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

Recruiting now · Phase 2/Phase 3

Conditions studied: Chronic Hepatitis D

In brief

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).

Key facts

Study ID

NCT07454837

Run by

Mirum Pharmaceuticals, Inc.

People needed

120

Starts

2026-02-26

Expected to finish

2029-03-30

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Medical University of Graz — Graz, Austria (enrolling)
• Medizinische Universitat Innsbruck — Innsbruck, Austria (enrolling)
• Fakultni Nemocnice Brno (University Hospital Brno) — Brno, Czechia (enrolling)
• Klin Med Ltd. (KLIN MED s.r.o.) — Prague, Czechia (enrolling)
• Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine) — Prague, Czechia (enrolling)
• CHU de Bordeaux — Bordeaux, France (enrolling)
• Clermont-Ferrand University Hospital — Clermont-Ferrand, France (enrolling)
• Hospital Beaujon — Clichy, France (enrolling)
• Henri Mondor University Hospital (APHP) — Créteil, France (enrolling)
• CHU Grenoble Alpes Hopital Nord Michallon — Grenoble, France (enrolling)
• CHU Limoges — Limoges, France (enrolling)
• Hospital De La Croix Rousse — Lyon, France (enrolling)
• Hopital Saint-Eloi — Montpellier, France (enrolling)
• Pitie-Salpetriere Hosptial — Paris, France (enrolling)
• CHU Toulouse Hospital Rangueil, Toulouse — Toulouse, France (enrolling)
• University Hospital of Dusseldorf — Düsseldorf, Germany (enrolling)
• Goethe University Frankfurt — Frankfurt, Germany (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
• Universitatsmedizin Rostock — Rostock, Germany (enrolling)
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
• Centrul Medical Unirea S.R.L — Iași, Lasi, Romania (enrolling)
• National Institute Of Infectious Diseases Prof. Dr. Matei Bals — Bucharest, Romania (enrolling)
• Fundeni Clinical Institute — Bucharest, Romania (enrolling)
• Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes — Bucharest, Romania (enrolling)
• National Institute Of Infectious Diseases Prof. Dr. Matei Bals — Bucharest, Romania (enrolling)

Full record on ClinicalTrials.gov

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