A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

NCT02065336 ↗

Phase 2 Terminated 58 enrolled Arrowhead Pharmaceuticals ICON Clinical Research · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.

Timeline

Start: 2014-03
Primary completion: 2017-01
Completion: 2017-01

Publications

Yuen MF, Wong DK, Schluep T, Lai CL, Ferrari C, Locarnini S, Lo RC, Gish RG, Hamilton J, Wooddell CI, Mak LY, Given BD. Long-term serological, virological and histological responses to RNA inhibition by ARC-520 in Chinese chronic hepatitis B patients on entecavir treatment. Gut. 2022 Apr;71(4):789-797. doi: 10.1136/gutjnl-2020-323445. Epub 2021 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARC-520	Unknown	1 mg/kg	Intravenous
Subject	ARC-520	Unknown	2 mg/kg	Intravenous
Subject	ARC-520	Unknown	3 mg/kg	Intravenous
Subject	ARC-520	Unknown	4 mg/kg	Intravenous
Subject	ARC-520	Unknown	5 mg/kg	Intravenous
Subject	ARC-520	Unknown	6 mg/kg	Intravenous
Background	Chlorpheniramine	Unknown	8 mg	Oral
Background	Entecavir	Small molecule	—	—

A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection

Summary

Timeline

Publications

Drugs

Indications