Conditions: Chronic Hepatitis B
Keywords: Hepatitis B Virus Chronic Hepatitis B HBV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
Participants with chronic HBV infection will receive multiple doses of ARC-520 in combination with entecavir or tenofovir and be evaluated for safety and efficacy.

Detailed description:

Arms:
arm 1: Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug. arm 2: Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo.

Interventions: intervention 1: ARC-520 intervention 2: Placebo intervention 3: Entecavir intervention 4: Tenofovir intervention 5: diphenhydramine
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: 0.5 or 1.0 mg/day orally intervention 4: 300 mg/day orally intervention 5: 50 mg orally as pretreatment antihistamine

Protocol document: