Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

NCT ID: NCT03909191

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 454 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2020-05-01

Brief Summary

As an alternative biomarker of intrahepatic covalently closed circular DNA(cccDNA) transcriptional activity, hepatitis B virus(HBV)RNA may evolve during long-lasting virus-host interactionsduring chronic hepatitis B viral infection.The distribution pattern of serum HBV RNA levels in the natural course of chronic HBV infection remains unclear. Furthermore,serum HBV RNA was associated with response to NAs. So it may be another clinical surrogate marker for intrahepatic cccDNA level after long-term NAs treatment and be used to monitor NAs therapy. The aim of this study was to evaluate thelevels of HBV RNA during the natural courseof CHB and the role in distinguishingthe natural phases of HBV infection and to investigate whether serum HBV RNA level at the end of long-term NAs treatment had a similar or better predict effect on off-therapy relapse than serum HBsAg titer.

Conditions

Chronic HBV Infection; Drug Withdrawal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

treatment-naïve

treatment-naïve patients with chronic HBV infection

serum HBV RNA

Intervention Type: DIAGNOSTIC_TEST

serum HBV RNA level was determined by using HBV-SAT kit at different time point

NAs treated CHB patients

CHB patients undergoing long-term NAs treatment

serum HBV RNA

Intervention Type: DIAGNOSTIC_TEST

serum HBV RNA level was determined by using HBV-SAT kit at different time point

Interventions

serum HBV RNA

serum HBV RNA level was determined by using HBV-SAT kit at different time point

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 18 to 70 years old,
• no gender restriction,
• serum HBsAg positive than 6 months,
• can understand and sign informed consent,
• good compliance.

Exclusion Criteria

• coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc;
• coinfected with HIV,
• markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive,
• with hepatocellular carcinoma(HCC)
• with uncontrollable extrehepatic disease,
• received glucocorticoid or other immune inhibitor therapy,
• pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

LiangXS

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xuesong Liang, Dr

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Other Identifiers

HBV RNA2016

Identifier Type: -

Identifier Source: org_study_id