Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients

Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: Peginterferon Alfa-2B; Drug: Nucleoside Analogs

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhishuo Mo, Master; Phone Number: +86 13632434363; Email: vbstone@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
      • Sub-Investigator: Qi-Huan Xu, Professor
      • Contact: Zhi-Liang Gao, Professor; Phone Number: 86-20-85252373; Email: zhilianggao@21cn.com
      • Contact: Xiang Zhu, Doctor; Phone Number: 86-20-85252372; Email: 0628zhuxiang@163.com
      • Principal Investigator: Zhi-Liang Gao, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Peginterferon Alfa-2B; Different usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor.; Drug: Nucleoside Analogs; Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.
Experimental: 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.	Drug: Peginterferon Alfa-2B; Different usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor.; Drug: Nucleoside Analogs; Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.
Experimental: Whole-course Combination Group; NAs combined with peginterferon are used for a maximum course of 96 weeks. Follow-up period is 144 weeks.	Drug: Peginterferon Alfa-2B; Different usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor.; Drug: Nucleoside Analogs; Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.
Experimental: Peginterferon Monotherapy Group; Peginterferon is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.	Drug: Peginterferon Alfa-2B; Different usage of peginterferon Alfa-2B and/or Nucleos(t)ide analogs in arm/group descriptions are depended on the wishes of the patient and the advice of the attending doctor.
Experimental: NAs Monotherapy Group; NAs is used for a maximum course of 96 weeks. Follow-up period is 144 weeks.	Drug: Nucleoside Analogs; Nucleos(t)ide analogs refer to one of the first-line drugs, including ETV, TDF and TAF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBsAg serological conversion 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
The magnitude of HBsAg decline from baseline	HBsAg is detected by quantitative assays from Roche or Abbott	through treatment completion, an anticipated period of 96 weeks
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.	through treatment completion, an anticipated period of 96 weeks
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	through follow-up completion, an anticipated period of 144 weeks

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Chair: Zhiliang Gao, Doctor, Third Affiliated Hospital, Sun Yat-Sen 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: 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: 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: 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: Xiaorong Mao, LanZhou University; 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 4th 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: Weibing Shi, The First Affiliated Hospital of Anhui University of Chinese Medicine; 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: 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: 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: Binhong Fu, Shaowu Municiple Hospital of Fujian Province; Principal Investigator: Ying Guo, The Third People's Hospital of Taiyuan; 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: Guizhou Zou, The Second Hospital of Anhui Medical University; Principal Investigator: Wenhua Zhang, Gansu wuwei tumor hospital; Principal Investigator: Shi Ouyang, Fifth Affiliated Hospital of Guangzhou Medical University; Principal Investigator: Jinyu Xia, The Fifth Affiliated Hospital, Sun Yat-sen University; Principal Investigator: Lingyi Zhang, Lanzhou University Second Hospital; Principal Investigator: Hong Wan, Lanzhou University Second Hospital; Principal Investigator: Lei Li, Anhui Provincial Hospital; Principal Investigator: Chuanmiao Liu, The First Affiliated Hospital of Bengbu Medical University; Principal Investigator: Ming Li, NO.2 People's Hospital of Fuyang City; Principal Investigator: Xinsheng Xie, Affiliated Hospital of Jiaxing University; Principal Investigator: Liaoyun Zhang, The First Affiliated Hospital of Shanxi Medical University; Principal Investigator: Ye Gu, The Sixth People's Hospital of Shenyang; Principal Investigator: Ping Li, Tianjin Second People's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2022
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): November 30, 2029

Study Registration Dates

• First Submitted: December 18, 2021
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: functional cure; inactive chronic hepatitis B
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Hepatitis, Chronic; Anti-Infective Agents; Antiviral Agents; Peginterferon alfa-2b
• Other Study ID Numbers: [2021]02-373-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data would be available to other researchers with the approval of the ethics committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No