Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

NCT05182463 | Recruiting Phase 4 DMC

• 1 other identifier: [2021]02-373-01
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B, Chronic

Keywords

inactive chronic hepatitis B; functional cure

Outcome Measures

Primary Outcomes (1)

• HBsAg clearance rate

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

  From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks

Secondary Outcomes (4)

• HBsAg serological conversion rate

  From date of the beginning of treatment until the date of the end of treatment, assessed up to 96 weeks

• The magnitude of HBsAg decline from baseline

  through treatment completion, an anticipated period of 96 weeks

• The magnitude of HBV-DNA decline from baseline and the undetectable rate

  through treatment completion, an anticipated period of 96 weeks

• HBsAg clearance rate, HBsAg serological conversion rate and maintenance response rate of HBsAg clearance

  through follow-up completion, an anticipated period of 144 weeks

Study Arms (5)

Sequential Combination Group

EXPERIMENTAL

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.

Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs

Initial Combination Group

EXPERIMENTAL

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.

Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs

Whole-course Combination Group

EXPERIMENTAL

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

Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs

Peginterferon Monotherapy Group

EXPERIMENTAL

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

Drug: Peginterferon Alfa-2B

NAs Monotherapy Group

EXPERIMENTAL

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

Drug: Nucleoside Analogs

Interventions

Peginterferon Alfa-2B 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.

Initial Combination Group; Peginterferon Monotherapy Group; Sequential Combination Group; Whole-course Combination Group

Nucleoside Analogs DRUG

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

Initial Combination Group; NAs Monotherapy Group; Sequential Combination Group; Whole-course Combination Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 27239256 BACKGROUND

• 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.

  PMID: 28407271 BACKGROUND

• 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.

  PMID: 33896094 BACKGROUND

• 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.

  PMID: 23246508 BACKGROUND

• 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.

  PMID: 34350562 BACKGROUND

• 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.

  PMID: 32626791 BACKGROUND

• 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.

  PMID: 40390028 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2b; Nucleosides

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Zhiliang Gao, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

• Guizhou Zou

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Jiabin Li

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

• Zhende Lin

  Anxi County Hospital

  PRINCIPAL INVESTIGATOR

• Guoxin Hu

  SHENZHEN HOSPITAL of PEKING UNIVERSITY

  PRINCIPAL INVESTIGATOR

• Youping Lin

  Dongguan Binhai Bay Central Hospital

  PRINCIPAL INVESTIGATOR

• Sichun Yin

  Dongguan Ninth People's Hospital

  PRINCIPAL INVESTIGATOR

• Songmei He

  Dongguan People's Hospital

  PRINCIPAL INVESTIGATOR

• Zengjia Xu

  Dongyuan People's Hospital

  PRINCIPAL INVESTIGATOR

• Hui Shen

  DuShanZi People's Hospital

  PRINCIPAL INVESTIGATOR

• Haifei Luo

  First People's Hospital of Foshan

  PRINCIPAL INVESTIGATOR

• Wenhua Zhang

  Gansu Wuwei Tumor Hospital

  PRINCIPAL INVESTIGATOR

• Maosheng Wu

  Guangdong Second Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Dong Wei

  Guangzhou Second traditional Chinese Medicine hospital

  PRINCIPAL INVESTIGATOR

• Wenli Chen

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Bihua Gao

  Beihai People's hospital

  PRINCIPAL INVESTIGATOR

• Guifang Tang

  Nanxishan Hospital of Giang xi zhuang Autonomous Region

  PRINCIPAL INVESTIGATOR

• Huaiyu Song

  THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTCNOMOUS REGION

  PRINCIPAL INVESTIGATOR

• Zhuxiang Zhao

  The First Municipal Hospital of Guangzhou

  PRINCIPAL INVESTIGATOR

• Xihua Fu

  Guangzhou Panyu Central Hospital

  PRINCIPAL INVESTIGATOR

• Runqi Luo

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Shi Ouyang

  Fifth Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Chunlan Zhang

  GUANGZHOU EIGHTH PEOPLE'S HOSPITAL GUANGZHOU MEDICAL UNIVERSITY

  PRINCIPAL INVESTIGATOR

• Riying Lv

  Guigang city People's Hospital

  PRINCIPAL INVESTIGATOR

• Bigang Xiong

  GuiYang Public Health Clinlcal Center

  PRINCIPAL INVESTIGATOR

• Hong Peng

  the People's Hospital of Guizhou

  PRINCIPAL INVESTIGATOR

• Sufen Zhou

  The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Quan Zhang

  The Affiliated Hospital Of Guizhou Medical University

  PRINCIPAL INVESTIGATOR

• YongChao Xian

  The Third People's Hospital of Guilin

  PRINCIPAL INVESTIGATOR

• Ganwen Li

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

  PRINCIPAL INVESTIGATOR

• Jinyu Xia

  The Fifth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Bihui Zhong

  The First Afiliated Hospital Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Minhui Xiao

