NCT07454837

Brief Summary

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).

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
33mo left

Started Feb 2026

Typical duration for phase_2

Geographic Reach
8 countries

35 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Mar 2029

Study Start

First participant enrolled

February 26, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

March 2, 2026

Last Update Submit

June 25, 2026

Conditions

Chronic Hepatitis D

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])

    The proportion of participants with undetectable HDV RNA (\<LLOQ, TND) at Week 24

    Week 24

Secondary Outcomes (18)

  • Incidence and severity of treatment-emergent adverse events (TEAEs)

    Up to Week 96

  • Proportion of participants who permanently discontinue treatment due to an adverse event

    Up to Week 96

  • Change from baseline in serum total bile salts

    Up to Week 96

  • Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)

    Up to Week 96

  • Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.

    Up to Week 96

  • +13 more secondary outcomes

Study Arms (2)

Immediate Switch to Brelovitug

EXPERIMENTAL

Participants will switch to brelovitug 300 mg once weekly for 96 weeks.

Drug: Brelovitug (BJT-778)

Delayed Switch from Bulevirtide to Brelovitug

EXPERIMENTAL

Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.

Drug: Bulevirtide

Interventions

Brelovitug (BJT-778)DRUG

Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.

Also known as: BJT-778
Immediate Switch to Brelovitug
BulevirtideDRUG

Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.

Also known as: BJT-778, Hepcludex
Delayed Switch from Bulevirtide to Brelovitug

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

Medizinische Universitat Innsbruck

Innsbruck, A-6020, Austria

RECRUITING

Fakultni Nemocnice Brno (University Hospital Brno)

Brno, 62500, Czechia

RECRUITING

Klin Med Ltd. (KLIN MED s.r.o.)

Prague, 12000, Czechia

RECRUITING

Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)

Prague, 14021, Czechia

RECRUITING

CHU de Bordeaux

Bordeaux, 33076, France

RECRUITING

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63100, France

RECRUITING

Hospital Beaujon

Clichy, 92110, France

RECRUITING

Henri Mondor University Hospital (APHP)

Créteil, 94000, France

RECRUITING

CHU Grenoble Alpes Hopital Nord Michallon

Grenoble, 38700, France

RECRUITING

CHU Limoges

Limoges, 87000, France

RECRUITING

Hospital De La Croix Rousse

Lyon, 69004, France

RECRUITING

Hopital Saint-Eloi

Montpellier, 34090, France

RECRUITING

Pitie-Salpetriere Hosptial

Paris, 75013, France

RECRUITING

CHU Toulouse Hospital Rangueil, Toulouse

Toulouse, 31400, France

RECRUITING

University Hospital of Dusseldorf

Düsseldorf, 40225, Germany

RECRUITING

Goethe University Frankfurt

Frankfurt, 60323, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitatsmedizin Rostock

Rostock, 18057, Germany

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

Centrul Medical Unirea S.R.L

Iași, Lasi, 700023, Romania

RECRUITING

National Institute Of Infectious Diseases Prof. Dr. Matei Bals

Bucharest, 021105, Romania

RECRUITING

Fundeni Clinical Institute

Bucharest, 022328, Romania

RECRUITING

Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes

Bucharest, 030303, Romania

RECRUITING

National Institute Of Infectious Diseases Prof. Dr. Matei Bals

Bucharest, 21105, Romania

RECRUITING

Spitalul Clinic de Boli Infectioase Constanta

Constanța, 900709, Romania

RECRUITING

Vall d'Hebron Hospital

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic I Provincial De Barcelona

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Castle Hill Hospital

Cottingham, Yorkshire, HU165JQ, United Kingdom

RECRUITING

Cardiff and Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E12AT, United Kingdom

RECRUITING

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Chelsea and Westminster Hospital

London, SW109NH, United Kingdom

RECRUITING

Manchester University Nhs Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hepatitis D, Chronic

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

Hepatitis DHepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Trials Mirum

CONTACT

+16506674085clinicaltrials@mirumpharma.com

Medinfo Mirum

CONTACT

medinfo@mirumpharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

March 30, 2029

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)CZ(3)DE(4)AU(2)RO(6)GB(6)FR(10)IT(1)