Treatment and Prognosis of Patients With Chronic HBV Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard antiviral therapy.
- Who it may be relevant to
- Registry conditions: Hepatitis B Virus Infection. Basic parameters: 18 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection
Overview
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.
Detailed 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.
Interventions
- Other Standard antiviral therapy
pegylated interferon or/and nucleos(t)ide analogues
Primary outcome measures
- virological response [Time frame: 3 years]
- HBeAg seroconversion [Time frame: 3 years]
- Clinical cure [Time frame: 3 years]
Secondary outcome measures (4)
- HBV DNA [Time frame: 3 years]
- HBV serological test [Time frame: 3 years]
- liver function [Time frame: 3 years]
- Alpha-fetoprotein (AFP) [Time frame: 3 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of Infectious Disease, Xiangya Hospital, Central South University — Changsha
Identifiers
NCT: NCT05392387 · Xiangya HBV project