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

  PRINCIPAL INVESTIGATOR

• Wenjun Gao

  Zhongshan Sencond People's Hospital

  PRINCIPAL INVESTIGATOR

• Gang Li

  The fourth people's Hospital of Zibo

  PRINCIPAL INVESTIGATOR

• Yangwen Luo

  Zunyi Medical College

  PRINCIPAL INVESTIGATOR

• Jie Chen

  The Second People's Hospital OF YULIN

  PRINCIPAL INVESTIGATOR

• Xiaochao Qin

  Red Cross Hospital of Yulin City

  PRINCIPAL INVESTIGATOR

• Wuhai Qin

  teaditional chinese medicine hospital of YULIN

  PRINCIPAL INVESTIGATOR

• Hongshun Fan

  Yuebei Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Ming Jiang

  Guilin Municipal Hospital of Traditonal

  PRINCIPAL INVESTIGATOR

• Feng Lin

  HANNAN GENERAL HOSPITAL

  PRINCIPAL INVESTIGATOR

• Chengfang Zheng

  Hainan Western Central Hospital

  PRINCIPAL INVESTIGATOR

• Zhentao Gu

  Heyuan people's Hospital

  PRINCIPAL INVESTIGATOR

• Fan Li

  THE PEOPLE'S HOSPITAL of HEZHOU

  PRINCIPAL INVESTIGATOR

• Qin Yan

  Huazhong University of Science and Technology Union Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Zhanzhou Lin

