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NCT07298330 · ClinicalTrials.gov registry record · Phase 3
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
A Phase 3 study of Chronic Hepatitis D Infection, sponsored by Mirum Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT07298330: Recruiting Phase 3 study of Chronic Hepatitis D Infection, sponsored by Mirum Pharmaceuticals.
NCT07298330 is a Phase 3 study of Chronic Hepatitis D Infection that is actively recruiting participants, run by Mirum Pharmaceuticals. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07298330, a Phase 3 study of Chronic Hepatitis D Infection, is actively recruiting participants, sponsored by Mirum Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.
Primary Outcome
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or 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 \[ULN\])
Conditions Studied
Interventions
- DRUG Brelovitug 300 mg
- DRUG Brelovitug 900 mg
- DRUG Delayed Treatment with Brelovitug 300mg
Study Locations (20)
Other
- Erasme Hospital - Brussels
- University Hospital Antwerp (UZA) - Edegem
- University Hospital Center Sart-Tilman - Liège
- Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda - Sofia
- Hospital Service LTD - Kutaisi
- Diakori LLC - Tbilisi
- JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center - Tbilisi
- LTD Academician Vakhtang Bochorishvili Clinic - Tbilisi
- Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases - Budapest
- Fejer County St. Gyorgy University Teaching Hospital - Székesfehérvár
- Soroka University Medical Center - Beersheba
- HaEmek Medical Center - Haifa
California
- University of California, Davis - Davis
- Kaiser Permanente Medical Center - Sacramento
- Quest Clinical Research - San Francisco
Colorado
- Denver Health Medical Center - Denver
Nevada
- Alliance Clinical, Las Vegas - Las Vegas
Ohio
- Cleveland Clinic - Cleveland
Texas
- Prime Clinical Research Inc - Mansfield
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-01-14 |
| Est. Completion | 2029-01 |
| Phase | Phase 3 |
What NCT07298330 shows while recruiting
NCT07298330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Chronic Hepatitis D Infection appearing as the primary indexed condition, and to 3 interventions - of which Brelovitug 300 mg is the first listed.
NCT07298330 names 20 study sites across 7 states, led by Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT07298330 about?
NCT07298330 is a clinical study titled "A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)". This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compar...
What is the current status of trial NCT07298330?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2026-01-14. Estimated completion is 2029-01.
What conditions does trial NCT07298330 study?
This clinical trial studies the following conditions: Chronic Hepatitis D Infection.
What interventions are being tested in trial NCT07298330?
The interventions under investigation include: Brelovitug 300 mg (DRUG), Brelovitug 900 mg (DRUG), Delayed Treatment with Brelovitug 300mg (DRUG).
Who is sponsoring clinical trial NCT07298330?
This trial is sponsored by Mirum Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07298330 being conducted?
This trial has 20 study locations across California, Colorado, Nevada, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis D Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07298330's enrollment target sits among peer trials
80 1756th of 2000 higher than 233 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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