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Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

Primary Purpose

Hepatitis B, Chronic

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Peginterferon Alfa-2B
Nucleoside Analogs
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring inactive chronic hepatitis B, functional cure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18-60, no gender limitation
  • HBsAg is positive for more than 6 months
  • Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive
  • Serum HBV DNA is less than 2000 IU/mL
  • Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal
  • No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment
  • Good compliance and voluntarily signed informed consent

Exclusion Criteria:

  • Allergic to pegylated interferon α-2b
  • Any indication of liver cirrhosis
  • Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV)
  • Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.)
  • There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus
  • Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism)
  • Confirmed or suspected liver cancer or other malignant tumors
  • Patients after or preparing for organ transplantation
  • Peripheral blood white blood cell count < 3.5×109/L and/or platelet count < 80×109/L
  • Under immunosuppressant treatment
  • Pregnant or planned pregnancy in a short term or lactation patients
  • Alcohol abuse (average alcohol intake is more than 40 g/d in males or 20g/d in women) or drug addicts
  • Present or past history of mental or psychological diseases
  • Other conditions that the investigators deem inappropriate for the study.

Sites / Locations

  • Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequential Combination Group

Initial Combination Group

Whole-course Combination Group

Peginterferon Monotherapy Group

NAs Monotherapy Group

Arm Description

Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks, followed by combination therapy with peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.

NAs combined with peginterferon are used for 12-24 weeks, followed by peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.

NAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks.

Peginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.

NAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.

Outcomes

Primary Outcome Measures

HBsAg clearance rate
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml

Secondary Outcome Measures

HBsAg serological conversion rate
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
The magnitude of HBsAg decline from baseline
HBsAg is detected by quantitative assays from Roche or Abbott
The magnitude of HBV-DNA decline from baseline and the undetectable rate
HBV-DNA is detected by assays from Roche or Abbott, of which the lower limit is 15 or 10 IU/ml.
HBsAg clearance rate, HBsAg serological conversion rate and maintenance response rate of HBsAg clearance
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml

