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

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

⁃ Age\>30 years, and have a family history of cirrhosis or HCC, TE indicates no significant fibrosis;

⁃ Family history of cirrhosis or HCC, and ≤30 years, TE indicates no significant fibrosis;

⁃ 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

Locations
Other Locations
China
Beijing YouAn Hospita
NOT_YET_RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Peking University People's Hospital
NOT_YET_RECRUITING
Beijing
the First Bethune Hospital Of Jilin University
NOT_YET_RECRUITING
Changchun
the Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
the Southwest Hospital of AMU
NOT_YET_RECRUITING
Chongqing
First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
The Affiliated Hospital Of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
The Second Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Ha’erbin
Hainan General Hospital
NOT_YET_RECRUITING
Haikou
Shulan (Hangzhou) Hospital
NOT_YET_RECRUITING
Hangzhou
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Shandong Provincial Hospital Affiliated to Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The Second Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
First People's Hospital of Yunnan Province
NOT_YET_RECRUITING
Kunming
the First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
Third Affiliated Hospital, Sun Yat-Sen University
NOT_YET_RECRUITING
Meizhou
the First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NOT_YET_RECRUITING
Nanjing
the Second Hospital of Nangjing
NOT_YET_RECRUITING
Nanjing
First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Nanning
No. 6 People's Hospital of Qingdao
NOT_YET_RECRUITING
Qingdao
Huashan Hospital
RECRUITING
Shanghai
Ruijin Hospital
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
the Third Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Tianjin Second People's Hospital
NOT_YET_RECRUITING
Tianjin
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Ürümqi
Renmin Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Tongji Hospital
NOT_YET_RECRUITING
Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Tangdu Hospital, The Fourth Military Medical University
NOT_YET_RECRUITING
Xi'an
the First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Xiamen Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Xiamen
the Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Wenghong Zhang, MD
zhangwenhong@fudan.edu.cn
13801844344
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2029-01-31
Participants
Target number of participants: 20000
Treatments
Recommend to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline
Untreated population who does not be recommended to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline. The initate treatment is to receive a first-line nucleos(t)ide analogue, i.e., entecavir, tenofovir disoproxil, or tenofovir alafenamide, tenofovir amibufenamide
Recommend to initiate treatment in 2019 and 2022 Chinese Guideline, but not in AASLD/EASL guidelines
Untreated population will receive a first-line nucleos(t)ide analogue , i.e., entecavir, tenofovir disoproxil, or tenofovir alafenamide, tenofovir amibufenamide, and the population should meet the conditions that are recommended to initiate treatment in 2019 and 2022 Chinese guideline, but not in AASLD/EASL guidelines
Treatment experienced and with partial response
Treatment experienced population who has received a first-line nucleos(t)ide analogue(NA) as monotherapy at least 48 weeks, i.e., entecavir, tenofovir disoproxil, or tenofovir alafenamide, tenofovir amibufenamide, and has partial response to NA. They will continue the original therpay or plans to change the therapy (e.g. switch another first-line NA, add-on another first-line NA, switch another first-line NA and add-on peginterferon alpha)
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Anhui Provincial Hospital, Hebei Medical University Third Hospital, Hainan General Hospital, West China Hospital, Peking University First Hospital, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Fujian Medical University, Xiangya Hospital of Central South University, Shengjing Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Xinjiang Medical University, Tang-Du Hospital, Tongji Hospital, Southwest Hospital, China, The First Hospital of Jilin University, Renmin Hospital of Wuhan University, Shulan (Hangzhou) Hospital, Shandong Provincial Hospital, Xiamen Hospital of Traditional Chinese Medicine, The Second Hospital of Shandong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Central South University, The Affiliated Hospital of Xuzhou Medical University, the Second Hospital of Nangjing, Sichuan Provincial People's Hospital, Ruijin Hospital, The First Affiliated Hospital of Nanchang University, First Affiliated Hospital Xi'an Jiaotong University, The Second Affiliated Hospital of Harbin Medical University, The First Affiliated Hospital with Nanjing Medical University, Beijing YouAn Hospital, The Affiliated Hospital Of Guizhou Medical University, The Second Affiliated Hospital of Chongqing Medical University, Peking University People's Hospital, Tianjin Second People's Hospital, Qingdao Sixth People's Hospital, Henan Provincial People's Hospital, Zhejiang University, LanZhou University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Shanxi Medical University, The First People's Hospital of Yunnan, First Affiliated Hospital of Guangxi Medical University
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov