A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
- Conditions
- Chronic Hepatitis D Infection
- Interventions
- Drug: Brelovitug 300 mgDrug: Bulevirtide 2 mg and Brelovitug - 300 mg
- Registration Number
- NCT07200908
- Lead Sponsor
- Bluejay Therapeutics, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 172
- Willing and able to provide written informed consent
- Chronic HDV infection
- HDV RNA >500 IU/mL at Screening
- ALT >ULN at Screening
- Willing to take or already taking HBV neucleos(t)ide therapy.
Key
- 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
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
- Solid organ or bone marrow transplantation
- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
Note - Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brelovitug Brelovitug 300 mg Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks Bulevirtide for 48 weeks followed by brelovitug for 48 weeks Bulevirtide 2 mg and Brelovitug - 300 mg 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.
- Primary Outcome Measures
Name Time Method Percentage of participants with a composite endpoint of virologic response and ALT normalization Week 48 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 \[ULN\])
- Secondary Outcome Measures
Name Time Method Percentage of participants with treatment-emergent adverse events (TEAEs) Up to 96 weeks 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.
Percentage of participants who discontinue treatment due to an adverse event (AE) Up to 96 weeks 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.
Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND Up 96 Weeks Percentage of participants with HDV RNA <LLOQ Up to 96 Weeks Percentage of participants with HDV RNA <LLOQ, TND Up to 96 Weeks Percentage of participants with ALT normalization Up to 96 Weeks ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN
Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND Up to 96 Weeks 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.
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ Up to 96 Weeks The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \<LLOQ.
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND Up to 96 Weeks The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \<LLOQ, TND.
Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) Up to 96 Weeks Change from baseline in APRI (AST-to-platelet ratio index) Up to 96 Weeks Change from baseline in CTP score in participants with cirrhosis Up to 96 Weeks Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis Up to 96 Weeks Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease. Up to 96 Weeks Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).
Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up. 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) 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) Up to 96 Weeks
Trial Locations
- Locations (12)
Institute For Clinical And Experimental Medicine
🇨🇿Prague, Prague, Czechia
Klin Med s.r.o.
🇨🇿Prague, Prague, Czechia
Goethe University Frankfurt
🇩🇪Frankfurt, Frankfurt, Germany
Rostock University Medical Center
🇩🇪Rostock, Rostock, Germany
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
🇷🇴Bucharest, Bucharest, Romania
Centrul Medical Unirea S.R.L
🇷🇴Iași, Lasi, Romania
Hospital Universitario Torrecardenas
🇪🇸Almería, Almeria, Spain
Chelsea and Westminster Hospital NHS Foundation Trust
🇬🇧London, London, United Kingdom
Medical University of Graz
🇦🇹Graz, Austria
Hull University Teaching Hospitals
🇬🇧Cottingham, United Kingdom
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