Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

NCT ID: NCT05182463

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-08

Study Completion Date

2029-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequential Combination Group

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.

Group Type EXPERIMENTAL

Peginterferon Alfa-2B

Intervention Type DRUG

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.

Nucleoside Analogs

Intervention Type DRUG

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

Initial Combination Group

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.

Group Type EXPERIMENTAL

Peginterferon Alfa-2B

Intervention Type DRUG

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.

Nucleoside Analogs

Intervention Type DRUG

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

Whole-course Combination Group

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

Group Type EXPERIMENTAL

Peginterferon Alfa-2B

Intervention Type DRUG

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.

Nucleoside Analogs

Intervention Type DRUG

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

Peginterferon Monotherapy Group

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

Group Type EXPERIMENTAL

Peginterferon Alfa-2B

Intervention Type DRUG

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.

NAs Monotherapy Group

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

Group Type EXPERIMENTAL

Nucleoside Analogs

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Nucleoside Analogs

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhiliang Gao

Director of the infectious diseases department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhiliang Gao, Doctor

Role: STUDY_CHAIR

Third Affiliated Hospital, Sun Yat-Sen University

Guizhou Zou

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Jiabin Li

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Anhui Medical University

Zhende Lin

Role: PRINCIPAL_INVESTIGATOR

Anxi County Hospital

Guoxin Hu

Role: PRINCIPAL_INVESTIGATOR

SHENZHEN HOSPITAL of PEKING UNIVERSITY

Youping Lin

Role: PRINCIPAL_INVESTIGATOR

Dongguan Binhai Bay Central Hospital

Sichun Yin

Role: PRINCIPAL_INVESTIGATOR

Dongguan Ninth People's Hospital

Songmei He

Role: PRINCIPAL_INVESTIGATOR

Dongguan People's Hospital

Zengjia Xu

Role: PRINCIPAL_INVESTIGATOR

Dongyuan People's Hospital

Hui Shen

Role: PRINCIPAL_INVESTIGATOR

DuShanZi People's Hospital

Haifei Luo

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Foshan

Wenhua Zhang

Role: PRINCIPAL_INVESTIGATOR

Gansu Wuwei Tumor Hospital

Maosheng Wu

Role: PRINCIPAL_INVESTIGATOR

Guangdong Second Provincial People's Hospital

Dong Wei

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Second traditional Chinese Medicine hospital

Wenli Chen

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Bihua Gao

Role: PRINCIPAL_INVESTIGATOR

Beihai People's hospital

Guifang Tang

Role: PRINCIPAL_INVESTIGATOR

Nanxishan Hospital of Giang xi zhuang Autonomous Region

Huaiyu Song

Role: PRINCIPAL_INVESTIGATOR

THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTCNOMOUS REGION

Zhuxiang Zhao

Role: PRINCIPAL_INVESTIGATOR

The First Municipal Hospital of Guangzhou

Xihua Fu

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Panyu Central Hospital

Runqi Luo

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Shi Ouyang

Role: PRINCIPAL_INVESTIGATOR

Fifth Affiliated Hospital of Guangzhou Medical University

Chunlan Zhang

Role: PRINCIPAL_INVESTIGATOR

GUANGZHOU EIGHTH PEOPLE'S HOSPITAL GUANGZHOU MEDICAL UNIVERSITY

Riying Lv

Role: PRINCIPAL_INVESTIGATOR

Guigang city People's Hospital

Bigang Xiong

Role: PRINCIPAL_INVESTIGATOR

GuiYang Public Health Clinlcal Center

Hong Peng

Role: PRINCIPAL_INVESTIGATOR

the People's Hospital of Guizhou

Sufen Zhou

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Quan Zhang

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital Of Guizhou Medical University

YongChao Xian

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Guilin

Ganwen Li

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated Hospital of Sun Yat-Sen Unlversity Yuedong hospital

