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NCT05937178

Real-world Study Optimizing Nucleotide-analogues

Sponsor: Huashan Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

20000

Start Date

2023-01-31

Completion Date

2029-01-31

Last Updated

2023-07-10

Healthy Volunteers

Conditions

Hepatitis B, Chronic

Interventions

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

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

Locations (44)

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

the Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

the Second Hospital of Nangjing

Nanjing, Jiangsu, China

the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

the First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

the First Bethune Hospital Of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Tangdu Hospital, The Fourth Military Medical University

Xi'an, Shaanxi, China

the First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

The Second Hospital of Shandong University

Jinan, Shandong, China

No. 6 People's Hospital of Qingdao

Qingdao, Shandong, China

Ruijin Hospital

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Third Affiliated Hospital, Sun Yat-Sen University

Meizhou, Xiamen, China

Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

Ürümqi, Xinjiang Uygur Autonomous Region, China

First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, China

Huashan Hospital

Shanghai, China

Clinical Research Directory

Real-world Study Optimizing Nucleotide-analogues

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (44)