Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT07454837

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

Led by Mirum Pharmaceuticals, Inc. · Updated on 2026-05-01

120

Participants Needed

22

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide written informed consent
  • Male or female, 18 years of age or older at Screening
  • Taking or willing to take TDF, TAF, or ETV at baseline and willing to remain on stable treatment throughout the study
  • Currently receiving bulevirtide treatment for chronic hepatitis Delta for at least 6 months at Screening
  • HDV RNA level of 100 IU/mL or higher at Screening
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Medical University of Graz

Graz, Austria, 8010

Actively Recruiting

2

Fakultni Nemocnice Brno (University Hospital Brno)

Brno, Czechia, 62500

Actively Recruiting

3

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

Prague, Czechia, 12000

Actively Recruiting

4

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

Prague, Czechia, 14021

Actively Recruiting

5

CHU de Bordeaux

Bordeaux, France, 33076

Actively Recruiting

6

Hospital Beaujon

Clichy, France, 92110

Actively Recruiting

7

CHU Toulouse Hospital Rangueil, Toulouse

Toulouse, France, 31400

Actively Recruiting

8

University Hospital of Dusseldorf

Düsseldorf, Germany, 40225

Actively Recruiting

9

Goethe University Frankfurt

Frankfurt, Germany, 60323

Actively Recruiting

10

Medizinische Hochschule Hannover

Hanover, Germany, 30625

Actively Recruiting

11

Universitatsmedizin Rostock

Rostock, Germany, 18057

Actively Recruiting

12

Centrul Medical Unirea S.R.L

Iași, Lasi, Romania, 700023

Actively Recruiting

13

Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes

Bucharest, Romania, 030303

Actively Recruiting

14

National Institute Of Infectious Diseases Prof. Dr. Matei Bals

Bucharest, Romania, 21105

Actively Recruiting

15

Spitalul Clinic de Boli Infectioase Constanta

Constanța, Romania, 900709

Actively Recruiting

16

Vall d'Hebron Hospital

Barcelona, Spain, 08035

Actively Recruiting

17

Hospital Clinic I Provincial De Barcelona

Barcelona, Spain, 08036

Actively Recruiting

18

Castle Hill Hospital

Cottingham, Yorkshire, United Kingdom, HU165JQ

Actively Recruiting

19

Barts Health NHS Trust

London, United Kingdom, E12AT

Actively Recruiting

20

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

Actively Recruiting

21

Chelsea and Westminster Hospital

London, United Kingdom, SW109NH

Actively Recruiting

22

Manchester University Nhs Foundation Trust

Manchester, United Kingdom, M13 9WL

Actively Recruiting

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Research Team

C

Clinical Trials Mirum

CONTACT

M

Medinfo Mirum

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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