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Completed

NCT Number: NCT03909191

Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

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.

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Key information

Conditions

Chronic HBV Infection Chemically-Induced Disorders Drug Withdrawal Mental Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serum HBV RNA

Diagnostic Test

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

Primary outcomes

  1. serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT

    Time frame: 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.

  2. End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound

    Time frame: 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 outcomes

  1. serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point

    Time frame: 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

  2. Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Serum HBV RNA Level Monitoring During Chronic Hepatitis B Virus Infection Especialy in Patients Undergoing Long-term Nucleos(t)Ide Analoguage Treatment

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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