Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy

NCT05965388 · tracked via the Priya Life Science China tracker

Sponsor

Wen-hong Zhang

Phase

Observational

Started

2023-12-01

Last updated

2023-07-28

Condition(s) studied

HBVHCC

Investigational drug(s) / intervention(s)

nucleoside analogues or interferon

nucleoside analogues or interferon: ETV、TDF、TAF、TAF、IFN-a-2b

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period — 5 years
Number of Participants with Diagnosis of hepatocellular carcinoma

Trial sites (10)

Facility	City	Region
The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
Jiangsu Province Hospital	Nanjing	Jiangsu
the Affiliated Hosptial of Xuzhou Medical University	Xuzhou	Jiangsu
Shandong Provincial Hospital of Shandong University	Jinan	Shandong
The Third People's Hospital of Taiyuan	Taiyuan	Shanxi
First Affiliated Hospital Xi'an Jiaotong University	Xi’an	Shanxi
The First People's Hospital Of YunNan	Kunming	Yunnan
Huashan Hospital	Shanghai	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05965388 on ClinicalTrials.gov ↗ ← All trials in China