Treatment and Prognosis of Patients With Chronic HBV Infection

NCT05392387 | Recruiting

• 1 other identifier: Xiangya HBV project
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis B Virus Infection

Keywords

Hepatitis B Virus Infection; antiviral therapy; prognosis

Outcome Measures

Primary Outcomes (3)

• virological response

  serum HBV DNA level below the detection limit

  3 years

• 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

• 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 Outcomes (4)

• HBV DNA

  3 years

• HBV serological test

  3 years

• liver function

  3 years

• Alpha-fetoprotein (AFP)

  3 years

Study Arms (3)

peg-IFN-alpha alone

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

Other: Standard antiviral therapy

nucleos(t)ide analogues alone

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

Other: Standard antiviral therapy

combination

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

Other: Standard antiviral therapy

Interventions

Standard antiviral therapy OTHER

pegylated interferon or/and nucleos(t)ide analogues

combination; nucleos(t)ide analogues alone; peg-IFN-alpha alone

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The chronic HBV-infected patients with differential antiviral strategies were recruited and separated to peg-IFN-alpha alone, NAs alone or combination treatment groups according to their antiviral therapies. The clinical outcomes of patients with differential treatments were compared during the follow-up management.

You may qualify if:

• patients with evidence of chronic HBV infection

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Department of Infectious Disease, Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood including blood cells, serum and plasma, urine, faeces and liver tissue

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Officials

• Yan Huang

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

Central Study Contacts

Yan Huang

CONTACT

+86 13874854142; ganrankedrhyan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: October 25, 2021
• Primary Completion: October 25, 2024
• Study Completion (Estimated): October 25, 2026
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

CN (1)