Status:
NOT_YET_RECRUITING
Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy
Lead Sponsor:
Wen-hong Zhang
Collaborating Sponsors:
Shandong Provincial Hospital
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
HBV
HCC
Eligibility:
All Genders
18-80 years
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 ...
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 cl...
Eligibility Criteria
Inclusion
- 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
- Patients with malignancies other than hepatocellular carcinoma.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT05965388
Start Date
December 1 2023
End Date
February 1 2029
Last Update
July 28 2023
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
3
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
4
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210000