Jinyu Xia

Role: PRINCIPAL_INVESTIGATOR

The Fifth Affiliated Hospital, Sun Yat-sen University

Bihui Zhong

Role: PRINCIPAL_INVESTIGATOR

The First Afiliated Hospital Sun Yat-sen University

Minhui Xiao

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Wenjun Gao

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Sencond People's Hospital

Gang Li

Role: PRINCIPAL_INVESTIGATOR

The fourth people's Hospital of Zibo

Yangwen Luo

Role: PRINCIPAL_INVESTIGATOR

Zunyi Medical College

Jie Chen

Role: PRINCIPAL_INVESTIGATOR

The Second People's Hospital OF YULIN

Xiaochao Qin

Role: PRINCIPAL_INVESTIGATOR

Red Cross Hospital of Yulin City

Wuhai Qin

Role: PRINCIPAL_INVESTIGATOR

teaditional chinese medicine hospital of YULIN

Hongshun Fan

Role: PRINCIPAL_INVESTIGATOR

Yuebei Second People's Hospital

Ming Jiang

Role: PRINCIPAL_INVESTIGATOR

Guilin Municipal Hospital of Traditonal

Feng Lin

Role: PRINCIPAL_INVESTIGATOR

HANNAN GENERAL HOSPITAL

Chengfang Zheng

Role: PRINCIPAL_INVESTIGATOR

Hainan Western Central Hospital

Zhentao Gu

Role: PRINCIPAL_INVESTIGATOR

Heyuan people's Hospital

Fan Li

Role: PRINCIPAL_INVESTIGATOR

THE PEOPLE'S HOSPITAL of HEZHOU

Qin Yan

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology Union Shenzhen Hospital

Zhanzhou Lin

Role: PRINCIPAL_INVESTIGATOR

Huizhou Municipal Central Hospital

Hui Chen

Role: PRINCIPAL_INVESTIGATOR

Hepatobiliary Hospital Of JiLin

Xujing Liang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Jinan University

Bin Liu

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Shunde Hospital of Jinan University

Changzheng Hu

Role: PRINCIPAL_INVESTIGATOR

Jiangmen Central Hospital

Xingchuan Wang

Role: PRINCIPAL_INVESTIGATOR

The 924th Hospital of the PLA joint Logistic support Force

Chengzu Lin

Role: PRINCIPAL_INVESTIGATOR

Jinjiang City Hospital

Guihua Su

Role: PRINCIPAL_INVESTIGATOR

the First People's Hopistal of Kashi

Yi Wang

Role: PRINCIPAL_INVESTIGATOR

Karamay Central Hospital of Xinjiang

Yuqin Xu

Role: PRINCIPAL_INVESTIGATOR

The 962th Hospital of the PLA joint Logistic support Force

Lingyi Zhang

Role: PRINCIPAL_INVESTIGATOR

Lanzhou University Second Hospital

Xiaorong Mao

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Hong Wan

Role: PRINCIPAL_INVESTIGATOR

Lanzhou University Second Hospital

Qian Guo

Role: PRINCIPAL_INVESTIGATOR

LIU ZHOU WORKER'S HOSPITAL

Liu He

Role: PRINCIPAL_INVESTIGATOR

LIU ZHOU PEOPLE'S HOSPITAL

Zhengxiao Zhao

Role: PRINCIPAL_INVESTIGATOR

LIU ZHOU TRADITIONAL CHINESE MEDICAL HOSPITAL

Yan Lincan

Role: PRINCIPAL_INVESTIGATOR

Long yan hospital of traditional Chinese medicine

Feng Min

Role: PRINCIPAL_INVESTIGATOR

army 73rd group military hospital

Xiqiu Zeng

Role: PRINCIPAL_INVESTIGATOR

Mudanjiang Kangan Hospital

Shuilin Sun

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Nanchang University

Xiaoping Wu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Keqin Zhang

Role: PRINCIPAL_INVESTIGATOR

The Ninth Hospital of Nanchang

Hong Li

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Jianzhen Yao

Role: PRINCIPAL_INVESTIGATOR

Putian Hanjiang Hospital

Liqin Cai

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Putian City

Rongxian Qiu

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Putian University

Sandu Liu

Role: PRINCIPAL_INVESTIGATOR

The People's Hospital Of QianNan

Qinghua Lu

Role: PRINCIPAL_INVESTIGATOR

The Fourth People's Hospital of Qinghai Province

Ying Deng

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital of Guangzhou Medical University

Xingnan Pan

Role: PRINCIPAL_INVESTIGATOR

Quanzhou Decheng hospital

Ruyi Guo

Role: PRINCIPAL_INVESTIGATOR

Quanzhou First Hospital

Wenke Li

Role: PRINCIPAL_INVESTIGATOR

Quanzhou Hospital of traditional Chinese Medicine

Huiwen Song

Role: PRINCIPAL_INVESTIGATOR

SanMing First Hospital

Xiulan Xue

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Xiamen University

Qianguo Mao

Role: PRINCIPAL_INVESTIGATOR

Xiamen Hospital of Traditional Chinese Medicine

Haidong Zhao

Role: PRINCIPAL_INVESTIGATOR

Xiamen Chang gung hospital

Yanhui Zu

Role: PRINCIPAL_INVESTIGATOR

Shan dong public Health Clinical Center

Ruilie Chen

Role: PRINCIPAL_INVESTIGATOR

Shantou Central Hospital

Shu Yang

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Bao'an People's Hospital

Jun Chen

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People's Hospital

Yanyao Yin

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Luohu Hospitai of Traditional Chinese Medicine

