Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05392387

Treatment and Prognosis of Patients With Chronic HBV Infection

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hepatitis B Virus Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Infectious Disease, Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location status: Recruiting

Location contact

Yan Huang

CONTACT

[email protected]

+86 13874854142

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard antiviral therapy

Other

pegylated interferon or/and nucleos(t)ide analogues

Primary outcomes

  1. virological response

    Time frame: 3 years

    serum HBV DNA level below the detection limit

  2. HBeAg seroconversion

    Time frame: 3 years

    Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative

  3. Clinical cure

    Time frame: 3 years

    Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver

Secondary outcomes

  1. HBV DNA

    Time frame: 3 years

    The serum HBV DNA level will be detected and reported every 3 to 6 months

  2. HBV serological test

    Time frame: 3 years

    HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months

  3. liver function

    Time frame: 3 years

    The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months

  4. Alpha-fetoprotein (AFP)

    Time frame: 3 years

    The serum AFP level will be detected and reported every 3 to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Huang

CONTACT

[email protected]

+86 13874854142

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study title

Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
May 26, 2022
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.