Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

Completed

• Conditions: Drug Withdrawal; Chronic HBV Infection
• Interventions: Diagnostic Test: serum HBV RNA

• Registration Number: NCT03909191
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2019-04-01
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-09
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-30
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treatment-naïve	serum HBV RNA	treatment-naïve patients with chronic HBV infection
NAs treated CHB patients	serum HBV RNA	CHB patients undergoing long-term NAs treatment

Primary Outcome Measures

Name	Time	Method
serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT	serum HBV RNA level were measured 24hs after the enrollment	serum HBV RNA level in patients with chronic HBV infection during different natural history stage were were compared. The relationship between serum HBV RNA and other viral markers,such as HBV DNA,HBeAg and HBsAg, were determined.
End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound	Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined	End of treatment serum HBV RNA in patients after long-term nucleos(t)ide analog therapy were tested and the predictive effect of EOT HBV RNA value on 24-month off-therapy viral rebound were determined.

Secondary Outcome Measures

Name	Time	Method
serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point	48 hrs after enrollment the serun HBV RNA level were tested	serum HBV RNA change pattern along long-term NAs therapy wad determined and the relationship between HBV RNA and HBV DNA or HBsAg during NAs therapy were also determined
Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy	viral rebound rates were calculated from stopping baseline to 24 month after drug cessation	the cumulative viral relapse rates at the 1st and 2nd year off-therapy were calculated