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

Phase 2

Recruiting

• Conditions: Chronic Hepatitis D Infection
• Interventions: Drug: Brelovitug 300 mg; Drug: Brelovitug 900 mg; Drug: Delayed Treatment with Brelovitug 300mg

• Registration Number: NCT06907290
• Lead Sponsor: Bluejay Therapeutics, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-25
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brelovitug 300mg	Brelovitug 300 mg	Dose - brelovitug 300 mg Frequency- once weekly
Brelovitug 900mg	Brelovitug 900 mg	Dose - brelovitug 900 mg Frequency- once every 4 weeks
Delayed Treatment with brelovitug 300mg	Delayed Treatment with Brelovitug 300mg	Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly

Primary Outcome Measures

Name	Time	Method
Percentage of participants with a composite endpoint	Week 24	Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS	Weeks 24, 48, 96, and 120, if applicable	Frequency and severity of TEAEs and serious AEs
Percentage of participants that achieve that achieve virologic response and ALT normalization	Weeks 24, 48, 96, and 120, if applicable	Change from baseline in HDV RNA and ALT normalization
Percentage of participants with a composite endpoint by treatment regimen	Weeks 24, 48, 96, and 120, if applicable	Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug
Percentage of participants with HDV associated liver disease progression	Weeks 24, 48, 96, and 120, if applicable	Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs.

Trial Locations

Locations (4)

Garden Grove; 🇺🇸 Garden Grove, California, United States

Huntington Beach; 🇺🇸 Huntington Beach, California, United States

Walnut Creek; 🇺🇸 Walnut Creek, California, United States

Chisinau; 🇲🇩 Chisinau, Moldova, Republic of