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RECRUITINGOBSERVATIONAL

Real-world Study Optimizing Nucleotide-analogues

A Real-world Study of Optimizing Nucleotide-analogues-based Treatment for Chronic Hepatitis B

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this multicenter, observational, prospective study is to observe and compare different anti-viral treatment strategies in a real-world cohort of patients with CHB managed in routine clinical settings in China. The main questions it aims to answer are: 1. To evaluate the benefits of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who are recommended in the updated Chinese Guideline 2022, but not recommended in the Chinese Guideline 2019. 2. To evaluate the Chinese Guideline recommends initiation of treatment, but at least one foreign authoritative guideline (eg. AASLD, EASL) does not recommend the benefit of initiating first-line nucleos(t)ide analogue in patients with chronic HBV infection who initiate treatment. 3. To compare the treatment effect of different alternatives with patients who have partial response after treatment with first-line nucleos(t)ide analogues.

Who May Be Eligible (Plain English)

Who May Qualify: - CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months. - Age between 18-80 years. - Patient who reads and signs willing to sign a consent form. - Meet any conditions of the group listed below Group A-naïve and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline (observe-plan to treat or control-plan to follow-up) : A. HBV DNA positive, ALT is continuously upper limit of normal (male 30 U/L, female 19 U/L) B. HBeAg positive, HBV DNA≤2×10\^7 IU/ml; HBeAg negative, HBV DNA≥2×10\^3 IU/ml C. Meet any of the conditions listed below 1. Age\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis; 2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis; 3. TE indicates significant fibrosis, and ≤30 years, without family history of cirrhosis or HCC Group B-naïve and meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese Guidelines, but not in EASL or AASLD guideline (observe-plan to treat or control-plan to follow-up) : ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months. * Age between 18-80 years. * Patient who reads and signs informed consent. * Meet any conditions of the group listed below Group A-naïve and meeting the conditions that are recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline (observe-plan to treat or control-plan to follow-up) : A. HBV DNA positive, ALT is continuously upper limit of normal (male 30 U/L, female 19 U/L) B. HBeAg positive, HBV DNA≤2×10\^7 IU/ml; HBeAg negative, HBV DNA≥2×10\^3 IU/ml C. Meet any of the conditions listed below 1. Age\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis; 2. Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis; 3. TE indicates significant fibrosis, and ≤30 years, without family history of cirrhosis or HCC Group B-naïve and meeting the conditions that are recommended to initiate treatment in both 2019 and 2022 Chinese Guidelines, but not in EASL or AASLD guideline (observe-plan to treat or control-plan to follow-up) : A. Without cirrhosis, HBV DNA≤2000 IU/ml, ALT\>1 ULN; B. Without cirrhosis, HBV DNA\>2000 IU/ml, 1 ULN\<ALT≤2 ULN; C. Without cirrhosis, normal ALT, \>30 years, have a family history of cirrhosis or HCC, or TE indicates significant fibrosis; D. Without cirrhosis, HBV DNA 20-2000 IU/ml Group C-experienced and partial response (1. switch another first-line NA; 2. add-on another first-line NA; 3. switch another first-line NA and add-on peginterferon alpha; 4. continue the original plan) Treatment experienced patient who has received a first-line nucleos(t)ide analogue(NA) monotherapy for at least 48 weeks, i.e., entecavir, tenofovir disoproxil or tenofovir alafenamide, tenofovir amibufenamide, and has partial response. They plan to continue or change the therapy Exclusion Criteria: * Have poor compliance; * Received contraindicated concomitant drugs (subjects receiving prohibited drugs will need at least 30 days of washing out period) and known hypersensitivity reactions to the study drug, metabolites, or formulated excipients; * Any other clinical symptoms or previous treatment that the investigator considers that the individual subject is not suitable for this study or cannot comply with the administration requirements

Treatments Being Tested

DRUG

ETV/TAF/TDF/TMF/IFN

peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

DRUG

ETV/TAF/TDF/TMF

peginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study

Locations (20)

Anhui Provincial Hospital
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing YouAn Hospita
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
the Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
the First Hospital of Lanzhou University
Lanzhou, Gansu, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou, China
The Second Affiliated Hospital of Harbin Medical University
Ha’erbin, Ha'erbin, China
Hainan General Hospital
Haikou, Hainan, China
the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China