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Clinical Trials in Italy / NCT07200908
Recruiting Phase 3

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 Italy 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
No
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)

FacilityCityRegionStatus
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 Italy

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

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 Italy