A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

NCT07200908 · tracked via the Priya Life Science Germany tracker

Sponsor

Mirum Pharmaceuticals, Inc

Phase

Phase 3

Started

2025-08-27

Last updated

2026-08-25

Condition(s) studied

Chronic Hepatitis D Infection

Investigational drug(s) / intervention(s)

Brelovitug 300 mg →Bulevirtide 2 mg and Brelovitug - 300 mg

Brelovitug 300 mg: Route of administration- Subcutaneous Injection

Bulevirtide 2 mg and Brelovitug - 300 mg: Route of Administration- Subcutaneous Injection

Study summary

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV neucleos(t)ide therapy. Key Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

Percentage of participants with a composite endpoint of virologic response and ALT normalization — Week 48
The composite endpoint is defined as virologic response (undetectable HDV RNA, \< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])

Trial sites (53)

Facility	City	Region	Status
Medical University of Graz	Graz	Austria	Recruiting
Universitätsklinikum St. Pölten	Sankt Pölten	Austria	Recruiting
Fakultni Nemocnice Brno	Brno	Brno	Recruiting
Fakultni Nemocnice Hradec Kralove	Hradec Králové	Hradec Králové	Recruiting
Krajská nemocnice Liberec, a.s.	Liberec	Liberec	Recruiting
Institute For Clinical And Experimental Medicine	Prague	Prague	Recruiting
Klin Med s.r.o.	Prague	Prague	Recruiting
Hôpital Estaing	Clermont-Ferrand	France	Recruiting
Hôpital Beaujon	Clichy	France	Recruiting
University Hospital Henri Mondor - APHP	Créteil	France	Recruiting
CHU Grenoble Alpes Hopital Nord Michallon	La Tronche	France	Recruiting
Centre Hospitalier de Versailles _ Hopital Andre Magnot	Le Chesnay	France	Recruiting
Lille Regional University Hospital Centre	Lille	France	Recruiting
University Hospital Limoges	Limoges	France	Recruiting
Hôpital de la Croix-Rousse	Lyon	France	Recruiting
Hôpital Pitié Salpêtrière	Paris	France	Recruiting
Hopital Cochin	Paris	France	Recruiting
CHU de Bordeaux - Hopital Haut-Leveque	Pessac	France	Recruiting
Centre Hospitalier Universitaire De Rennes	Rennes	France	Recruiting
Hôpital Rangueil	Toulouse	France	Recruiting
Goethe University Frankfurt	Frankfurt	Frankfurt	Recruiting
Rostock University Medical Center	Rostock	Rostock	Recruiting
Universitätsklinikum Düsseldorf	Düsseldorf	Germany	Recruiting
Medizinische Hochschule Hannover	Hanover	Germany	Recruiting
ASST Papa Giovanni XXIII	Bergamo	Italy	Recruiting
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy	Recruiting
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy	Recruiting
AOU Pisana - Cisanello	Pisa	Italy	Recruiting
National Institute of Infectious Diseases Lazzaro Spallanzani	Roma	Italy	Recruiting
National Institute Of Infectious Diseases	Bucharest	Bucharest	Recruiting
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes	Bucharest	Bucharest	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
Spitalul Clinic de Boli Infectioase Constanta	Constanța	Romania	Recruiting
Hospital Universitario Torrecardenas	Almería	Almeria	Recruiting
Hospital Universitari Vall D Hebron	Barcelona	Barcelona	Recruiting
Hospital Clinic Provincial De Barcelona	Barcelona	Spain	Recruiting
Hospital Universitario Ramón y Cajal	Madrid	Spain	Recruiting
Hospital Universitario Virgen de la Victoria	Málaga	Spain	Recruiting

+ 13 more sites — see the full list on the official registry below.

More Mirum Pharmaceuticals, Inc. trials in Germany

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

Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) Active, not recruiting

Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU) Recruiting

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC) Active, not recruiting

A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis Active, not recruiting

Other trials for the same condition

A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection Starting soon

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 NCT07200908 on ClinicalTrials.gov ↗ ← All trials in Germany