Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

Summary

There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients.

In recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB.

The purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.

Conditions

• Hepatitis B, Chronic

Interventions

DRUG

Peginterferon Alfa-2B

Different usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor.

DRUG

Nucleoside Analogs

Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University

  lead OTHER

Principal Investigators

• Zhiliang Gao, Doctor · Third Affiliated Hospital, Sun Yat-Sen University

• Guizhou Zou · The Second Hospital of Anhui Medical University

• Jiabin Li · The First Affiliated Hospital of Anhui Medical University

• Zhende Lin · Anxi County Hospital

• Guoxin Hu · SHENZHEN HOSPITAL of PEKING UNIVERSITY

• Youping Lin · Dongguan Binhai Bay Central Hospital

• Sichun Yin · Dongguan Ninth People's Hospital

• Songmei He · Dongguan People's Hospital

• Zengjia Xu · Dongyuan People's Hospital

• Hui Shen · DuShanZi People's Hospital

• Haifei Luo · First People's Hospital of Foshan

• Wenhua Zhang · Gansu Wuwei Tumor Hospital

• Maosheng Wu · Guangdong Second Provincial People's Hospital

• Dong Wei · Guangzhou Second traditional Chinese Medicine hospital

• Wenli Chen · Guangdong Provincial People's Hospital

• Bihua Gao · Beihai People's hospital

• Guifang Tang · Nanxishan Hospital of Giang xi zhuang Autonomous Region

• Huaiyu Song · THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTCNOMOUS REGION

• Zhuxiang Zhao · The First Municipal Hospital of Guangzhou

• Xihua Fu · Guangzhou Panyu Central Hospital

• Runqi Luo · Second Affiliated Hospital of Guangzhou Medical University

• Shi Ouyang · Fifth Affiliated Hospital of Guangzhou Medical University

• Chunlan Zhang · GUANGZHOU EIGHTH PEOPLE'S HOSPITAL GUANGZHOU MEDICAL UNIVERSITY

• Riying Lv · Guigang city People's Hospital

• Bigang Xiong · GuiYang Public Health Clinlcal Center

• Hong Peng · the People's Hospital of Guizhou

• Sufen Zhou · The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

• Quan Zhang · The Affiliated Hospital Of Guizhou Medical University

• YongChao Xian · The Third People's Hospital of Guilin

• Ganwen Li · The Third Affiliated Hospital of Sun Yat-Sen Unlversity Yuedong hospital

• Jinyu Xia · The Fifth Affiliated Hospital, Sun Yat-sen University

• Bihui Zhong · The First Afiliated Hospital Sun Yat-sen University

• Minhui Xiao · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Wenjun Gao · Zhongshan Sencond People's Hospital

• Gang Li · The fourth people's Hospital of Zibo

• Yangwen Luo · Zunyi Medical College

• Jie Chen · The Second People's Hospital OF YULIN

• Xiaochao Qin · Red Cross Hospital of Yulin City

• Wuhai Qin · teaditional chinese medicine hospital of YULIN

• Hongshun Fan · Yuebei Second People's Hospital

• Ming Jiang · Guilin Municipal Hospital of Traditonal

• Feng Lin · HANNAN GENERAL HOSPITAL

• Chengfang Zheng · Hainan Western Central Hospital

• Zhentao Gu · Heyuan people's Hospital

• Fan Li · THE PEOPLE'S HOSPITAL of HEZHOU

• Qin Yan · Huazhong University of Science and Technology Union Shenzhen Hospital

• Zhanzhou Lin · Huizhou Municipal Central Hospital

• Hui Chen · Hepatobiliary Hospital Of JiLin

• Xujing Liang · First Affiliated Hospital of Jinan University

• Bin Liu · The Affiliated Shunde Hospital of Jinan University

• Changzheng Hu · Jiangmen Central Hospital

• Xingchuan Wang · The 924th Hospital of the PLA joint Logistic support Force

• Chengzu Lin · Jinjiang City Hospital

• Guihua Su · the First People's Hopistal of Kashi

• Yi Wang · Karamay Central Hospital of Xinjiang

• Yuqin Xu · The 962th Hospital of the PLA joint Logistic support Force

• Lingyi Zhang · Lanzhou University Second Hospital

• Xiaorong Mao · LanZhou University

• Hong Wan · Lanzhou University Second Hospital

• Qian Guo · LIU ZHOU WORKER'S HOSPITAL

• Liu He · LIU ZHOU PEOPLE'S HOSPITAL

• Zhengxiao Zhao · LIU ZHOU TRADITIONAL CHINESE MEDICAL HOSPITAL

• Yan Lincan · Long yan hospital of traditional Chinese medicine

• Feng Min · army 73rd group military hospital

• Xiqiu Zeng · Mudanjiang Kangan Hospital

• Shuilin Sun · Second Affiliated Hospital of Nanchang University

• Xiaoping Wu · The First Affiliated Hospital of Nanchang University

• Keqin Zhang · The Ninth Hospital of Nanchang

• Hong Li · Southern Medical University, China

• Jianzhen Yao · Putian Hanjiang Hospital

• Liqin Cai · The First Hospital of Putian City

• Rongxian Qiu · The Affiliated Hospital of Putian University

• Sandu Liu · The People's Hospital Of QianNan

• Qinghua Lu · The Fourth People's Hospital of Qinghai Province

• Ying Deng · The Sixth Affiliated Hospital of Guangzhou Medical University

• Xingnan Pan · Quanzhou Decheng hospital

• Ruyi Guo · Quanzhou First Hospital

• Wenke Li · Quanzhou Hospital of traditional Chinese Medicine

• Huiwen Song · SanMing First Hospital

• Xiulan Xue · The First Affiliated Hospital of Xiamen University

• Qianguo Mao · Xiamen Hospital of Traditional Chinese Medicine

• Haidong Zhao · Xiamen Chang gung hospital

• Yanhui Zu · Shan dong public Health Clinical Center

• Ruilie Chen · Shantou Central Hospital

• Shu Yang · Shenzhen Bao'an People's Hospital

• Jun Chen · Shenzhen Third People's Hospital

• Yanyao Yin · Shenzhen Luohu Hospitai of Traditional Chinese Medicine

• Rongshan Fan · Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

• Guangdong Tong · SHEN ZHEN TRADITIONAL CHINESE MEDICINE HOSPITAL

• Weize Zuo · The First Affiliated Hospital of Shihezi University School of Medicine

