Actively Recruiting
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
Eligibility Criteria
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
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
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
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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