The Clinical Trial of the Anti Hepatitis B Placenta Transfer Factor Injection

Summary

Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.

Conditions

• HBeAg Positive Chronic Hepatitis B

Interventions

DRUG

Anti-HBV placenta transfer factor injection

Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

OTHER

Placebo

Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks

Sponsors & Collaborators

• Shineway Pharmaceutical Co.,Ltd

  lead INDUSTRY

Principal Investigators

• Guiqiang Wang, Doctor · Peking University First Hospital

• Maorong Wang, Doctor · China People's Liberation Army No. Eight One Hospital

• Zheling Wang, Doctor · Qingdao Infectious Diseases Hospital

• Zhiqiang zou, Doctor · Yantai Infectious Diseases Hospital

• Peili Zhao, Doctor · The Third Hospital of Qinhuangdao City

• Dexing Jia, Doctor · Weifang People's Hospital

• Zhenghua Zhao, Doctor · Tai'an Central Hospital

• Feng Gao, Doctor · Linyi People's Hospital

• Sikui Wang, Doctor · Liaocheng People's Hospital

• lingdao Huo, Doctor · The Third People's Hospital of Taiyuan

• Yuping Ma, Doctor · Xi'an Eighth Hospital

• Hongxu Zhang, Doctor · Luohe Central Hospital

• Xu Zhang, Doctor · General Hospital of Ningxia Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-12-31

Completion

2017-12-31