Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B
ConditionChronic Hepatitis b
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHuashan Hospital
About this trial
The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How do rates of HBsAg seroclearance, decompensated cirrhosis, liver fibrosis progression, and other virological and clinical outcomes compare across regimens? Researchers will compare real-world treatment arms-including nucleos(t)ide analogue (NA) monotherapy (e.g., entecavir, tenofovir), PegIFN based regimen (e.g., PegIFN monotherapy, PegIFN plus NA combinations)-to identify optimal strategies for reducing HCC risk and improving functional cure rates.
Participants will undergo routine clinical care with no study-imposed interventions; data on demographics, medical history, symptoms, laboratory tests (e.g., HBsAg, HBV DNA, liver function), imaging (e.g., ultrasound, elastography), and clinical events will be collected prospectively (for up to 5 years in some cohorts) or retrospectively from medical records at baseline and scheduled follow-up visits (e.g., every 3-12 months initially, then annually).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.
There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.
Planned or currently receiving potent low-resistance NAs [entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)], or planned to receive PegIFNα-2b, either treated or treatment-naïve.
Agree to participate in the study and sign the patient informed consent form.
Disqualifiers
Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline
Concurrently participating in other interventional clinical trials.
Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.
Trial population
patients with chronic hepatitis B under anti-viral treatment of peginterferon alpha based regimen or nucleos(t)ide alone.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
peginterferon alpha based regimen
Drugpeginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
nucleos(t)ide
Drugpeginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
Treatment groups
33,000 Participants
are divided into 3 treatment groupsGroup A: Prospective2 interventions
Group B: Retrospective-Prospective2 interventions
Group C: Retrospective2 interventions
Trial outcomes
Primary outcomes
1
rate of hepatocellular carcinoma at 5 year from baseline
Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 5 years from baseline
Time frame
5 year from baselineSecondary outcomes
1
rate of HBsAg loss
rate of HBsAg loss will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Time frame
24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline2
rate of decompensated cirrhosis
Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease event at 1year, 2 year, 3 year, 4 year, and 5 year from baseline
Time frame
1year, 2 year, 3 year, 4 year and 5 year from baseline3
rate of cirrhosis
rate of cirrhosis at 1 year, 2 year, 3 year, 4year, and 5 year from baseline
Time frame
1 year, 2 year, 3 year, 4year, and 5 year from baseline4
rate of fibrosis progression
rate of fibrosis progression will be measured as a histological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.
Time frame
24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baselineOther outcomes
1
demographic characteristics
demographic characteristics at baseline
Time frame
baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
Chinese Foundation for Hepatitis Prevention and Control
Collaborator
The Third People's Hospital of Taiyuan
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Beijing YouAn Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Yunnan Provincial No.1 Hospital
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
The First Affiliated Hospital of Xiamen University
Collaborator
Beijing Ditan Hospital
Collaborator
Tianjing No.2 People's Hospital
Collaborator
Qingdao No.6 People's Hospital
Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Collaborator
Ningbo Beilun District Traditional Chinese Medicine Hospital
Collaborator
Wuxi No.5 People's Hospital
Collaborator
Taicang No.1 People's hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
Source ClinicalTrials.gov