• Bin Zhou · Weihai Chest Hospital

• Huanwei Zheng · Shijiazhuang Hospital of Traditional Chinese Medicine

• Chuantiao Zhang · Shishi General Hospital

• Qing Ye · Tianjin Third Central Hospital

• Xin Chen · Tianjin First Hospital

• Changxia Niu · Tianshui First people's hospital

• Jiancheng Zhang · Tianshui traditional Chinese medicine hospital

• Ruihai Zhu · Weifang People's Hospital

• Zhushi Liang · The Third People's Hospital of Wuzhou

• Qingming Zheng · Fujian Xianyou General Hospital

• Xiaobo Lu · First Affiliated Hospital of Xinjiang Medical University

• Xiaozhong Wang · Traditional Chinese Medicine Hospital of Xinjiang

• Huanwen Chen · XING AN COUNTY PEOPLE'S HOSPITSL

• Haifeng Yu · YANTAI QISHAN HOSPITAL

• Shengtao Zeng · Yili Prefecture Infectious Disease Hospital

• Lei Li · Anhui Provincial Hospital

• Weibing Shi · The First Affiliated Hospital of Anhui University of Chinese Medicine

• Chuanmiao Liu · The First Affiliated Hospital of Bengbu Medical University

• Mei Cai · Cangzhou Third Hospital

• Lijuan Guan · The 2nd Hospital of da qing City

• Riwang Hu · The 4th People's Hospital of da tong city

• Jianli Huang · Yongchun County Hospital

• Yueyong Zhu · First Affiliated Hospital of Fujian Medical University

• Minghua Lin · Mengchao Hepatobiliary Hospital of Hujian Medical University

• Ming Li · No.2 People's Hospital of Fuyang City

• Xianqiu Huang · Guidong People's Hospital of Guangxi Zhuang Autonomous Region

• Liying Zhu · The Second Affiliated Hospital of Harbin Medical University

• Lei Yu · The Fourth Affiliated Hospital of Harbin Medical University

• Baoshan Yang · First Affiliated Hospital of Harbin Medical University

• Yuguo Zhang · The First Hospital of Hebei Medical University

• Xiaoli Hu · Heilongjiang provincial hospital

• Weizhong Yan · Jilin Central General Hospital

• Xinsheng Xie · Affiliated Hospital of Jiaxing University

• Caihua Jiang · FUJIAN JIANOU HOSPITAL

• Guoqi Hu · Jieshou City People's Hospital

• Junmei Han · THE THIRD HOSPITAL OF JIN CHENG

• Deshun Yu · JIN CHENG PEOPLE'S HOSPITAL

• Jianqi Lian · Tang-Du Hospital

• Jiuping Wang · Xijing Hospital

• Zhengjun Xu · The 910th Hospital

• Fenxiang Li · LIN FEN THIRD PEOPLE'S HOSPITAL

• Tonghe Wu · THE SECOND HOSPITAL OF LONGYAN

• Fen Wu · JIANYANG FIRST HOSPITAL OF NANPING

• Yun Wu · The Affiliated Hospital of Inner Mongolia Medical University

• Houxiong Lin · Ningde Municipal Hospital of Ningde Normal University

• Yongyue Deng · Zhongshan Hospital Xiamen University

• Xiao Wang · Digestive Diseases Hospital of Shandong First Medical University

• Huaizhang Li · Shanxi Traditional Chinese Medical Hospital

• Liaoyun Zhang · The First Affiliated Hospital of Shanxi Medical University

• Binhong Fu · Shaowu Municiple Hospital of Fujian Province

• Ye Gu · The Sixth People's Hospital of Shenyang

• Ying Guo · The Third People's Hospital of Taiyuan

• Ping Li · Tianjin Second People's Hospital

• Zhifeng Li · TONG LIAO INFECTIOUS DISEASES HOSPITAL

• Jingning Zhao · SINOPHARM TONGMEI GENERAL HOSPITAL

• Shuangsuo Dang · The Second Affiliated Hospital of Ｘi'an Jiaotong University

• Shumei Lin · The First Affiliated Hospital of Ｘi'an Jiaotong University

• Hongxin Pu · Yanbian University Hospital

• Li Zhang · The Sixth hospital of Handan City

• Yongmei Lin · Hanzhong 3201 Hospital

• Chunzhi Su · Hebei Hospital of Traditional Chinese Medicine

• Mingxia Jiang · Jiamusi Infectious Disease Hospital

• Chengrun Xu · Southeast Hospital affiliated to Xiamen University

• Ying Dai · The 7th Hospital of Qiqihar

• Jiansheng Huang · Wuping County Hospital

• Qingrui Peng · Xiapu County Hospital

• Weixin Wang · The 2nd Affiliated Hospital of YCU

• Zhigang Lin · SanMing Yongan General Hospital

• Shihong Wu · Yuncheng Central Hospital

• Zhongfu Zhao · Changzhi Medical College

• Yi Zheng · Xinhua Hospital of Zhejiang Province

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-08

Primary Completion

2026-12-13

Completion

2029-11-30

Countries

• China

Study Locations