Chronic Hepatitis Delta Infection
Conditions
Brief summary
The proportion of participants who achieve a composite endpoint of virologic response and ALT normalization. • Virologic response is defined as HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (< lower limit of quantification [LLOQ], target not detected [TND]),• ALT normalization is defined as a decrease in ALT from Baseline to ≤UNL. • The primary efficacy analysis will be tested according to the hierarchical testing.
Detailed description
The proportion of participants who achieve a composite endpoint of virologic response and ALT normalization. • Virologic response is defined as HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (< lower limit of quantification [LLOQ], target not detected [TND]),• ALT normalization is defined as a decrease in ALT from Baseline to ≤UNL. • The primary efficacy analysis will be tested according to the hierarchical testing., Safety endpoint will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE). • Proportion of participants who permanently discontinue treatment due to an adverse event., The proportion of participants who achieve the following during treatment: • Virologic response defined as ≥2 log10 IU/mL decline from baseline or undetectable HDV RNA • HDV RNA , The proportion of participants who achieve a composite endpoint at Weeks 24, 48, and 96., • Change from Baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) at Weeks 24, 48, 96, 120 (Arm 3). • Change from Baseline in APRI at Weeks 24, 48, 96, 120 (Arm 3). • Change from Baseline in CTP score at Weeks 24, 48, 96, and 120 (Arm 3) in cirrhotic participants. • Change from Baseline in MELD score at Weeks 24, 48, 96, 120 (Arm 3) in cirrhotic participants., • Proportion of participants with clinical disease progression from Baseline in HDV-associated liver disease at Weeks 24, 48, 96, 120 (Arm 3). Progression will be determined by the IDMC.
Interventions
DRUGBJT-778
Sponsors
Bluejay Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants who achieve a composite endpoint of virologic response and ALT normalization. • Virologic response is defined as HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (< lower limit of quantification [LLOQ], target not detected [TND]),• ALT normalization is defined as a decrease in ALT from Baseline to ≤UNL. • The primary efficacy analysis will be tested according to the hierarchical testing. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants who achieve a composite endpoint of virologic response and ALT normalization. • Virologic response is defined as HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (< lower limit of quantification [LLOQ], target not detected [TND]),• ALT normalization is defined as a decrease in ALT from Baseline to ≤UNL. • The primary efficacy analysis will be tested according to the hierarchical testing., Safety endpoint will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE). • Proportion of participants who permanently discontinue treatment due to an adverse event., The proportion of participants who achieve the following during treatment: • Virologic response defined as ≥2 log10 IU/mL decline from baseline or undetectable HDV RNA • HDV RNA , The proportion of participants who achieve a composite endpoint at Weeks 24, 48, and 96., • Change from Baseline in liver stiffness as determined by transient elastography (e.g., | — |
Countries
Bulgaria
Outcome results
None listed