site
Angers
US GSK Clinical Trials Call Center
Гърция (1)
GSK Investigational Site
Athens
US GSK Clinical Trials Call Center
Италия (1)
GSK Investigational Site
Bergamo
US GSK Clinical Trials Call Center
Япония (1)
GSK Investigational Site
Chiba
US GSK Clinical Trials Call Center
Mexico (1)
GSK Investigational Site
DF
US GSK Clinical Trials Call Center
Полша (1)
GSK Investigational Site
Katowice
US GSK Clinical Trials Call Center
South Africa (1)
GSK Investigational Site
Johannesburg
US GSK Clinical Trials Call Center
Южна Корея (1)
GSK Investigational Site
Ansan
US GSK Clinical Trials Call Center
Испания (1)
GSK Investigational Site
Barcelona
US GSK Clinical Trials Call Center
Швеция (1)
GSK Investigational Site
Stockholm
US GSK Clinical Trials Call Center
Турция (1)
GSK Investigational Site
Kocaeli , İzmit
US GSK Clinical Trials Call Center
Великобритания (1)
GSK Investigational Site
Bristol
US GSK Clinical Trials Call Center
САЩ (1)
GSK Investigational Site
Chandler , Arizona
US GSK Clinical Trials Call Center
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
27.09.2024
Крайна дата
07.03.2028
Регистрационен номер
NCT06613698
Източник
anzctr
Запитване за медицински туризъм

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