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Набира участници Фаза 3 NCT06419374

A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Спонсор: 89bio, Inc.

Налично на: БГ
Обобщение
The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).
Кой може да участва
Key Inclusion Criteria: * Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF). * Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors. * Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis. * Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2). Key Exclusion Criteria: * Liver disorder other than MASH. * History or evidence of hepatic decompensation. * History or evidence of hepatocellular carcinoma. * Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus. * ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L). * Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening. Other protocol-defined inclusion and exclusion criteria may apply.
Места на провеждане 23
Argentina (1)
89bio Clinical Study Site
Buenos Aires
Австралия (1)
89bio Clinical Study Site
Adelaide
Белгия (1)
89bio Clinical Study Site
Brussels
Бразилия (1)
89bio Clinical Study Site
Barretos
България (1)
89bio Clinical Study Site
Gorna Oryahovitsa
Канада (1)
89bio Clinical Study Site
Calgary , Alberta
Франция (1)
89bio Clinical Study Site
Amiens
Германия (1)
89bio Clinical Study Site
Chemnitz
Hong Kong (1)
89bio Clinical Study Site
Hong Kong
Унгария (1)
89bio Clinical Study Site
Budapest
Израел (1)
89bio Clinical Study Site
Afula
Италия (1)
89bio Clinical Study Site
Bergamo
Mexico (1)
89bio Clinical Study Site
Chihuahua City
Нидерландия (1)
89bio Clinical Study Site
Amsterdam
Полша (1)
89bio Clinical Study Site
Katowice
WITHDRAWN
Puerto Rico (1)
89bio Clinical Study Site
Mayagüez
Сингапур (1)
89bio Clinical Study Site
Singapore
Южна Корея (1)
89bio Clinical Study Site
Bucheon-si
Испания (1)
89bio Clinical Study Site
Almería
Taiwan (1)
89bio Clinical Study Site
Chiayi City
Турция (1)
89bio Clinical Study Site
Bornova , İzmir
Великобритания (1)
89bio Clinical Study Site
Aberdeen
САЩ (1)
89bio Clinical Study Site
Birmingham , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
24.05.2024
Крайна дата
01.08.2031
Регистрационен номер
NCT06419374
Източник
anzctr
Запитване за медицински туризъм

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