Switching from bulevirtide to brelovitug for chronic hepatitis D treatment
A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)
This trial tests whether switching people with chronic hepatitis D who are already taking bulevirtide to brelovitug keeps their infection under control and is safe.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mirum Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 22 sites (Graz and 21 other locations) |
| Trial ID | NCT07454837 on ClinicalTrials.gov |
What this trial studies
This Phase 2b/3 randomized, open-label, multicenter trial enrolls adults with chronic hepatitis D who have been on bulevirtide for at least six months and have detectable HDV RNA. Eligible participants must remain on a stable HBV antiviral (TDF, TAF, or ETV) and have HDV RNA ≥100 IU/mL at screening. Participants are randomized to switch to brelovitug (BJT-778) or continue current therapy, with regular monitoring of HDV RNA, liver function, and safety events. Key exclusions include decompensated liver disease, prior hepatocellular carcinoma, active HCV or HIV co-infection, immune-complex disease, and other significant liver disorders.
Who should consider this trial
Good fit: Adults (≥18) with chronic hepatitis D currently treated with bulevirtide for ≥6 months, with HDV RNA ≥100 IU/mL and on stable TDF/TAF/ETV therapy, without decompensated liver disease or active HCV/HIV, are ideal candidates.
Not a fit: People with decompensated cirrhosis, a history or evidence of hepatocellular carcinoma, active HCV or HIV co-infection, immune-complex disease, or other significant liver diseases are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, switching to brelovitug could offer an effective alternative that maintains or improves viral control with an acceptable safety profile.
How similar studies have performed: Prior studies have shown bulevirtide can suppress HDV, but switching to brelovitug is a newer approach with limited published data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Graz and 21 other locations
- Medical University of Graz — Graz, 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)
- Hospital Beaujon — Clichy, France (Recruiting)
- CHU Toulouse Hospital Rangueil, Toulouse — Toulouse, France (Recruiting)
- University Hospital of Dusseldorf — Düsseldorf, Germany (Recruiting)
- Goethe University Frankfurt — Frankfurt, Germany (Recruiting)
- Medizinische Hochschule Hannover — Hanover, Germany (Recruiting)
- Universitatsmedizin Rostock — Rostock, Germany (Recruiting)
- Centrul Medical Unirea S.R.L — Iași, Lasi, 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)
- Castle Hill Hospital — Cottingham, Yorkshire, United Kingdom (Recruiting)
- Barts Health NHS Trust — London, United Kingdom (Recruiting)
- King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Chelsea and Westminster Hospital — London, United Kingdom (Recruiting)
- Manchester University Nhs Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Mirum
- Email: clinicaltrials@mirumpharma.com
- Phone: +16506674085
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.