Treatment and Prognosis of Patients With Chronic HBV Infection

Central South University

Status: Enrolling

Conditions: Hepatitis B Virus Infection

Treatments: Other: Standard antiviral therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05392387

Xiangya HBV project

Details and patient eligibility

About

Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.

Full description

Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

patients with evidence of chronic HBV infection

Exclusion criteria

chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.

Trial design

500 participants in 3 patient groups

peg-IFN-alpha alone

Description:

Patients with chronic HBV infection only treated with peg-IFN-alpha

Treatment:

Other: Standard antiviral therapy

nucleos(t)ide analogues alone

Description:

Patients with chronic HBV infection only treated with nucleos(t)ide analogues

Treatment:

Other: Standard antiviral therapy

combination

Description:

Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha

Treatment:

Other: Standard antiviral therapy