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)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Germany
University Hospital of Dusseldorf
RECRUITING
Düsseldorf
Medizinische Hochschule Hannover
RECRUITING
Hanover
Romania
Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes
RECRUITING
Bucharest
National Institute Of Infectious Diseases Prof. Dr. Matei Bals
RECRUITING
Bucharest
Centrul Medical Unirea S.R.L
RECRUITING
Iași
United Kingdom
Castle Hill Hospital
RECRUITING
Cottingham
Barts Health NHS Trust
RECRUITING
London
Chelsea and Westminster Hospital
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
Contact Information
Primary
Clinical Trials Mirum
clinicaltrials@mirumpharma.com
+16506674085
Backup
Medinfo Mirum
medinfo@mirumpharma.com
Time Frame
Start Date: 2026-02-26
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 120
Treatments
Experimental: Immediate Switch to Brelovitug
Participants will switch to brelovitug 300 mg once weekly for 96 weeks.
Experimental: Delayed Switch from Bulevirtide to Brelovitug
Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.
Related Therapeutic Areas
Sponsors
Leads: Mirum Pharmaceuticals, Inc.