Chronic Hepatitis Delta.
Conditions
Brief summary
Part A Endpoints : Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and graded laboratory abnormalities. Serum PK parameters AUClast, AUCinf, Cmax, Tmax, and t1/2 of GS-4321, as applicable. Additional parameters may be evaluated as applicable., Part B Endpoints: Proportion of participants with combined response (defined as undetectable hepatitis delta virus [HDV] RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal alanine aminotransferase [ALT] (ALT < upper limit of normal [ULN]) at Week 24). Incidences of TEAEs, SAEs, and graded laboratory abnormalities
Detailed description
Part A Endpoints: Proportion of participants who develop antidrug antibodies (ADAs) after administration of a single dose of GS-4321 and ADA titer characterization, Part B Endpoints: Serum PK parameters AUCtau, Cmax, Tmax, and Ctrough of GS-4321, as applicable. Additional parameters may be evaluated, as applicable., Part B Endpoints: Proportion of participants with undetectable HDV RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal ALT (ALT < ULN) at Weeks 4, 8, 12, 16, 20, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Change from baseline in HDV RNA at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Proportion of participants with undetectable HDV RNA at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Proportion of participants with undetectable HDV RNA or ≥ 2 log10 decrease in HDV RNA from baseline at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Change in liver stiffness by elastography from baseline at Weeks 24, 48, and 96, Part B Endpoints: Proportion of participants with normal ALT at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Proportion of participants who develop ADAs after administration of multiple doses of GS-4321 and ADA titer characterization, Part B Endpoints: Characterize if emergent variants are associated with reduced susceptibility to GS-4321 in vitro and virologic failure in participants with CHD
Interventions
DRUGGS-4321 PLACEBO
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A Endpoints : Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and graded laboratory abnormalities. Serum PK parameters AUClast, AUCinf, Cmax, Tmax, and t1/2 of GS-4321, as applicable. Additional parameters may be evaluated as applicable., Part B Endpoints: Proportion of participants with combined response (defined as undetectable hepatitis delta virus [HDV] RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal alanine aminotransferase [ALT] (ALT < upper limit of normal [ULN]) at Week 24). Incidences of TEAEs, SAEs, and graded laboratory abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A Endpoints: Proportion of participants who develop antidrug antibodies (ADAs) after administration of a single dose of GS-4321 and ADA titer characterization, Part B Endpoints: Serum PK parameters AUCtau, Cmax, Tmax, and Ctrough of GS-4321, as applicable. Additional parameters may be evaluated, as applicable., Part B Endpoints: Proportion of participants with undetectable HDV RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal ALT (ALT < ULN) at Weeks 4, 8, 12, 16, 20, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Change from baseline in HDV RNA at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Proportion of participants with undetectable HDV RNA at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Proportion of participants with undetectable HDV RNA or ≥ 2 log10 decrease in HDV RNA from baseline at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96, Part B Endpoints: Change in liver stiffness by elastography from b | — |
Outcome results
None listed