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Clinical Trials in the UK / NCT07454837
Recruiting Phase 2/3

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

NCT07454837 · tracked via the Priya Life Science UK tracker
Sponsor
Mirum Pharmaceuticals, Inc.
Phase
Phase 2/3
Started
2026-02-26
Last updated
2026-09-10

Condition(s) studied

Chronic Hepatitis D

Investigational drug(s) / intervention(s)

Brelovitug (BJT-778)Bulevirtide

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

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Willing and able to provide written informed consent. 2. Male or female, ≥18 years of age at Screening. 3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study. 4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening. 5. HDV RNA ≥100 IU/mL at Screening. Exclusion Criteria: 1. Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding). 2. Known history of immune-complex disease. 3. Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 4. Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis). 5. History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
Medical University of Graz Graz Austria Recruiting
Medizinische Universitat Innsbruck Innsbruck Austria Recruiting
University Hospital St. Polten- Lilenfeld Lilienfeld Austria Recruiting
Medical University of Vienna Vienna Austria Recruiting
Fakultni Nemocnice Brno (University Hospital Brno) Brno Czechia Recruiting
Klin Med Ltd. (KLIN MED s.r.o.) Prague Czechia Recruiting
Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine) Prague Czechia Recruiting
CHU de Bordeaux Bordeaux France Recruiting
Clermont-Ferrand University Hospital Clermont-Ferrand France Recruiting
Hospital Beaujon Clichy France Recruiting
Centre Hospitalier Intercommunal De Creteil Créteil France Recruiting
Henri Mondor University Hospital (APHP) Créteil France Recruiting
CHU Grenoble Alpes Hopital Nord Michallon Grenoble France Recruiting
CHU Limoges Limoges France Recruiting
Hospital De La Croix Rousse Lyon France Recruiting
Hopital Saint-Eloi Montpellier France Recruiting
Pitie-Salpetriere Hosptial Paris France Recruiting
Chu de Rennes Hopital Pontchaillou Rennes France Recruiting
CHU Toulouse Hospital Rangueil, Toulouse Toulouse France Recruiting
Centre Hospitalier de Versailles Versailles France Recruiting
University Hospital of Dusseldorf Düsseldorf Germany Recruiting
Goethe University Frankfurt Frankfurt Germany Recruiting
ICH Study Center GmbH & Co KG Hamburg Germany Recruiting
Medizinische Hochschule Hannover Hanover Germany Recruiting
Universitatsmedizin Rostock Rostock Germany Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Bergamo Italy Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy Recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan Italy Recruiting
Centrul Medical Unirea S.R.L Iași Lasi Recruiting
National Institute Of Infectious Diseases Prof. Dr. Matei Bals Bucharest Romania Recruiting
Fundeni Clinical Institute Bucharest Romania Recruiting
Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes Bucharest Romania Recruiting
National Institute Of Infectious Diseases Prof. Dr. Matei Bals Bucharest Romania Recruiting
Spitalul Clinic de Boli Infectioase Constanta Constanța Romania Recruiting
Vall d'Hebron Hospital Barcelona Spain Recruiting
Hospital Clinic I Provincial De Barcelona Barcelona Spain Recruiting
Marques De Valdecilla University Hospital Cantoria Spain Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Castle Hill Hospital Cottingham Yorkshire Recruiting
Cardiff and Vale University Health Board Cardiff United Kingdom Recruiting

+ 4 more sites — see the full list on the official registry below.

More Mirum Pharmaceuticals, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07454837 on ClinicalTrials.gov ↗ ← All trials in the UK