Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

PHASE3UnknownINTERVENTIONAL
Enrollment

463

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

February 29, 2016

Conditions
Hepatitis B, Chronic
Interventions
DRUG

PEG-Tα1

3.2mg/ml, once a week, taken subcutaneously

DRUG

Placebo to match PEG-Tα1

1ml, once a week, taken subcutaneously

DRUG

Adefovir

10 mg, once daily, taken orally for 48 weeks

Trial Locations (32)

Unknown

302 Military Hoapital of China, Beijing

Beijing YouAn Hospital, Capital Medical University, Beijing

Southwest Hospital, Chongqing

The First Affiliated Hospital of Chongqing Medical University, Chongqing

The First Hospital of Lanzhou University, Lanzhou

Shenzhen People's Hospital, Shenzhen

Hainan General Hospital, Haikou

The First Hospital of Hebei Medical University, Shijiazhuang

The Third Hospital of Hebei Medical University, Shijiazhuang

People's Hospital of Wuhan University, Wuhan

Zhongshan Hospital of Hubei Province, Wuhan

The Second Xiangya Hospital of Central South University, Changsha

The Third Xiangya Hospital of Central South University, Changsha

The First Affiliated Hospital of South China University, Hengyang

81 Military Hospital of China, Nanjing

Jiangsu Province Hospital, Nanjing

The Second Hospital of Nanjing, Nanjing

The Affiliated Hospital of Xuzhou Medical College, Xuzhou

The First Hospital of Jilin University, Changchun

Yanbian University Hospital, Yanbian

The Sixth People's Hospital of Shenyang, Shenyang

Jinan Infectious Disease Hospital, Jinan

Qilu Hospital of Shandong University, Jinan

The Six People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai

Tangdu Hospital, Xi’an

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

The Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an

Xijing Hospital, Xi’an

West China Hospital Sichuan University, Chengdu

Tianjin Second People's Hospital, Tianjin

XiXi Hospital of Hangzhou, Hangzhou

Taizhou Hospital of Zhejiang Province, Taizhou

All Listed Sponsors
collaborator

Nanjing Medical University

OTHER

lead

Jiangsu Hansoh Pharmaceutical Co., Ltd.

INDUSTRY