This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 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 bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Route of administration- Subcutaneous Injection
Route of Administration- Subcutaneous Injection
Medical University of Graz
Graz, Austria
Percentage of participants with a composite endpoint of virologic response and ALT normalization
The composite endpoint is defined as virologic response (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 48
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 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
ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN
Time frame: Up to 96 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fakultni Nemocnice Brno
Brno, Brno, Czechia
RECRUITINGFakultni Nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
RECRUITINGInstitute For Clinical And Experimental Medicine
Prague, Prague, Czechia
RECRUITINGKlin Med s.r.o.
Prague, Prague, Czechia
RECRUITINGGoethe University Frankfurt
Frankfurt, Frankfurt, Germany
RECRUITINGRostock University Medical Center
Rostock, Rostock, Germany
RECRUITINGNational Institute Of Infectious Diseases
Bucharest, Bucharest, Romania
RECRUITINGSpitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Bucharest, Bucharest, Romania
RECRUITINGCentrul Medical Unirea S.R.L
Iași, Lasi, Romania
RECRUITING...and 10 more locations
Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or 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
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
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 Health-Related Quality of Life (HRQoL) as measured by the Chronic Liver Disease Questionnaire-HBV (CLDQ-HBV)
Time frame: Up to 96 Weeks
Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Up to 96 Weeks