  Huizhou Municipal Central Hospital

  PRINCIPAL INVESTIGATOR

• Hui Chen

  Hepatobiliary Hospital Of JiLin

  PRINCIPAL INVESTIGATOR

• Xujing Liang

  First Affiliated Hospital of Jinan University

  PRINCIPAL INVESTIGATOR

• Bin Liu

  The Affiliated Shunde Hospital of Jinan University

  PRINCIPAL INVESTIGATOR

• Changzheng Hu

  Jiangmen Central Hospital

  PRINCIPAL INVESTIGATOR

• Xingchuan Wang

  The 924th Hospital of the PLA joint Logistic support Force

  PRINCIPAL INVESTIGATOR

• Chengzu Lin

  Jinjiang City Hospital

  PRINCIPAL INVESTIGATOR

• Guihua Su

  the First People's Hopistal of Kashi

  PRINCIPAL INVESTIGATOR

• Yi Wang

  Karamay Central Hospital of Xinjiang

  PRINCIPAL INVESTIGATOR

• Yuqin Xu

  The 962th Hospital of the PLA joint Logistic support Force

  PRINCIPAL INVESTIGATOR

• Lingyi Zhang

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

• Xiaorong Mao

  LanZhou University

  PRINCIPAL INVESTIGATOR

• Hong Wan

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

• Qian Guo

  LIU ZHOU WORKER'S HOSPITAL

  PRINCIPAL INVESTIGATOR

• Liu He

  LIU ZHOU PEOPLE'S HOSPITAL

  PRINCIPAL INVESTIGATOR

• Zhengxiao Zhao

  LIU ZHOU TRADITIONAL CHINESE MEDICAL HOSPITAL

  PRINCIPAL INVESTIGATOR

• Yan Lincan

  Long yan hospital of traditional Chinese medicine

  PRINCIPAL INVESTIGATOR

• Feng Min

  army 73rd group military hospital

  PRINCIPAL INVESTIGATOR

• Xiqiu Zeng

  Mudanjiang Kangan Hospital

  PRINCIPAL INVESTIGATOR

• Shuilin Sun

  Second Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Xiaoping Wu

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

• Keqin Zhang

  The Ninth Hospital of Nanchang

  PRINCIPAL INVESTIGATOR

• Hong Li

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

• Jianzhen Yao

  Putian Hanjiang Hospital

  PRINCIPAL INVESTIGATOR

• Liqin Cai

  The First Hospital of Putian City

  PRINCIPAL INVESTIGATOR

• Rongxian Qiu

  The Affiliated Hospital of Putian University

  PRINCIPAL INVESTIGATOR

• Sandu Liu

  The People's Hospital Of QianNan

  PRINCIPAL INVESTIGATOR

• Qinghua Lu

  The Fourth People's Hospital of Qinghai Province

  PRINCIPAL INVESTIGATOR

• Ying Deng

  The Sixth Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Xingnan Pan

  Quanzhou Decheng hospital

  PRINCIPAL INVESTIGATOR

• Ruyi Guo

  Quanzhou First Hospital

  PRINCIPAL INVESTIGATOR

• Wenke Li

  Quanzhou Hospital of traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Huiwen Song

  SanMing First Hospital

  PRINCIPAL INVESTIGATOR

• Xiulan Xue

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Qianguo Mao

  Xiamen Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Haidong Zhao

  Xiamen Chang gung hospital

  PRINCIPAL INVESTIGATOR

• Yanhui Zu

  Shan dong public Health Clinical Center

  PRINCIPAL INVESTIGATOR

• Ruilie Chen

  Shantou Central Hospital

  PRINCIPAL INVESTIGATOR

• Shu Yang

  Shenzhen Bao'an People's Hospital

  PRINCIPAL INVESTIGATOR

• Jun Chen

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

• Yanyao Yin

  Shenzhen Luohu Hospitai of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Rongshan Fan

  Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine

  PRINCIPAL INVESTIGATOR

• Guangdong Tong

  SHEN ZHEN TRADITIONAL CHINESE MEDICINE HOSPITAL

  PRINCIPAL INVESTIGATOR

• Weize Zuo

  The First Affiliated Hospital of Shihezi University School of Medicine

  PRINCIPAL INVESTIGATOR

• Bin Zhou

  Weihai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Huanwei Zheng

  Shijiazhuang Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Chuantiao Zhang

  Shishi General Hospital

  PRINCIPAL INVESTIGATOR

• Qing Ye

  Tianjin Third Central Hospital

  PRINCIPAL INVESTIGATOR

• Xin Chen

  Tianjin First Hospital

  PRINCIPAL INVESTIGATOR

• Changxia Niu

  Tianshui First people's hospital

  PRINCIPAL INVESTIGATOR

• Jiancheng Zhang

  Tianshui traditional Chinese medicine hospital

  PRINCIPAL INVESTIGATOR

• Ruihai Zhu

  Weifang People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhushi Liang

  The Third People's Hospital of Wuzhou

  PRINCIPAL INVESTIGATOR

• Qingming Zheng

  Fujian Xianyou General Hospital

  PRINCIPAL INVESTIGATOR

• Xiaobo Lu

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

• Xiaozhong Wang

  Traditional Chinese Medicine Hospital of Xinjiang

  PRINCIPAL INVESTIGATOR

• Huanwen Chen

  XING AN COUNTY PEOPLE'S HOSPITSL

  PRINCIPAL INVESTIGATOR

• Haifeng Yu

  YANTAI QISHAN HOSPITAL

  PRINCIPAL INVESTIGATOR

• Shengtao Zeng

  Yili Prefecture Infectious Disease Hospital

  PRINCIPAL INVESTIGATOR

• Lei Li

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Weibing Shi

  The First Affiliated Hospital of Anhui University of Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Chuanmiao Liu