Full Information

First Posted
December 18, 2021
Last Updated
April 1, 2022
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05182463
Brief Title
Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients
Official Title
Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2022 (Actual)
Primary Completion Date
December 13, 2026 (Anticipated)
Study Completion Date
November 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
inactive chronic hepatitis B, functional cure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential Combination Group
Arm Type
Experimental
Arm Description
Oral nucleos(t)ide analogues (NAs) (Entecavir(ETV), Tenofovir disoproxil fumarate tablets(TDF) or Tenofovir Alafenamide Fumarate(TAF)) is used for 12-24 weeks, followed by combination therapy with peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.
Arm Title
Initial Combination Group
Arm Type
Experimental
Arm Description
NAs combined with peginterferon are used for 12-24 weeks, followed by peginterferon α-2b. The Maximum course is 96 weeks. Follow-up period is 144 weeks.
Arm Title
Whole-course Combination Group
Arm Type
Experimental
Arm Description
NAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Arm Title
Peginterferon Monotherapy Group
Arm Type
Experimental
Arm Description
Peginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Arm Title
NAs Monotherapy Group
Arm Type
Experimental
Arm Description
NAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2B
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nucleoside Analogs
Intervention Description
Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.
Primary Outcome Measure Information:
Title
HBsAg clearance rate
Description
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
Time Frame
From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks
Secondary Outcome Measure Information:
Title
HBsAg serological conversion rate
Description
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
Time Frame
From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks
Title
The magnitude of HBsAg decline from baseline
Description
HBsAg is detected by quantitative assays from Roche or Abbott
Time Frame
through treatment completion, an anticipated period of 96 weeks
Title
The magnitude of HBV-DNA decline from baseline and the undetectable rate
Description
HBV-DNA is detected by assays from Roche or Abbott, of which the lower limit is 15 or 10 IU/ml.
Time Frame
through treatment completion, an anticipated period of 96 weeks
Title
HBsAg clearance rate, HBsAg serological conversion rate and maintenance response rate of HBsAg clearance
Description
HBsAg is detected by Roche or Abbott productions, of which the lower limit is 0.05 IU/ml
Time Frame
through follow-up completion, an anticipated period of 144 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-60, no gender limitation HBsAg is positive for more than 6 months Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive Serum HBV DNA is less than 2000 IU/mL Alanine aminotransferase(ALT) and/or Aspartate aminotransferase(AST) is normal No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment Good compliance and voluntarily signed informed consent Exclusion Criteria: Allergic to pegylated interferon α-2b Any indication of liver cirrhosis Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV) Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.) There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism) Confirmed or suspected liver cancer or other malignant tumors Patients after or preparing for organ transplantation Peripheral blood white blood cell count < 3.5×109/L and/or platelet count < 80×109/L Under immunosuppressant treatment Pregnant or planned pregnancy in a short term or lactation patients Alcohol abuse (average alcohol intake is more than 40 g/d in males or 20g/d in women) or drug addicts Present or past history of mental or psychological diseases Other conditions that the investigators deem inappropriate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhishuo Mo, Master
Phone
+86 13632434363
Email
vbstone@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhiliang Gao, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Guizhou Zou
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiabin Li
Organizational Affiliation
The First Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhende Lin
Organizational Affiliation
Anxi County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guoxin Hu
Organizational Affiliation
SHENZHEN HOSPITAL of PEKING UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Youping Lin
Organizational Affiliation
Dongguan Binhai Bay Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sichun Yin
Organizational Affiliation
Dongguan Ninth People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Songmei He
Organizational Affiliation
Dongguan People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zengjia Xu
Organizational Affiliation
Dongyuan People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Shen
Organizational Affiliation
DuShanZi People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haifei Luo
Organizational Affiliation
First People's Hospital of Foshan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenhua Zhang
Organizational Affiliation
Gansu Wuwei Tumour Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maosheng Wu
Organizational Affiliation
Guangdong Second Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong Wei
Organizational Affiliation
Guangzhou Second traditional Chinese Medicine hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenli Chen
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bihua Gao
Organizational Affiliation
Beihai People's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guifang Tang
Organizational Affiliation
Nanxishan Hospital of Giang xi zhuang Autonomous Region
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huaiyu Song
Organizational Affiliation
THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTCNOMOUS REGION
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhuxiang Zhao
Organizational Affiliation
The First Municipal Hospital of Guangzhou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xihua Fu
Organizational Affiliation
Guangzhou Panyu Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Runqi Luo
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shi Ouyang
