NCT07298330

Brief 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.

Trial Health

88
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
32mo left

Started Jan 2026

Typical duration for phase_3

Geographic Reach
10 countries

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

December 19, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

January 14, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

December 19, 2025

Last Update Submit

February 26, 2026

Conditions

Chronic Hepatitis D Infection

Keywords

Hepatitis Delta virusHDVHepatitis D infectionHepatitis D virus

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm

    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 \[ULN\])

    Week 24

Secondary Outcomes (15)

  • Percentage of participants with treatment-emergent adverse events (TEAEs)

    Up to 96 weeks

  • Percentage of participants who discontinue treatment due to an adverse event (AE)

    Up to 96 weeks

  • Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

    Up to 96 Weeks

  • Percentage of participants with HDV RNA <LLOQ

    Up to 96 Weeks

  • Percentage of participants with HDV RNA <LLOQ, TND

    Up to 96 Weeks

  • +10 more secondary outcomes

Study Arms (3)

Brelovitug 300 mg

EXPERIMENTAL

Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks

Drug: Brelovitug 300 mg

Brelovitug 900 mg

EXPERIMENTAL

Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks

Drug: Brelovitug 900 mg

Delayed treatment with brelovitug 300 mg

ACTIVE COMPARATOR

Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks

Drug: Delayed Treatment with Brelovitug 300mg

Interventions

Brelovitug 300 mgDRUG

Route of administration- Subcutaneous Injection

Also known as: BJT-778, BTG
Brelovitug 300 mg
Brelovitug 900 mgDRUG

Route of administration- Subcutaneous Injection

Also known as: BJT-778, BTG
Brelovitug 900 mg
Delayed Treatment with Brelovitug 300mgDRUG

Route of administration- Subcutaneous Injection

Also known as: BJT-778, BTG
Delayed treatment with brelovitug 300 mg

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to provide written informed consent
  • Chronic HDV infection
  • HDV RNA \>500 IU/mL at Screening
  • ALT \>ULN at Screening
  • Willing to take or already taking HBV nucleos(t)ide therapy.

You may not qualify if:

  • Pregnant or nursing females
  • Unwilling to comply with contraception requirements during the study
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
  • Solid organ or bone marrow transplantation
  • Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

University of California, Davis

Davis, California, 95616, United States

RECRUITING

Kaiser Permanente Medical Center

Sacramento, California, 95661, United States

RECRUITING

Quest Clinical Research

San Francisco, California, 94115, United States

RECRUITING

Denver Health Medical Center

Denver, Colorado, 80204, United States

RECRUITING

Alliance Clinical, Las Vegas

Las Vegas, Nevada, 89019, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Prime Clinical Research Inc

Mansfield, Texas, 76063, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Erasme Hospital

Brussels, Belgium

RECRUITING

University Hospital Antwerp (UZA)

Edegem, Belgium

RECRUITING

University Hospital Center Sart-Tilman

Liège, Belgium

RECRUITING

Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda

Sofia, 1407, Bulgaria

RECRUITING

Hospital Service LTD

Kutaisi, 4608, Georgia

RECRUITING

Diakori LLC

Tbilisi, 0159, Georgia

RECRUITING

JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, 0159, Georgia

RECRUITING

LTD Academician Vakhtang Bochorishvili Clinic

Tbilisi, 0160, Georgia

RECRUITING

Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases

Budapest, H-1097, Hungary

RECRUITING

Fejer County St. Gyorgy University Teaching Hospital

Székesfehérvár, H-8000, Hungary

RECRUITING

Soroka University Medical Center

Beersheba, 8410101, Israel

RECRUITING

HaEmek Medical Center

Haifa, 3296043, Israel

RECRUITING

Aga Khan University & Hospital

Karachi, Karachi, 74800, Pakistan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807377, Taiwan

RECRUITING

E-Da Hospital

Kaohsiung City, 82445, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life"

Poltava, 36000, Ukraine

RECRUITING

Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council

Rivne, 33018, Ukraine

RECRUITING

Research Institute of Virology of the Republic of Uzbekistan

Tashkent, 100194, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Hepatitis D

Interventions

Treatment Delay

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Time-to-TreatmentPatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Clinical Trials Mirum

CONTACT

+16506674085clinicaltrials@mirumpharma.com

Mirum Pharmaceuticals, Inc., Clinical Trials

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

December 23, 2025

Study Start

January 14, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2029

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)BU(1)BE(3)UZ(1)HU(2)UA(2)GE(4)PA(1)US(8)IL(2)