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Recruiting NCT07200908

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

Phase III Interventional Chronic Hepatitis D Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg.
Who it may be relevant to
Registry conditions: Chronic Hepatitis D Infection. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Czechia, France, Germany, Italy +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Percentage of participants with a composite endpoint of virologic response and ALT normalization [Time frame: Week 48]
Secondary outcome measures (12)
  • Percentage of participants with treatment-emergent adverse events (TEAEs) [Time frame: Up to 96 weeks]
  • Percentage of participants who discontinue treatment due to an adverse event (AE) [Time frame: Up to 96 weeks]
  • Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND [Time frame: Up 96 Weeks]
  • Percentage of participants with HDV RNA <LLOQ [Time frame: Up to 96 Weeks]
  • Percentage of participants with HDV RNA <LLOQ, TND [Time frame: Up to 96 Weeks]
  • Percentage of participants with ALT normalization [Time frame: 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 [Time frame: Up to 96 Weeks]
  • Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ [Time frame: Up to 96 Weeks]
  • Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND [Time frame: Up to 96 Weeks]
  • Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) [Time frame: Up to 96 Weeks]
  • Change from baseline in APRI (AST-to-platelet ratio index) [Time frame: Up to 96 Weeks]
  • Change from baseline in CTP score in participants with cirrhosis [Time frame: Up to 96 Weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 12 centers
  • 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
  • … and 4 more centers
Spain · 7 centers
  • 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
United Kingdom · 6 centers
  • 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
Czechia · 5 centers
  • 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
Romania · 5 centers
  • 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
Germany · 4 centers
  • Goethe University Frankfurt — Frankfurt
  • Rostock University Medical Center — Rostock
  • Universitätsklinikum Düsseldorf — Düsseldorf
  • Medizinische Hochschule Hannover — Hanover
Italy · 3 centers
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico — Milan
  • AOU Pisana - Cisanello — Pisa
  • National Institute of Infectious Diseases Lazzaro Spallanzani — Roma
Switzerland · 3 centers
  • Hôpitaux Universitaires — Geneva
  • HOCH Health Ostschweiz — Sankt Gallen
  • Universitätsspital Zürich — Zurich
Austria · 2 centers
  • Medical University of Graz — Graz
  • Universitätsklinikum St. Pölten — Sankt Pölten
Sweden · 1 center
  • Karolinska University Hospital — Huddinge

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