Treatment and Prognosis of Patients With Chronic HBV Infection

• Sponsor: Xiangya Hospital of Central South University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05392387
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Virus Infection	Other: Standard antiviral therapy

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection
• Actual Study Start Date: Oct 25, 2021
• Anticipated Primary Completion Date: Oct 25, 2024
• Anticipated Study Completion Date: Oct 25, 2026

Arms and Interventions

Arm	Intervention/Treatment
peg-IFN-alpha alone Patients with chronic HBV infection only treated with peg-IFN-alpha	Other: Standard antiviral therapy; 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	Other: Standard antiviral therapy; pegylated interferon or/and nucleos(t)ide analogues
combination Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha	Other: Standard antiviral therapy; pegylated interferon or/and nucleos(t)ide analogues

Outcome Measures

Primary Outcome Measures

1. virological response [3 years]

   serum HBV DNA level below the detection limit

2. HBeAg seroconversion [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 [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 Outcome Measures

1. HBV DNA [3 years]

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

2. HBV serological test [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 [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) [3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Infectious Disease, Xiangya Hospital, Central South University	Changsha	Hunan	China	410008

Sponsors and Collaborators

• Xiangya Hospital of Central South University

Investigators

• Study Director: Yan Huang, Xiangya Hospital of Central South University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yan Huang, MD, Professor, Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT05392387
• Other Study ID Numbers: Xiangya HBV project
• First Posted: May 26, 2022
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yan Huang, MD, Professor, Xiangya Hospital of Central South University: Hepatitis B Virus Infection; antiviral therapy; prognosis
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis B; Virus Diseases; Herpesviridae Infections; Hepatitis; Antiviral Agents

Study Results

No Results Posted as of May 26, 2022