A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

Conditions

Chronic Hepatitis D Infection

Brief summary

The proportion of participants who achieve: • Undetectable HDV RNA (< LLOQ, target not detected [TND])

Detailed description

Safety endpoints will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE) • Proportion of participants who permanently discontinue treatment due to an adverse event • Change from baseline of serum total bile salts Comparison with bulevirtide will include data through 24 weeks., The proportion of participants who achieve the following at Weeks 24, 48, 72, and 96 of treatment unless otherwise specified: • Virologic response defined as HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND • HDV RNA < LLOQ • HDV RNA < LLOQ, TND (Weeks 48, 72, and 96), • Normal ALT alone and in combination with: − Virologic response defined as HDV RNA ≥ 2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND − HDV RNA < LLOQ − HDV RNA < LLOQ, TND • Change from baseline of HDV RNA • Change from baseline of ALT Comparison with bulevirtide will include data through 24 weeks, • Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up Weeks 24 and 48

Related papers

No related papers found yet.

Interventions

DRUGBULEVIRTIDE

DRUGBJT-778

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of participants who achieve: • Undetectable HDV RNA (< LLOQ, target not detected [TND])	—

Secondary

Measure	Time frame
Safety endpoints will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE) • Proportion of participants who permanently discontinue treatment due to an adverse event • Change from baseline of serum total bile salts Comparison with bulevirtide will include data through 24 weeks., The proportion of participants who achieve the following at Weeks 24, 48, 72, and 96 of treatment unless otherwise specified: • Virologic response defined as HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND • HDV RNA < LLOQ • HDV RNA < LLOQ, TND (Weeks 48, 72, and 96), • Normal ALT alone and in combination with: − Virologic response defined as HDV RNA ≥ 2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND − HDV RNA < LLOQ − HDV RNA < LLOQ, TND • Change from baseline of HDV RNA • Change from baseline of ALT Comparison with bulevirtide will include data through 24 weeks, • Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up We	—

Measure

Time frame

Safety endpoints will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE) • Proportion of participants who permanently discontinue treatment due to an adverse event • Change from baseline of serum total bile salts Comparison with bulevirtide will include data through 24 weeks., The proportion of participants who achieve the following at Weeks 24, 48, 72, and 96 of treatment unless otherwise specified: • Virologic response defined as HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND • HDV RNA < LLOQ • HDV RNA < LLOQ, TND (Weeks 48, 72, and 96), • Normal ALT alone and in combination with: − Virologic response defined as HDV RNA ≥ 2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND − HDV RNA < LLOQ − HDV RNA < LLOQ, TND • Change from baseline of HDV RNA • Change from baseline of ALT Comparison with bulevirtide will include data through 24 weeks, • Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up We

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Outcome results

None listed