Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

N

Naval Military Medical University

Status

Completed

Conditions

Chronic HBV Infection
Drug Withdrawal

Treatments

Diagnostic Test: serum HBV RNA

Study type

Observational

Funder types

Other

Identifiers

NCT03909191
HBV RNA2016

Details and patient eligibility

About

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.

Enrollment

454 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

454 participants in 2 patient groups

treatment-naïve
Description:
treatment-naïve patients with chronic HBV infection
Treatment:
Diagnostic Test: serum HBV RNA
NAs treated CHB patients
Description:
CHB patients undergoing long-term NAs treatment
Treatment:
Diagnostic Test: serum HBV RNA

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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