This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.
The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 to one of the following treatment arms: Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks. Arm 2: Participants will receive brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks. Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Route of administration- Subcutaneous Injection
Route of administration- Subcutaneous Injection
Route of administration- Subcutaneous Injection
University of California, Davis
Davis, California, United States
RECRUITINGQuest Clinical Research
San Francisco, California, United States
RECRUITINGPercentage of participants with a composite endpoint of virologic response and ALT normalization at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (\< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])
Time frame: Week 24
Percentage of participants with treatment-emergent adverse events (TEAEs)
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.
Time frame: Up to 96 weeks
Percentage of participants who discontinue treatment due to an adverse event (AE)
An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.
Time frame: Up to 96 weeks
Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND
Time frame: Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ
Time frame: Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization
Bluejay Therapeutics Study Director
CONTACT
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Alliance Clinical, Las Vegas
Las Vegas, Nevada, United States
RECRUITINGPrime Clinical Research Inc
Mansfield, Texas, United States
RECRUITINGHospital Service LTD
Kutaisi, Georgia
RECRUITINGDiakori LLC
Tbilisi, Georgia
RECRUITINGJSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, Georgia
RECRUITINGLTD Academician Vakhtang Bochorishvili Clinic
Tbilisi, Georgia
RECRUITINGSoroka University Medical Center
Beersheba, Israel
RECRUITINGAga Khan University & Hospital
Karachi, Karachi, Pakistan
RECRUITINGALT normalization is defined as a decrease in ALT from baseline to ≤ ULN
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or <LLOQ, TND
The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND.
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ
The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \<LLOQ
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND
The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \<LLOQ, TND.
Time frame: Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.
Time frame: Post-Treatment Weeks 24 and 48
Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)
Time frame: Up to 96 Weeks
Change from baseline in APRI (AST-to-platelet ratio index)
Time frame: Up to 96 Weeks
Change from baseline in CTP score in participants with cirrhosis
Time frame: Up to 96 Weeks
Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis
Time frame: Up to 96 Weeks
Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.
Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).
Time frame: Up to 96 Weeks