Active — Not RecruitingPhase 2/3

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

United States150 participantsStarted 2025-03-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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 of phlebotomy * Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. * Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). * Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.

What they're measuring

Percentage of participants with a composite endpoint

Timeframe: Week 24

Trial details

NCT IDNCT06907290

SponsorMirum Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-05