Organizational Affiliation
Fifth Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunlan Zhang
Organizational Affiliation
GUANGZHOU EIGHTH PEOPLE'S HOSPITAL GUANGZHOU MEDICAL UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riying Lv
Organizational Affiliation
Guigang city People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bigang Xiong
Organizational Affiliation
GuiYang Public Health Clinlcal Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Peng
Organizational Affiliation
the People's Hospital of Guizhou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sufen Zhou
Organizational Affiliation
The First Affiliated Hospital of Guizhou University of traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Quan Zhang
Organizational Affiliation
The Affiliated Hospital Of Guizhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YongChao Xian
Organizational Affiliation
The Third People's Hospital of Guilin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ganwen Li
Organizational Affiliation
The Third Affiliated Hospital of Sun Yat-Sen Unlversity Yuedong hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jinyu Xia
Organizational Affiliation
The Fifth Affiliated Hospital Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bihui Zhong
Organizational Affiliation
The First Afiliated Hospital Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Minhui Xiao
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenjun Gao
Organizational Affiliation
Zhongshan Sencond People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gang Li
Organizational Affiliation
The fourth people's Hospital of Zibo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yangwen Luo
Organizational Affiliation
Zunyi Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Chen
Organizational Affiliation
The Second People's Hospital OF YULIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaochao Qin
Organizational Affiliation
Red Cross Hospital of Yulin City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wuhai Qin
Organizational Affiliation
teaditional chinese medicine hospital of YULIN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongshun Fan
Organizational Affiliation
Yuebei Second People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Jiang
Organizational Affiliation
Guilin Municipal Hospital of Traditonal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Lin
Organizational Affiliation
HANNAN GENERAL HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chengfang Zheng
Organizational Affiliation
Hainan Western Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhentao Gu
Organizational Affiliation
Heyuan people's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fan Li
Organizational Affiliation
THE PEOPLE'S HOSPITAL of HEZHOU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qin Yan
Organizational Affiliation
Huazhong University of Science and Technology Union Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhanzhou Lin
Organizational Affiliation
Huizhou Municipal Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Chen
Organizational Affiliation
Hepatobiliary Hospital Of JiLin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xujing Liang
Organizational Affiliation
First Affiliated Hospital of Jinan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bin Liu
Organizational Affiliation
THE AFFILIATED SHUNDE HOSPITAL OF JINAN UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changzheng Hu
Organizational Affiliation
Jiangmen Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xingchuan Wang
Organizational Affiliation
The 924th Hospital of the PLA joint Logistic support Force
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chengzu Lin
Organizational Affiliation
Jinjiang City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guihua Su
Organizational Affiliation
the First People's Hopistal of Kashi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi Wang
Organizational Affiliation
Karamay Central Hospital of Xinjiang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuqin Xu
Organizational Affiliation
The 962th Hospital of the PLA joint Logistic support Force
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lingyi Zhang
Organizational Affiliation
Second Hospital of Lanzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaorong Mao
Organizational Affiliation
LanZhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Wan
Organizational Affiliation
Second Hospital of Lanzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qian Guo
Organizational Affiliation
LIU ZHOU WORKER'S HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liu He
Organizational Affiliation
LIU ZHOU PEOPLE'S HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhengxiao Zhao
Organizational Affiliation
LIU ZHOU TRADITIONAL CHINESE MEDICAL HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Lincan
Organizational Affiliation
Long yan hospital of traditional Chinese medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Min
Organizational Affiliation
army 73rd group military hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiqiu Zeng
Organizational Affiliation
Mudanjiang Kangan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shuilin Sun
Organizational Affiliation
Second Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoping Wu
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keqin Zhang
Organizational Affiliation
The Ninth Hospital of Nanchang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Li
Organizational Affiliation
Southern Medical University, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianzhen Yao
Organizational Affiliation
Putian Hanjiang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liqin Cai
Organizational Affiliation
The First Hospital of Putian City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rongxian Qiu
Organizational Affiliation
The Affiliated Hospital of Putian University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandu Liu
Organizational Affiliation
The People's Hospital Of QianNan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qinghua Lu
Organizational Affiliation
The 4th People's Hospital of Qinghai Province
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Deng
Organizational Affiliation
The Sixth Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xingnan Pan
Organizational Affiliation
