Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection

PHASE2TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Hepatitis B
Interventions
DRUG

ARC-520 Injection

IV injection

DRUG

entecavir

All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.

DRUG

tenofovir

All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.

DRUG

antihistamine

All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.

Trial Locations (6)

999077

Queen Mary Hospital, Hong Kong

04103

Eugastro Gmbh, Leipzig

602-739

Pusan National University Hospital, Busan

405-760

Gachon University Gil Medical Center, Incheon

110-744

Seoul National University Hospital, Seoul

120-752

Severance Hospital, Yonsei University College of Medicine, Seoul

Sponsors
All Listed Sponsors
lead

Arrowhead Pharmaceuticals

INDUSTRY