79
Participants
Start Date
December 31, 2015
Primary Completion Date
December 31, 2016
Study Completion Date
December 31, 2016
ARC-520
ARC-520 will be administered intravenously concomitantly with 0.9% normal saline using an infusion rate of 0.4 mL/min (24 mL/hour) for study treatment and 200 mL/hr for saline.
entecavir
0.5 mg once daily; oral
pegylated interferon alpha 2a
180 mcg; subcutaneous injection once weekly
tenofovir disoproxil
300 mg once daily; oral
antihistamine
All participants will be pre-treated with an oral antihistamine selected by the investigator from the list of approved antihistamines that is available in that country. Acceptable antihistamines are: diphenhydramine 50 mg p.o., chlorpheniramine 8 mg p.o., hydroxyzine 50 mg p.o., or cetirizine 10 mg p.o.
Changhua Christian Hospital, Changhua
National Taiwan University Hospital, Yun-Lin Branch, Douliu
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City
Auckland Clinical Studies, Auckland
UMHAT St. Ivan Rilski EAD, Clinic of Gastroenterology, Sofia
Diagnostic and Consultative Center - Focus 5 - Outpatient Medical Center, EOOD, Sofia
St. Vincent's Hospital Sydney, Darlinghurst
Middlemore Clinical Trials, Middlemore Hospital, Papatoetoe
Royal Prince Alfred Hospital, Camperdown
Concord Repatriation General Hospital, Gastroenterology & Liver Services, Concord
Westmead Hospital, Westmead
Royal Melbourne Hospital, Parkville
St. Vincent's Hospital Melbourne, Fitzroy
Seoul National University Hospital, Seoul
Monash Health Clayton Campus, Clayton
Royal Adelaide Hospital, Adelaide
MHAT St. Pantaleimon OOD, Department of Gastroenterology, Pleven
Linear Clinical Research Ltd., Nedlands
Gangnam Severance Hospital, Yonsei University Health System, Seoul
Diagnostic and Consultative Center Mladost-M Varna, Varna
King Chulalongkorn Memorial Hospital, Bangkok
Hospital of Tropical Diseases, Bangkok
Phramongkutklao Hospital, Division of Digestive and Liver Disease, Bangkok
Thammasat University Hospital, Gastroenterology Unit, Pathum Thani
Khon Kaen University, Khon Kaen
Kyungpook National University Hospital, Daegu
Pusan National University Hospital, Busan
Maharaj Nakhon Chiang Mai Hospital, Gastroenterology Division, Chiang Mai
Queen Mary Hospital, Department of Medicine, Hong Kong
Dunedin Hospital, Gastroenterology Research Unit, Dunedin
Inje University Busan Paik Hospital, Busan
Severance Hospital, Yonsei University Health System, Seoul
IMSP Spitalul Clinic de Boli Infectioase, Toma Ciorba, Chisinau
Lead Sponsor
Arrowhead Pharmaceuticals
INDUSTRY