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Mei Cai

  Cangzhou Third Hospital

  PRINCIPAL INVESTIGATOR

• Lijuan Guan

  The 2nd Hospital of da qing City

  PRINCIPAL INVESTIGATOR

• Riwang Hu

  The 4th People's Hospital of da tong city

  PRINCIPAL INVESTIGATOR

• Jianli Huang

  Yongchun County Hospital

  PRINCIPAL INVESTIGATOR

• Yueyong Zhu

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

• Minghua Lin

  Mengchao Hepatobiliary Hospital of Hujian Medical University

  PRINCIPAL INVESTIGATOR

• Ming Li

  No.2 People's Hospital of Fuyang City

  PRINCIPAL INVESTIGATOR

• Xianqiu Huang

  Guidong People's Hospital of Guangxi Zhuang Autonomous Region

  PRINCIPAL INVESTIGATOR

• Liying Zhu

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Lei Yu

  The Fourth Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Baoshan Yang

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Yuguo Zhang

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Xiaoli Hu

  Heilongjiang provincial hospital

  PRINCIPAL INVESTIGATOR

• Weizhong Yan

  Jilin Central General Hospital

  PRINCIPAL INVESTIGATOR

• Xinsheng Xie

  Affiliated Hospital of Jiaxing University

  PRINCIPAL INVESTIGATOR

• Caihua Jiang

  FUJIAN JIANOU HOSPITAL

  PRINCIPAL INVESTIGATOR

• Guoqi Hu

  Jieshou City People's Hospital

  PRINCIPAL INVESTIGATOR

• Junmei Han

  THE THIRD HOSPITAL OF JIN CHENG

  PRINCIPAL INVESTIGATOR

• Deshun Yu

  JIN CHENG PEOPLE'S HOSPITAL

  PRINCIPAL INVESTIGATOR

• Jianqi Lian

  Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

• Jiuping Wang

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

• Zhengjun Xu

  The 910th Hospital

  PRINCIPAL INVESTIGATOR

• Fenxiang Li

  LIN FEN THIRD PEOPLE'S HOSPITAL

  PRINCIPAL INVESTIGATOR

• Tonghe Wu

  THE SECOND HOSPITAL OF LONGYAN

  PRINCIPAL INVESTIGATOR

• Fen Wu

  JIANYANG FIRST HOSPITAL OF NANPING

  PRINCIPAL INVESTIGATOR

• Yun Wu

  The Affiliated Hospital of Inner Mongolia Medical University

  PRINCIPAL INVESTIGATOR

• Houxiong Lin

  Ningde Municipal Hospital of Ningde Normal University

  PRINCIPAL INVESTIGATOR

• Yongyue Deng

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

• Xiao Wang

  Digestive Diseases Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

• Huaizhang Li

  Shanxi Traditional Chinese Medical Hospital

  PRINCIPAL INVESTIGATOR

• Liaoyun Zhang

  The First Affiliated Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

• Binhong Fu

  Shaowu Municiple Hospital of Fujian Province

  PRINCIPAL INVESTIGATOR

• Ye Gu

  The Sixth People's Hospital of Shenyang

  PRINCIPAL INVESTIGATOR

• Ying Guo

  The Third People's Hospital of Taiyuan

  PRINCIPAL INVESTIGATOR

• Ping Li

  Tianjin Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Zhifeng Li

  TONG LIAO INFECTIOUS DISEASES HOSPITAL

  PRINCIPAL INVESTIGATOR

• Jingning Zhao

  SINOPHARM TONGMEI GENERAL HOSPITAL

  PRINCIPAL INVESTIGATOR

• Shuangsuo Dang

  The Second Affiliated Hospital of Ｘi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Shumei Lin

  The First Affiliated Hospital of Ｘi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

• Hongxin Pu

  Yanbian University Hospital

  PRINCIPAL INVESTIGATOR

• Li Zhang

  The Sixth hospital of Handan City

  PRINCIPAL INVESTIGATOR

• Yongmei Lin

  Hanzhong 3201 Hospital

  PRINCIPAL INVESTIGATOR

• Chunzhi Su

  Hebei Hospital of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Mingxia Jiang

  Jiamusi Infectious Disease Hospital

  PRINCIPAL INVESTIGATOR

• Chengrun Xu

  Southeast Hospital affiliated to Xiamen University

  PRINCIPAL INVESTIGATOR

• Ying Dai

  The 7th Hospital of Qiqihar

  PRINCIPAL INVESTIGATOR

• Jiansheng Huang

  Wuping County Hospital

  PRINCIPAL INVESTIGATOR

• Qingrui Peng

  Xiapu County Hospital

  PRINCIPAL INVESTIGATOR

• Weixin Wang

  The 2nd Affiliated Hospital of YCU

  PRINCIPAL INVESTIGATOR

• Zhigang Lin

  SanMing Yongan General Hospital

  PRINCIPAL INVESTIGATOR

• Shihong Wu

  Yuncheng Central Hospital

  PRINCIPAL INVESTIGATOR

• Zhongfu Zhao

  Changzhi Medical College

  PRINCIPAL INVESTIGATOR

• Yi Zheng

  Xinhua Hospital of Zhejiang Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishuo Mo, Master

CONTACT

+86 13632434363; vbstone@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the infectious diseases department

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: January 10, 2022
• Study Start: January 8, 2022
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): November 30, 2029
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)