Quanzhou Decheng hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruyi Guo
Organizational Affiliation
Quanzhou First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenke Li
Organizational Affiliation
Quanzhou Hospital of traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huiwen Song
Organizational Affiliation
SanMing First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiulan Xue
Organizational Affiliation
The First Affiliated Hospital of Xiamen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qianguo Mao
Organizational Affiliation
Xiamen Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haidong Zhao
Organizational Affiliation
Xiamen Chang gung hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanhui Zu
Organizational Affiliation
Shan dong public Health Clinical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruilie Chen
Organizational Affiliation
Shantou Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shu Yang
Organizational Affiliation
Shenzhen Bao'an People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Chen
Organizational Affiliation
Shenzhen Third People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanyao Yin
Organizational Affiliation
Shenzhen Luohu Hospitai of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rongshan Fan
Organizational Affiliation
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guangdong Tong
Organizational Affiliation
SHEN ZHEN TRADITIONAL CHINESE MEDICINE HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weize Zuo
Organizational Affiliation
The First Affiliated Hospital of Shihezi University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bin Zhou
Organizational Affiliation
Weihai Chest Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huanwei Zheng
Organizational Affiliation
Shijiazhuang Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chuantiao Zhang
Organizational Affiliation
Shishi General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Ye
Organizational Affiliation
Tianjin Third Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Chen
Organizational Affiliation
Tianjin First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Changxia Niu
Organizational Affiliation
Tianshui First people's hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiancheng Zhang
Organizational Affiliation
Tianshui traditional Chinese medicine hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruihai Zhu
Organizational Affiliation
Weifang People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhushi Liang
Organizational Affiliation
The Third People's Hospital of Wuzhou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qingming Zheng
Organizational Affiliation
Fujian Xianyou General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaobo Lu
Organizational Affiliation
First Affiliated Hospital of Xinjiang Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaozhong Wang
Organizational Affiliation
Traditional Chinese Medicine Hospital of Xinjiang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huanwen Chen
Organizational Affiliation
XING AN COUNTY PEOPLE'S HOSPITSL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haifeng Yu
Organizational Affiliation
YANTAI QISHAN HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shengtao Zeng
Organizational Affiliation
Yili Prefecture Infectious Disease Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lei Li
Organizational Affiliation
Anhui Provincial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weibing Shi
Organizational Affiliation
The First Affiliated Hospital of Anhui University of Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chuanmiao Liu
Organizational Affiliation
First Affiliated Hospital Bengbu Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mei Cai
Organizational Affiliation
Cangzhou Third Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lijuan Guan
Organizational Affiliation
The 2nd Hospital of da qing City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Riwang Hu
Organizational Affiliation
The 4th People's Hospital of da tong city
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianli Huang
Organizational Affiliation
Yongchun County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yueyong Zhu
Organizational Affiliation
First Affiliated Hospital of Fujian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Minghua Lin
Organizational Affiliation
Mengchao Hepatobiliary Hospital of Hujian Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ming Li
Organizational Affiliation
No.2 People's Hospital of Fuyang City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xianqiu Huang
Organizational Affiliation
Guidong People's Hospital of Guangxi Zhuang Autonomous Region
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liying Zhu
Organizational Affiliation
The Second Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lei Yu
Organizational Affiliation
The Fourth Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Baoshan Yang
Organizational Affiliation
First Affiliated Hospital of Harbin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuguo Zhang
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoli Hu
Organizational Affiliation
Heilongjiang provincial hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weizhong Yan
Organizational Affiliation
Jilin Central General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinsheng Xie
Organizational Affiliation
Affiliated Hospital of Jiaxing University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Caihua Jiang
Organizational Affiliation
FUJIAN JIANOU HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guoqi Hu
Organizational Affiliation
Jieshou City People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Junmei Han
Organizational Affiliation
THE THIRD HOSPITAL OF JIN CHENG
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deshun Yu
Organizational Affiliation
JIN CHENG PEOPLE'S HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianqi Lian
Organizational Affiliation
Tang-Du Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiuping Wang
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhengjun Xu
Organizational Affiliation
THE 910TH HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fenxiang Li
Organizational Affiliation
LIN FEN THIRD PEOPLE'S HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tonghe Wu
