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

Last updated: February 24, 2026
Sponsor: Bluejay Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Hepatitis

Liver Disorders

Treatment

Brelovitug 300 mg

Brelovitug 900 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 300 mg
Phase: 2/3
Study Start date:
March 25, 2025
Estimated Completion Date:
September 30, 2029

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

  • 102 Melbourne

    Melbourne 2158177, Victoria 2145234
    Australia

    Site Not Available

  • 101 Camperdown

    Camperdown 2172563,
    Australia

    Site Not Available

  • 104 Liverpool

    Liverpool 2159851,
    Australia

    Site Not Available

  • Sliven

    Sliven, Silven 8800
    Bulgaria

    Site Not Available

  • 703 Sliven

    Sliven 727079, Silven 8800
    Bulgaria

    Site Not Available

  • Plovdiv

    Plovdiv,
    Bulgaria

    Site Not Available

  • 705 Plovdiv

    Plovdiv 728193,
    Bulgaria

    Site Not Available

  • Bulgaria

    Sofia,
    Bulgaria

    Site Not Available

  • Sofia

    Sofia,
    Bulgaria

    Active - Recruiting

  • 702 Bulgaria

    Sofia 727011,
    Bulgaria

    Site Not Available

  • 706 Sofia

    Sofia 727011,
    Bulgaria

    Site Not Available

  • Stara Zagora

    Stara Zagora,
    Bulgaria

    Site Not Available

  • 704 Stara Zagora

    Stara Zagora 726848,
    Bulgaria

    Site Not Available

  • 231 Toronto

    Toronto 6167865, Ontario 6093943
    Canada

    Site Not Available

  • 235 Montreal

    Montreal 6077243, Quebec 6115047
    Canada

    Site Not Available

  • 233 Calgary

    Calgary 5913490,
    Canada

    Site Not Available

  • 234 Alberta

    Edmonton 5946768, T6G 2G5
    Canada

    Site Not Available

  • Tbilisi

    Tbilisi,
    Georgia

    Site Not Available

  • 181 Tbilisi

    Tbilisi 611717, 0105
    Georgia

    Site Not Available

  • 182 Tbilisi

    Tbilisi 611717,
    Georgia

    Site Not Available

  • 183 Tbilisi

    Tbilisi 611717, 0105
    Georgia

    Site Not Available

  • Israel

    Be'er Sheva,
    Israel

    Site Not Available

  • 211 Israel

    Beersheba 295530,
    Israel

    Site Not Available

  • 212 Haifa

    Haifa 294801,
    Israel

    Site Not Available

  • 901 Chisinau

    Chisinau 618426,
    Moldova

    Site Not Available

  • Chisinau

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • 001 Auckland

    Auckland 2193733,
    New Zealand

    Site Not Available

  • 221 Karachi City

    Karachi 1174872,
    Pakistan

    Site Not Available

  • 291 Belgrade

    Belgrade 792680,
    Serbia

    Site Not Available

  • 191 Istanbul

    Istanbul 745044,
    Turkey (Türkiye)

    Site Not Available

  • Kyiv

    Kyiv, 01001
    Ukraine

    Site Not Available

  • 110 Kyiv

    Kyiv 703448, 01001
    Ukraine

    Site Not Available

  • Garden Grove

    Garden Grove, California 92840
    United States

    Site Not Available

  • Huntington Beach

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Long Beach

    Long Beach, California 90805
    United States

    Site Not Available

  • Walnut Creek

    Walnut Creek, California 94598
    United States

    Site Not Available

  • 247 Garden Grove

    Garden Grove 5351515, California 5332921 92840
    United States

    Site Not Available

  • 242 Huntington Beach

    Huntington Beach 5358705, California 5332921 92647
    United States

    Site Not Available

  • 252 Long Beach

    Long Beach 5367929, California 5332921 90805
    United States

    Site Not Available

  • 244 Los Angeles

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • Miami

    Miami, Florida 33166
    United States

    Site Not Available

  • 250 Miami

    Miami 4164138, Florida 4155751 33166
    United States

    Site Not Available

  • 251, Illinois

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Lowa

    Cities in Iowa, Iowa 52242
    United States

    Active - Recruiting

  • 248 Lowa

    Cities in Iowa, Iowa 4862182 52242
    United States

    Site Not Available

  • 248 Lowa

    Multiple Locations, Iowa 4862182 52242
    United States

    Site Not Available

  • Baltimore

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • 254 Baltimore

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • 241, Massachusetts

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • New York

    New York, New York 10007
    United States

    Site Not Available

  • 245 New York

    New York 5128581, New York 5128638 10007
    United States

    Site Not Available

  • 253 New York

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • 255 New York

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • 256 New York

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • 257 Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • San Antonio

    San Antonio, Texas 78215
    United States

    Site Not Available

  • 249 San Antonio

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

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