Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

NCT07298330 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 80 participants
Start Date 2026-01-14
Est. Completion 2029-01
Phase Phase 3

Sponsor

Mirum Pharmaceuticals

14 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07298330

The ClinicalTrials.gov registry entry for NCT07298330 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mirum Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07298330 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07298330?

This trial is sponsored by Mirum Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial