HBV, HCC
Conditions
Brief summary
The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B. Participants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.
Detailed description
This study is a prospective, exploratory, multi-center, real-world study, with Huashan Hospital as the leading unit. The study includes patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment { including pegylated interferon \[IFN\] monotherapy, a potent nucleos(t)ide analogue \[NA\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy. The study only collects clinical data and serum samples, without imposing any additional intervention measures or affecting any relevant clinical decisions. The clinical data is collected from the patient's clinical follow-up examination data, without additional visits and auxiliary examinations. Sample collection During the necessary clinical examination and blood draw during the patient's treatment and follow-up, one additional serum separation tube (3ml) was drawn, without additional invasive examination for the patient. The study will follow up with patients for 5 years to explore the relationship between the serum HBV pgRNA level and the endpoint event at different time points.
Interventions
DRUGnucleoside analogues or interferon
ETV、TDF、TAF、TAF、IFN-a-2b
Sponsors
Shandong Provincial Hospital
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Fujian Medical University
The Third People's Hospital of Taiyuan
The First People's Hospital of Yunnan
The First Affiliated Hospital of Anhui Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The First Affiliated Hospital with Nanjing Medical University
Wen-hong Zhang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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, gender is not limited； * Patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment {including pegylated interferon \[IFN\] monotherapy, a potent nucleos(t)ide analogue \[NA\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy; * Patient who reads and signs informed consent.
Exclusion criteria
* Patients with malignancies other than hepatocellular carcinoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period | 5 years | Number of Participants with Diagnosis of hepatocellular carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period | Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240 | Number of Participants with Diagnosis of participants with decompensation cirrhosis |
| Number of Participants with Diagnosis of participants with liver transplantation during the observation period | Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240 | Number of Participants with Diagnosis of participants with liver transplantation |
| Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period | Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240 | Number of Participants with Diagnosis of participants with fibrosis regression and progression |
| Number of Participants with Diagnosis of participants with serological response during the observation period | Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240 | Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg |
Countries
China
Contacts
Primary ContactWenhong Zhang, MD
Outcome results
None listed