Chronic Hepatitis b
Conditions
Brief summary
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).
Detailed description
The OASIS study is a multicenter, observational, real-world cohort study designed to evaluate long-term outcomes of antiviral therapies for chronic hepatitis B (CHB). It compares nucleos(t)ide analogue (NA) monotherapy, pegylated interferon based regimen without randomization or blinding. Treatment decisions follow routine clinical guidelines, physician expertise, and patient-specific factors. The study includes three cohorts: Prospective (PS, 5-year follow-up post-consent), Retrospective-Prospective (RPS, retrospective from baseline ≥September 2020 to consent, then 5-year prospective), and Retrospective (RS, data from September 2020 to protocol implementation). The target of 33,000 patients was determined based on patient flow across sub-centers, ensuring sufficient power to detect differences in 5-year HCC incidence (primary endpoint) and secondary outcomes (e.g., HBsAg seroclearance rates).
Interventions
DRUGpeginterferon alpha based regimen
peginterferon 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
DRUGnucleos(t)ide
peginterferon 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
Sponsors
Chinese Foundation for Hepatitis Prevention and Control
The Third People's Hospital of Taiyuan
First Affiliated Hospital of Chongqing Medical University
Beijing YouAn Hospital
Henan Provincial People's Hospital
Yunnan Provincial No.1 Hospital
Third Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Xiamen University
Beijing Ditan Hospital
Tianjing No.2 People's Hospital
Qingdao No.6 People's Hospital
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Ningbo Beilun District Traditional Chinese Medicine Hospital
Wuxi No.5 People's Hospital
Taicang No.1 People's hospital
First Affiliated Hospital Xi'an Jiaotong University
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of hepatocellular carcinoma at 5 year from baseline | 5 year from baseline | Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 5 years from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of HBsAg loss | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline | 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. |
| rate of decompensated cirrhosis | 1year, 2 year, 3 year, 4 year and 5 year from baseline | 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 |
| rate of cirrhosis | 1 year, 2 year, 3 year, 4year, and 5 year from baseline | rate of cirrhosis at 1 year, 2 year, 3 year, 4year, and 5 year from baseline |
| rate of fibrosis progression | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline | 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. |
| rate of fibrosis regression | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline | rate of fibrosis regression 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. |
| HBsAg level | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline | HBsAg level will be measured at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively, and kinetics will be described based on the results. |
| rate of HBeAg loss | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline | rate of HBeAg 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. |
| rate of HBeAg conversion | 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline | rate of HBeAg conversion 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. |
| rate of HBV DNA undetectable | 1year, 2 year, 3 year, 4 year and 5 year from baseline | Rate of HBV DNA undetectable will be evaluated as an end-stage liver disease event at 1year, 2 year, 3 year, 4 year, and 5 year from baseline |
| rate of liver transplantation | 5 year from baseline | Rate of liver transplantation will be evaluated as an end-stage liver disease event at 5 year from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| demographic characteristics | baseline | demographic characteristics at baseline |
Countries
China
Contacts
Primary ContactWenhong Zhang, Professor
Backup ContactFeng Sun, doctor
Outcome results
None listed