Rongshan Fan

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

Guangdong Tong

Role: PRINCIPAL_INVESTIGATOR

SHEN ZHEN TRADITIONAL CHINESE MEDICINE HOSPITAL

Weize Zuo

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shihezi University School of Medicine

Bin Zhou

Role: PRINCIPAL_INVESTIGATOR

Weihai Chest Hospital

Huanwei Zheng

Role: PRINCIPAL_INVESTIGATOR

Shijiazhuang Hospital of Traditional Chinese Medicine

Chuantiao Zhang

Role: PRINCIPAL_INVESTIGATOR

Shishi General Hospital

Qing Ye

Role: PRINCIPAL_INVESTIGATOR

Tianjin Third Central Hospital

Xin Chen

Role: PRINCIPAL_INVESTIGATOR

Tianjin First Hospital

Changxia Niu

Role: PRINCIPAL_INVESTIGATOR

Tianshui First people's hospital

Jiancheng Zhang

Role: PRINCIPAL_INVESTIGATOR

Tianshui traditional Chinese medicine hospital

Ruihai Zhu

Role: PRINCIPAL_INVESTIGATOR

Weifang People's Hospital

Zhushi Liang

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Wuzhou

Qingming Zheng

Role: PRINCIPAL_INVESTIGATOR

Fujian Xianyou General Hospital

Xiaobo Lu

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xinjiang Medical University

Xiaozhong Wang

Role: PRINCIPAL_INVESTIGATOR

Traditional Chinese Medicine Hospital of Xinjiang

Huanwen Chen

Role: PRINCIPAL_INVESTIGATOR

XING AN COUNTY PEOPLE'S HOSPITSL

Haifeng Yu

Role: PRINCIPAL_INVESTIGATOR

YANTAI QISHAN HOSPITAL

Shengtao Zeng

Role: PRINCIPAL_INVESTIGATOR

Yili Prefecture Infectious Disease Hospital

Lei Li

Role: PRINCIPAL_INVESTIGATOR

Anhui Provincial Hospital

Weibing Shi

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Anhui University of Chinese Medicine

Chuanmiao Liu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Bengbu Medical University

Mei Cai

Role: PRINCIPAL_INVESTIGATOR

Cangzhou Third Hospital

Lijuan Guan

Role: PRINCIPAL_INVESTIGATOR

The 2nd Hospital of da qing City

Riwang Hu

Role: PRINCIPAL_INVESTIGATOR

The 4th People's Hospital of da tong city

Jianli Huang

Role: PRINCIPAL_INVESTIGATOR

Yongchun County Hospital

Yueyong Zhu

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Minghua Lin

Role: PRINCIPAL_INVESTIGATOR

Mengchao Hepatobiliary Hospital of Hujian Medical University

Ming Li

Role: PRINCIPAL_INVESTIGATOR

No.2 People's Hospital of Fuyang City

Xianqiu Huang

Role: PRINCIPAL_INVESTIGATOR

Guidong People's Hospital of Guangxi Zhuang Autonomous Region

Liying Zhu

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Harbin Medical University

Lei Yu

Role: PRINCIPAL_INVESTIGATOR

The Fourth Affiliated Hospital of Harbin Medical University

Baoshan Yang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Yuguo Zhang

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Xiaoli Hu

Role: PRINCIPAL_INVESTIGATOR

Heilongjiang provincial hospital

Weizhong Yan

Role: PRINCIPAL_INVESTIGATOR

Jilin Central General Hospital

Xinsheng Xie

Role: PRINCIPAL_INVESTIGATOR

Affiliated Hospital of Jiaxing University

Caihua Jiang

Role: PRINCIPAL_INVESTIGATOR

FUJIAN JIANOU HOSPITAL

Guoqi Hu

Role: PRINCIPAL_INVESTIGATOR

Jieshou City People's Hospital

Junmei Han

Role: PRINCIPAL_INVESTIGATOR

THE THIRD HOSPITAL OF JIN CHENG

Deshun Yu

Role: PRINCIPAL_INVESTIGATOR

JIN CHENG PEOPLE'S HOSPITAL

Jianqi Lian

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

Jiuping Wang

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Zhengjun Xu

Role: PRINCIPAL_INVESTIGATOR

The 910th Hospital

Fenxiang Li

Role: PRINCIPAL_INVESTIGATOR

LIN FEN THIRD PEOPLE'S HOSPITAL

Tonghe Wu

Role: PRINCIPAL_INVESTIGATOR

THE SECOND HOSPITAL OF LONGYAN

Fen Wu

Role: PRINCIPAL_INVESTIGATOR

JIANYANG FIRST HOSPITAL OF NANPING

Yun Wu

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Inner Mongolia Medical University