Organizational Affiliation
THE SECOND HOSPITAL OF LONGYAN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fen Wu
Organizational Affiliation
JIANYANG FIRST HOSPITAL OF NANPING
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yun Wu
Organizational Affiliation
The Affiliated Hospital of Inner Mongolia Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Houxiong Lin
Organizational Affiliation
Ningde Municipal Hospital of Ningde Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongyue Deng
Organizational Affiliation
Zhongshan Hospital Xiamen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiao Wang
Organizational Affiliation
Digestive Diseases Hospital of Shandong First Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huaizhang Li
Organizational Affiliation
Shanxi Traditional Chinese Medical Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liaoyun Zhang
Organizational Affiliation
The First Affiliated Hospital of Shanxi Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Binhong Fu
Organizational Affiliation
Shaowu Municiple Hospital of Fujian Province
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ye Gu
Organizational Affiliation
The Sixth People's Hospital of Shenyang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Guo
Organizational Affiliation
The Third People's Hospital of Taiyuan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ping Li
Organizational Affiliation
Tianjin Second People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhifeng Li
Organizational Affiliation
TONG LIAO INFECTIOUS DISEASES HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jingning Zhao
Organizational Affiliation
SINOPHARM TONGMEI GENERAL HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shuangsuo Dang
Organizational Affiliation
The Second Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shumei Lin
Organizational Affiliation
The First Affiliated Hospital of Xi'an Jiaotong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hongxin Pu
Organizational Affiliation
Yanbian University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Zhang
Organizational Affiliation
The Sixth hospital of Handan City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongmei Lin
Organizational Affiliation
Hanzhong 3201 Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunzhi Su
Organizational Affiliation
Hebei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mingxia Jiang
Organizational Affiliation
Jiamusi Infectious Disease Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chengrun Xu
Organizational Affiliation
Southeast Hospital affiliated to Xiamen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Dai
Organizational Affiliation
The 7th Hospital of Qiqihar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jiansheng Huang
Organizational Affiliation
Wuping County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qingrui Peng
Organizational Affiliation
Xiapu County Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weixin Wang
Organizational Affiliation
The 2nd Affiliated Hospital of YCU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhigang Lin
Organizational Affiliation
SanMing Yongan General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shihong Wu
Organizational Affiliation
Yuncheng Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhongfu Zhao
Organizational Affiliation
Changzhi Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi Zheng
Organizational Affiliation
Xinhua Hospital of Zhejiang Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi-Liang Gao, Professor
Phone
86-20-85252373
Email
zhilianggao@21cn.com
First Name & Middle Initial & Last Name & Degree
Xiang Zhu, Doctor
Phone
86-20-85252372
Email
0628zhuxiang@163.com
First Name & Middle Initial & Last Name & Degree
Zhi-Liang Gao, Professor
First Name & Middle Initial & Last Name & Degree
Qi-Huan Xu, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data would be available to other researchers with the approval of the ethics committee
Citations:
PubMed Identifier
27239256
Citation
Li MH, Xie Y, Zhang L, Lu Y, Shen G, Wu SL, Chang M, Mu CQ, Hu LP, Hua WH, Song SJ, Zhang SF, Cheng J, Xu DZ. Hepatitis B surface antigen clearance in inactive hepatitis B surface antigen carriers treated with peginterferon alfa-2a. World J Hepatol. 2016 May 28;8(15):637-43. doi: 10.4254/wjh.v8.i15.637.
Results Reference
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PubMed Identifier
28407271
Citation
Cao Z, Liu Y, Ma L, Lu J, Jin Y, Ren S, He Z, Shen C, Chen X. A potent hepatitis B surface antigen response in subjects with inactive hepatitis B surface antigen carrier treated with pegylated-interferon alpha. Hepatology. 2017 Oct;66(4):1058-1066. doi: 10.1002/hep.29213. Epub 2017 Aug 26.
Results Reference
background
PubMed Identifier
33896094
Citation
Wu F, Lu R, Liu Y, Wang Y, Tian Y, Li Y, Li M, Wang W, Zhang X, Jia X, Dang S. Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers. Liver Int. 2021 Sep;41(9):2032-2045. doi: 10.1111/liv.14897. Epub 2021 May 26.
Results Reference
background
PubMed Identifier
23246508
Citation
Liu J, Lee MH, Batrla-Utermann R, Jen CL, Iloeje UH, Lu SN, Wang LY, You SL, Hsiao CK, Yang HI, Chen CJ. A predictive scoring system for the seroclearance of HBsAg in HBeAg-seronegative chronic hepatitis B patients with genotype B or C infection. J Hepatol. 2013 May;58(5):853-60. doi: 10.1016/j.jhep.2012.12.006. Epub 2012 Dec 13.
Results Reference
background
PubMed Identifier
34350562
Citation
Huang Y, Qi M, Liao C, Xun J, Zou J, Huang H, Long LY, Chen J, Fan X, Chen R. Analysis of the Efficacy and Safety of PEGylated Interferon-alpha2b Treatment in Inactive Hepatitis B Surface Antigen Carriers. Infect Dis Ther. 2021 Dec;10(4):2323-2331. doi: 10.1007/s40121-021-00511-w. Epub 2021 Aug 4.
Results Reference
background
PubMed Identifier
32626791
Citation
Zeng QL, Yu ZJ, Shang J, Xu GH, Sun CY, Liu N, Li CX, Lv J, Liu YM, Liang HX, Li ZQ, Pan YJ, Hu QY, Li W, Zhang DW, Wang FS. Short-term Peginterferon-Induced High Functional Cure Rate in Inactive Chronic Hepatitis B Virus Carriers With Low Surface Antigen Levels. Open Forum Infect Dis. 2020 Jun 3;7(6):ofaa208. doi: 10.1093/ofid/ofaa208. eCollection 2020 Jun.
Results Reference
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Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

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