A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

Официальное название

A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

Обзор

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

Подробное описание

Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms:

Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.

Вмешательства

• Препарат Brelovitug 300 mg
  Route of administration- Subcutaneous Injection
• Препарат Bulevirtide 2 mg and Brelovitug - 300 mg
  Route of Administration- Subcutaneous Injection

Первичные конечные точки

• Percentage of participants with a composite endpoint of virologic response and ALT normalization [Срок оценки: Week 48]

Вторичные конечные точки (12)

• Percentage of participants with treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 96 weeks]
• Percentage of participants who discontinue treatment due to an adverse event (AE) [Срок оценки: Up to 96 weeks]
• Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND [Срок оценки: Up 96 Weeks]
• Percentage of participants with HDV RNA <LLOQ [Срок оценки: Up to 96 Weeks]
• Percentage of participants with HDV RNA <LLOQ, TND [Срок оценки: Up to 96 Weeks]
• Percentage of participants with ALT normalization [Срок оценки: Up to 96 Weeks]
• Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND [Срок оценки: Up to 96 Weeks]
• Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ [Срок оценки: Up to 96 Weeks]
• Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND [Срок оценки: Up to 96 Weeks]
• Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) [Срок оценки: Up to 96 Weeks]
• Change from baseline in APRI (AST-to-platelet ratio index) [Срок оценки: Up to 96 Weeks]
• Change from baseline in CTP score in participants with cirrhosis [Срок оценки: Up to 96 Weeks]

Критерии участия

Критерии включения

• Willing and able to provide written informed consent
• Chronic HDV infection
• HDV RNA >500 IU/mL at Screening
• ALT >ULN at Screening
• Willing to take or already taking HBV neucleos(t)ide therapy.

Критерии исключения

• Pregnant or nursing females
• Unwilling to comply with contraception requirements during the study
• Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
• Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
• Solid organ or bone marrow transplantation
• Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Note - Other protocol-defined Inclusion/Exclusion criteria apply.

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 · 12 центров

• Hôpital Estaing — Clermont-Ferrand
• Hôpital Beaujon — Clichy
• University Hospital Henri Mondor - APHP — Créteil
• CHU Grenoble Alpes Hopital Nord Michallon — La Tronche
• Centre Hospitalier de Versailles _ Hopital Andre Magnot — Le Chesnay
• Lille Regional University Hospital Centre — Lille
• University Hospital Limoges — Limoges
• Hôpital de la Croix-Rousse — Lyon
• … и ещё 4 центра

Испания · 7 центров

• Hospital Universitario Torrecardenas — Almería
• Hospital Universitari Vall D Hebron — Barcelona
• Hospital Clinic Provincial De Barcelona — Barcelona
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario Virgen de la Victoria — Málaga
• Hospital Universitario Marqués de Valdecilla — Santander
• Hospital Universitario Álvaro Cunqueiro — Vigo

Великобритания · 6 центров

• Queen Elizabeth Hospital Birmingham — Birmingham
• Chelsea and Westminster Hospital NHS Foundation Trust — London
• North Manchester General Hospital — Manchester
• Hull University Teaching Hospitals — Cottingham
• Barts Health NHS Trust — London
• King's College Hospital NHS Foundation Trust — London

Чехия · 5 центров

• Fakultni Nemocnice Brno — Brno
• Fakultni Nemocnice Hradec Kralove — Hradec Králové
• Krajská nemocnice Liberec, a.s. — Liberec
• Institute For Clinical And Experimental Medicine — Prague
• Klin Med s.r.o. — Prague

Румыния · 5 центров

• National Institute Of Infectious Diseases — Bucharest
• Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes — Bucharest
• Centrul Medical Unirea S.R.L — Iași
• National Institute of Infectious Diseases Prof Dr Matei Bals — Bucharest
• Spitalul Clinic de Boli Infectioase Constanta — Constanța

Германия · 4 центра

• Goethe University Frankfurt — Frankfurt
• Rostock University Medical Center — Rostock
• Universitätsklinikum Düsseldorf — Düsseldorf
• Medizinische Hochschule Hannover — Hanover

Италия · 3 центра

• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan
• AOU Pisana - Cisanello — Pisa
• National Institute of Infectious Diseases Lazzaro Spallanzani — Roma

Швейцария · 3 центра

• Hôpitaux Universitaires — Geneva
• HOCH Health Ostschweiz — Sankt Gallen
• Universitätsspital Zürich — Zurich

Австрия · 2 центра

• Medical University of Graz — Graz
• Universitätsklinikum St. Pölten — Sankt Pölten

Швеция · 1 центр

• Karolinska University Hospital — Huddinge

Идентификаторы

NCT: NCT07200908 · BJT-778-302 · 2024-517167-23-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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