Houxiong Lin

Role: PRINCIPAL_INVESTIGATOR

Ningde Municipal Hospital of Ningde Normal University

Yongyue Deng

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital Xiamen University

Xiao Wang

Role: PRINCIPAL_INVESTIGATOR

Digestive Diseases Hospital of Shandong First Medical University

Huaizhang Li

Role: PRINCIPAL_INVESTIGATOR

Shanxi Traditional Chinese Medical Hospital

Liaoyun Zhang

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shanxi Medical University

Binhong Fu

Role: PRINCIPAL_INVESTIGATOR

Shaowu Municiple Hospital of Fujian Province

Ye Gu

Role: PRINCIPAL_INVESTIGATOR

The Sixth People's Hospital of Shenyang

Ying Guo

Role: PRINCIPAL_INVESTIGATOR

The Third People's Hospital of Taiyuan

Ping Li

Role: PRINCIPAL_INVESTIGATOR

Tianjin Second People's Hospital

Zhifeng Li

Role: PRINCIPAL_INVESTIGATOR

TONG LIAO INFECTIOUS DISEASES HOSPITAL

Jingning Zhao

Role: PRINCIPAL_INVESTIGATOR

SINOPHARM TONGMEI GENERAL HOSPITAL

Shuangsuo Dang

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Xi'an Jiaotong University

Shumei Lin

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Xi'an Jiaotong University

Hongxin Pu

Role: PRINCIPAL_INVESTIGATOR

Yanbian University Hospital

Li Zhang

Role: PRINCIPAL_INVESTIGATOR

The Sixth hospital of Handan City

Yongmei Lin

Role: PRINCIPAL_INVESTIGATOR

Hanzhong 3201 Hospital

Chunzhi Su

Role: PRINCIPAL_INVESTIGATOR

Hebei Hospital of Traditional Chinese Medicine

Mingxia Jiang

Role: PRINCIPAL_INVESTIGATOR

Jiamusi Infectious Disease Hospital

Chengrun Xu

Role: PRINCIPAL_INVESTIGATOR

Southeast Hospital affiliated to Xiamen University

Ying Dai

Role: PRINCIPAL_INVESTIGATOR

The 7th Hospital of Qiqihar

Jiansheng Huang

Role: PRINCIPAL_INVESTIGATOR

Wuping County Hospital

Qingrui Peng

Role: PRINCIPAL_INVESTIGATOR

Xiapu County Hospital

Weixin Wang

Role: PRINCIPAL_INVESTIGATOR

The 2nd Affiliated Hospital of YCU

Zhigang Lin

Role: PRINCIPAL_INVESTIGATOR

SanMing Yongan General Hospital

Shihong Wu

Role: PRINCIPAL_INVESTIGATOR

Yuncheng Central Hospital

Zhongfu Zhao

Role: PRINCIPAL_INVESTIGATOR

Changzhi Medical College

Yi Zheng

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital of Zhejiang Province

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhishuo Mo, Master

Role: CONTACT

+86 13632434363

Facility Contacts

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Zhi-Liang Gao, Professor

Role: primary

86-20-85252373

Xiang Zhu, Doctor

Role: backup

86-20-85252372

References

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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.

Reference Type BACKGROUND
PMID: 27239256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28407271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33896094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23246508 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34350562 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32626791 (View on PubMed)

Chang LJ, Hao CQ, Rao GR, Xu LL, Li J, Cheng Y, Zheng LJ, Wu CW, Chen HX, Chen ZR, Lian JQ, Wu SH, Luo LM, Zhang WL, Zhang Y. Recurrence risk factors for chronic hepatitis B virus-infected patients who achieve functional cure with pegylated interferon-alpha-2b-based therapy: a multicenter pilot study. Virol J. 2025 May 19;22(1):146. doi: 10.1186/s12985-025-02761-3.

Reference Type DERIVED
PMID: 40390028 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

[2021]02-373-01

Identifier Type: -

Identifier Source: org_study_id

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