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

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

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.

Conditions2

Locations15 sites

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