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Активно (без набиране) Фаза 3 2023-509912-27-00

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metabolic Dysfunction-Associated Steatotic Liver Disease(MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Спонсор: 89bio Inc.

Налично на: БГ
Обобщение
Trial status: Authorised 1_Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, 2_Percent Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, 3_Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Up to Month 36, 4_Absolute change from baseline in ELF score at 52 weeks 1_Proportion of participants achieving the co-primary endpoints measured at 52 weeks of: _ Improvement in fibrosis by ≥1 stage without worsening of steatohepatitis -resolution of steatohepatitis without worsening of fibrosis
Описание
1_Change From Baseline in Liver Fat as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 52, 2_Percent Change from Baseline in Alanine Aminotransferase (ALT) at Week 52 and Month 36, 3_Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events Up to Month 36, 4_Absolute change from baseline in ELF score at 52 weeks
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 260 participants
Интервенции
Pegozafermin
Drug
Placebo for pegozafermin. combined integral administration device: pre-filled syringe - please refer to the IMPD pegozafermin section 3.2.p.7 container closure system for detailed description.
Drug
Места на провеждане 10
Австрия (1)
Белгия (1)
България (1)
Чехия (1)
Франция (1)
Германия (1)
Италия (1)
Нидерландия (1)
Полша (1)
Испания (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
30.07.2024
Регистрационен номер
2023-509912-27-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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