A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection

PHASE2TerminatedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Hepatitis B
Interventions
DRUG

ARC-520

OTHER

Placebo

DRUG

entecavir

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.

DRUG

tenofovir

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

Trial Locations (16)

4103

Universitaetsklinikum Leipzig, Leipzig

20099

Asklepios Klinik St. Georg - Chirurgisch-Traumatologisches Zentrum, Hamburg

30625

Medizinische Hochschule Hannover, Hanover

60590

Klinikum der Johann Wolfgang Goethe Universitaet, Frankfurt

72076

University Hospital of Tuebingen, Tübingen

81377

Klinikum Der Ludwig-Maximilian-Universitaet Muenchen, München

89081

Universitaetsklinikum Ulm, Klinik fur Innere Medizin I, Ulm

97080

Universitaetsklinikum Wuerzburg, Medizinische Klinik Und Poliklinik II, Würzburg

999077

Queen Mary Hospital, Hong Kong

Unknown

Prince of Wales 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

626-770

Pusan National University Yangsan Hospital, Yangsan-si Gyeongnam

Sponsors
All Listed Sponsors
lead

Arrowhead Pharmaceuticals

INDUSTRY