Treatment and Prognosis of Patients With Chronic HBV Infection

Hepatitis B Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05392387
• Other study ID #: Xiangya HBV project
• Status: Recruiting
• Start date: October 25, 2021
• Est. completion date: October 25, 2026

Study information

• Verified date: May 2022
• Source: Xiangya Hospital of Central South University
• Contact: Yan Huang
• Phone: +86 13874854142
• Email: ganrankedrhyan[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: October 25, 2026
• Est. primary completion date: October 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis B
• Hepatitis B Virus Infection
• Herpesviridae Infections
• Infections
• Virus Diseases

Intervention

Other:
• Standard antiviral therapy
pegylated interferon or/and nucleos(t)ide analogues

Locations

Country	Name	City	State
China	Department of Infectious Disease, Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virological response	serum HBV DNA level below the detection limit	3 years
Primary	HBeAg seroconversion	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 years
Primary	Clinical cure	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	3 years
Secondary	HBV DNA	The serum HBV DNA level will be detected and reported every 3 to 6 months	3 years
Secondary	HBV serological test	HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months	3 years
Secondary	liver function	The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months	3 years
Secondary	Alpha-fetoprotein (AFP)	The serum AFP level will be detected and reported every 3 to 6 months	3 years