Chronic Hepatitis b
Conditions
Brief summary
This study is a multicenter, prospective, observational real-world study designed to investigate and analyze the current treatment patterns of chronic hepatitis B (CHB) across 200 hospitals in China. By comparing patient outcomes under different therapeutic regimens, it aims to provide high-quality evidence-based medical data to optimize CHB treatment strategies and follow-up protocols, ultimately contributing to the advancement of a functional cure for chronic hepatitis B.
Interventions
DRUGETV,TDF,TAF,TMF
treated with entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)
treated with Peginterferon α-2b injection
Sponsors
The First Affiliated Hospital of Zhengzhou University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Chronic HBV infection (HBsAg-positive for ≥6 months); 2.Age ≥18 years; 3.Patients who, based on real-world clinical practice needs, are planned or currently receiving treatment with:Entecavir (ETV),Tenofovir disoproxil fumarate (TDF),Tenofovir alafenamide fumarate (TAF),Tenofovir amibufenamide (TMF) OR Pegylated interferon α-2b-naïve patients OR Patients re-initiating pegylated interferon α-2b therapy; 4.Written informed consent obtained from the patient.
Exclusion criteria
* 1.Severe hepatic dysfunction or decompensated cirrhosis; 2.Concurrent participation in other clinical trials; 3.Hepatocellular carcinoma (HCC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with HBsAg-associated HCC post-therapy | Week 4-240 |
| Hepatocellular Carcinoma (HCC) Incidence | Week 4-240 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of decompensated cirrhosis | Week 4-240 |
| Incidence of decompensation-related complications | Week 4-240 |
| Liver transplantation incidence rate | Week 4-240 |
| Post-treatment relapse rate | Week 4-240 |
| Number of patients with HBsAg level decline from baseline | Week 4-240 |
| Liver fibrosis improvement rate | Week 4-240 |
| HBV DNA | Week 4-240 |
| Number of chronic hepatitis B (CHB) patients with accurate knowledge/awareness of HBV | Week 4-240 |
| Rate of HBsAg seroclearance | Week 4-240 |
| HBsAg seroconversion rate | Week 4-240 |
| Number of patients with altered HBsAg levels post-treatment | Week 4-240 |
| HBeAg seroconversion rate | Week 4-240 |
| Incidence of liver cirrhosis | Week 4-240 |
Countries
China
Contacts
Primary ContactHongxia Liang
Outcome results
None listed