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

Last updated: January 9, 2026
Sponsor: Bluejay Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hepatitis

Liver Disorders

Treatment

Brelovitug 300 mg

Bulevirtide 2 mg and Brelovitug - 300 mg

Clinical Study ID

NCT07200908
BJT-778-302
2024-517167-23-00
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Willing and able to provide written informed consent

  2. Chronic HDV infection

  3. HDV RNA >500 IU/mL at Screening

  4. ALT >ULN at Screening

  5. Willing to take or already taking HBV neucleos(t)ide therapy.

Exclusion

Key Exclusion Criteria:

  1. Pregnant or nursing females

  2. Unwilling to comply with contraception requirements during the study

  3. Difficulty with blood collection and/or poor venous access for the purposes ofphlebotomy

  4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).

  5. Solid organ or bone marrow transplantation

  6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholicsteatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease,hepatocellular carcinoma.

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

Study Design

Total Participants: 172
Treatment Group(s): 2
Primary Treatment: Brelovitug 300 mg
Phase: 3
Study Start date:
August 27, 2025
Estimated Completion Date:
September 30, 2029

Study 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.

Connect with a study center

  • Medical University of Graz

    Graz 2778067, 8036
    Austria

    Active - Recruiting

  • Fakultni Nemocnice Brno

    Brno 3078610, Brno 62500
    Czechia

    Active - Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové 3074967, Hradec Králové 500 03
    Czechia

    Active - Recruiting

  • Institute For Clinical And Experimental Medicine

    Prague 3067696, Prague 3067695 140 00
    Czechia

    Active - Recruiting

  • Klin Med s.r.o.

    Prague 3067696, Prague 3067695 2 120 00
    Czechia

    Active - Recruiting

  • Goethe University Frankfurt

    Frankfurt 2925536, Frankfurt 60590
    Germany

    Active - Recruiting

  • Rostock University Medical Center

    Rostock 2844588, Rostock 18057
    Germany

    Active - Recruiting

  • National Institute Of Infectious Diseases

    Bucharest 683506, Bucharest 021105
    Romania

    Active - Recruiting

  • Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes

    Bucharest 683506, Bucharest 030303
    Romania

    Active - Recruiting

  • Centrul Medical Unirea S.R.L

    Iași 675810, Lasi 700023
    Romania

    Active - Recruiting

  • Hospital Universitario Torrecardenas

    Almería 2521886, Almeria 04009
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona 3128760, Barcelona 08035
    Spain

    Active - Recruiting

  • Hôpitaux Universitaires

    Geneva 2660646, Canton of Geneva 2660645 1205
    Switzerland

    Active - Recruiting

  • HOCH Health Ostschweiz

    Sankt Gallen 2658822, St.Gallen 95 9007
    Switzerland

    Active - Recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham 2655603, Birmingham B15 2GW
    United Kingdom

    Active - Recruiting

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London 2643743, London SW10 9NH
    United Kingdom

    Active - Recruiting

  • North Manchester General Hospital

    Manchester 2643123, Manchester M8 5RB
    United Kingdom

    Active - Recruiting

  • Hull University Teaching Hospitals

    Cottingham 2652263, HU16 5JQ
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London 2643743, E12ES
    United Kingdom

    Active - Recruiting

  • King's College Hospital NHS Foundation Trust

    London 2643743, SE5 9RS
    United Kingdom

    Active - Recruiting

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