Treatment and Prognosis of Patients With Chronic HBV Infection

NCT ID: NCT05392387

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-25

Study Completion Date

2026-10-25

Brief Summary

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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

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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.

Conditions

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Hepatitis B Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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peg-IFN-alpha alone

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

Standard antiviral therapy

Intervention Type OTHER

pegylated interferon or/and nucleos(t)ide analogues

nucleos(t)ide analogues alone

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

Standard antiviral therapy

Intervention Type OTHER

pegylated interferon or/and nucleos(t)ide analogues

combination

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

Standard antiviral therapy

Intervention Type OTHER

pegylated interferon or/and nucleos(t)ide analogues

Interventions

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Standard antiviral therapy

pegylated interferon or/and nucleos(t)ide analogues

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Yan Huang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Huang

Role: STUDY_DIRECTOR

Xiangya Hospital of Central South University

Locations

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Department of Infectious Disease, Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Huang

Role: CONTACT

+86 13874854142

Facility Contacts

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Yan Huang

Role: primary

+86 13874854142

Other Identifiers

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Xiangya HBV project

Identifier Type: -

Identifier Source: org_study_id

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