Real-world Study Optimizing Nucleotide-analogues
ConditionHepatitis B, Chronic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHuashan Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with chronic hepatitis B will receive the first-line antiviral therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ETV/TAF/TDF/TMF/IFN
Drugpeginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
ETV/TAF/TDF/TMF
Drugpeginterferon alpha or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
Treatment groups
20,000 Participants
are divided into 3 treatment groupsGroup A: Recommend to initiate treatment in 2022 Chinese Guideline, but not in 2019 Chinese Guideline1 intervention
Group B: Recommend to initiate treatment in 2019 and 2022 Chinese Guideline, but not in AASLD/EASL guidelines1 intervention
Group C: Treatment experienced and with partial response1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients with HBV DNA <20 IU/ml
The primary efficacy endpoint was the proportion of patients with HBV DNA \<20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR
Time frame
Week 482
The proportion of patients with HBV DNA <20 IU/ml
The primary efficacy endpoint was the proportion of patients with HBV DNA \<20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR
Time frame
Week 963
The proportion of patients with HBV DNA <20 IU/ml
The primary efficacy endpoint was the proportion of patients with HBV DNA \<20 IU/ml at each follow-up time point, as determined by high-sensitivity PCR
Time frame
Week 1444
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)
Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at each follow-up time point
Time frame
BaselineSecondary outcomes
1
Proportion of participants with Normal Alanine Aminotransferase (ALT)
Proportion of participants with Normal Alanine Aminotransferase (ALT) at each follow-up time point
Time frame
Week 48, Week 96 and Week 1442
Proportion of participants with Hepatitis B s Antigen (HBsAg) Loss
Proportion of participants with Hepatitis B s Antigen (HBsAg) Loss at each follow-up time point
Time frame
Week 48, Week 96 and Week 1443
Proportion of participants with Hepatitis B s Antigen (HBeAg) Loss
Proportion of participants with Hepatitis B s Antigen (HBeAg) Loss at each follow-up time point
Time frame
Week 48, Week 96 and Week 1444
Proportion of participants with seroconversion to Hepatitis B s Antigen (HBsAg)
Proportion of participants with seroconversion to Hepatitis B s Antigen (HBsAg) at each follow-up time point
Time frame
Week 48, Week 96 and Week 144Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
The First Affiliated Hospital of Anhui Medical University
Collaborator
Anhui Provincial Hospital
Collaborator
Beijing YouAn Hospital
Collaborator
Peking University People's Hospital
Collaborator
Peking University First Hospital
Collaborator
Xiamen Hospital of Traditional Chinese Medicine
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
LanZhou University
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
The Affiliated Hospital Of Guizhou Medical University
Collaborator
Hainan General Hospital
Collaborator
Hebei Medical University Third Hospital
Collaborator
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
Henan Provincial People's Hospital
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Tongji Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Central South University
Collaborator
Xiangya Hospital of Central South University
Collaborator
The First Hospital of Jilin University
Collaborator
the Second Hospital of Nangjing
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
The First Affiliated Hospital of Nanchang University
Collaborator
Shengjing Hospital
Collaborator
Qingdao Sixth People's Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
The First Affiliated Hospital of Shanxi Medical University
Collaborator
Tang-Du Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Ruijin Hospital
Collaborator
West China Hospital
Collaborator
Tianjin Second People's Hospital
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
The First People's Hospital of Yunnan
Collaborator
Shulan (Hangzhou) Hospital
Collaborator
Zhejiang University
Collaborator
Southwest Hospital, China
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov