Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

Официальное название

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

Обзор

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Подробное описание

This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).

Вмешательства

• Препарат Brelovitug (BJT-778)
  Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.
• Препарат Bulevirtide
  Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.

Первичные конечные точки

• Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND]) [Срок оценки: Week 24]

Вторичные конечные точки (12)

• Incidence and severity of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to Week 96]
• Proportion of participants who permanently discontinue treatment due to an adverse event [Срок оценки: Up to Week 96]
• Change from baseline in serum total bile salts [Срок оценки: Up to Week 96]
• Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND) [Срок оценки: Up to Week 96]
• Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96. [Срок оценки: Up to Week 96]
• Proportion of participants achieving undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96. [Срок оценки: Up to Week 96]
• Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96. [Срок оценки: Up to Week 96]
• Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND) [Срок оценки: Up to Week 96]
• Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96. [Срок оценки: Up to Week 96]
• 11. Proportion of participants achieving normal ALT with undetectable HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96 [Срок оценки: Up to Week 96]
• Change from baseline in HDV RNA [Срок оценки: Up to Week 96]
• Change from baseline in ALT levels [Срок оценки: Up to Week 96]

Критерии участия

Критерии включения

• Willing and able to provide written informed consent.
• Male or female, ≥18 years of age at Screening.
• Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
• Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
• HDV RNA ≥100 IU/mL at Screening.

Критерии исключения

• Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
• Known history of immune-complex disease.
• Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
• Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
• History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 10 центров

• CHU de Bordeaux — Bordeaux
• Clermont-Ferrand University Hospital — Clermont-Ferrand
• Hospital Beaujon — Clichy
• Henri Mondor University Hospital (APHP) — Créteil
• CHU Grenoble Alpes Hopital Nord Michallon — Grenoble
• CHU Limoges — Limoges
• Hospital De La Croix Rousse — Lyon
• Hopital Saint-Eloi — Montpellier
• … и ещё 2 центра

Румыния · 6 центров

• Centrul Medical Unirea S.R.L — Iași
• National Institute Of Infectious Diseases Prof. Dr. Matei Bals — Bucharest
• Fundeni Clinical Institute — Bucharest
• Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes — Bucharest
• National Institute Of Infectious Diseases Prof. Dr. Matei Bals — Bucharest
• Spitalul Clinic de Boli Infectioase Constanta — Constanța

Великобритания · 6 центров

• Castle Hill Hospital — Cottingham
• Cardiff and Vale University Health Board — Cardiff
• Barts Health NHS Trust — London
• King's College Hospital NHS Foundation Trust — London
• Chelsea and Westminster Hospital — London
• Manchester University Nhs Foundation Trust — Manchester

Германия · 4 центра

• University Hospital of Dusseldorf — Düsseldorf
• Goethe University Frankfurt — Frankfurt
• Medizinische Hochschule Hannover — Hanover
• Universitatsmedizin Rostock — Rostock

Чехия · 3 центра

• Fakultni Nemocnice Brno (University Hospital Brno) — Brno
• Klin Med Ltd. (KLIN MED s.r.o.) — Prague
• Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental — Prague

Испания · 3 центра

• Vall d'Hebron Hospital — Barcelona
• Hospital Clinic I Provincial De Barcelona — Barcelona
• Hospital Universitario Ramon y Cajal — Madrid

Австрия · 2 центра

• Medical University of Graz — Graz
• Medizinische Universitat Innsbruck — Innsbruck

Италия · 1 центр

• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Идентификаторы

NCT: NCT07454837 · BJT-778-303

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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