This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).
This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.
Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])
The proportion of participants with undetectable HDV RNA (\<LLOQ, TND) at Week 24
Time frame: Week 24
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods.
Time frame: Up to Week 96
Proportion of participants who permanently discontinue treatment due to an adverse event
Proportion of participants who permanently discontinue study treatment because of an adverse event.
Time frame: Up to Week 96
Change from baseline in serum total bile salts
Mean change from baseline in serum total bile salt levels.
Time frame: Up to Week 96
Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)
Proportion of participants with virologic response at Weeks 24, 48, 72, and 96.
Time frame: Up to Week 96
Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.
Time frame: Up to Week 96
Proportion of participants achieving HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.
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Medical University of Graz
Graz, Austria
RECRUITINGMedizinische Universitat Innsbruck
Innsbruck, Austria
RECRUITINGUniversity Hospital St. Polten- Lilenfeld
Lilienfeld, Austria
RECRUITINGMedical University of Vienna
Vienna, Austria
RECRUITINGFakultni Nemocnice Brno (University Hospital Brno)
Brno, Czechia
RECRUITINGKlin Med Ltd. (KLIN MED s.r.o.)
Prague, Czechia
RECRUITINGInstitut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)
Prague, Czechia
RECRUITINGCHU de Bordeaux
Bordeaux, France
RECRUITINGClermont-Ferrand University Hospital
Clermont-Ferrand, France
RECRUITINGHospital Beaujon
Clichy, France
RECRUITING...and 34 more locations
Time frame: Up to Week 96
Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)
Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT with HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96
Time frame: Up to Week 96
Change from baseline in HDV RNA
Change from baseline in HDV RNA levels over time during treatment.
Time frame: Up to Week 96
Change from baseline in ALT levels
Change from baseline ALT levels over time during treatment.
Time frame: Up to Week 96
Change from baseline in liver stiffness
Change from baseline in liver stiffness as determined by transient elastography at weeks 24, 48 and 96
Time frame: Up to Week 96
Change from baseline in APRI
Change from baseline in APRI at weeks 24, 48, and 96
Time frame: Up to Week 96
Change in baseline in CTP score
Change from baseline in CTP score at Weeks 24, 48, and 96 in participants with cirrhosis
Time frame: Up to Week 96
Change from baseline in MELD score
Change from baseline in MELD score at Weeks 24, 48, and 96 in participants with cirrhosis
Time frame: Up to Week 96
Proportion of participants with clinical disease progression from baseline
Proportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96.
Time frame: Up to Week 96
Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up
Time frame: Up to Week 48