A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection

Last updated: July 7, 2025
Sponsor: Bluejay Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Hepatitis

Liver Disorders

Treatment

Brelovitug 900 mg

Brelovitug 300 mg

Delayed Treatment with Brelovitug 300mg

Clinical Study ID

NCT06907290
BJT-778-301
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing and able to provide written informed consent.

  • Chronic HDV infection

  • HDV RNA >500 IU/mL at Screening.

  • Abnormal ALT (>upper limit of normal) at Screening.

  • Willing to take or already taking HBV nucleos(t)ide therapy

Exclusion

Exclusion Criteria:

  • 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 ofphlebotomy

  • Presence of other liver disease(s) (does not include HBV or HDV infection) such asnon-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestaticliver disease, hepatocellular carcinoma.

  • Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).

  • Solid organ or bone marrow transplantation Note: other protocol definedInclusion/Exclusion criteria may apply.

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Brelovitug 900 mg
Phase: 2/3
Study Start date:
March 25, 2025
Estimated Completion Date:
June 30, 2028

Study Description

Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:

  • Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.

  • Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.

  • Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.

Connect with a study center

  • Sliven

    Sliven, Silven 8800
    Bulgaria

    Active - Recruiting

  • Plovdiv

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • Sofia

    Sofia,
    Bulgaria

    Active - Recruiting

  • Stara Zagora

    Stara Zagora,
    Bulgaria

    Active - Recruiting

  • Tbilisi

    Tbilisi, 0105
    Georgia

    Active - Recruiting

  • Chisinau

    Chisinau,
    Moldova, Republic of

    Active - Recruiting

  • Kyiv

    Kyiv, 01001
    Ukraine

    Active - Recruiting

  • Garden Grove

    Garden Grove, California 92840
    United States

    Active - Recruiting

  • Huntington Beach

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Long Beach

    Long Beach, California 90805
    United States

    Active - Recruiting

  • Walnut Creek

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Miami

    Miami, Florida 33166
    United States

    Active - Recruiting

  • Lowa

    Cities in Iowa, Iowa 52242
    United States

    Active - Recruiting

  • San Antonio

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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