NCT03909191

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

4.2 years

First QC Date

April 1, 2019

Last Update Submit

January 30, 2021

Conditions

Chronic HBV InfectionDrug Withdrawal

Keywords

HBV RNAHBsAgcccDNANucleos(t)ide analoguevirological relapse

Outcome Measures

Primary Outcomes (2)

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

    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.

    serum HBV RNA level were measured 24hs after the enrollment

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

    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.

    Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

treatment-naïve

treatment-naïve patients with chronic HBV infection

Diagnostic Test: serum HBV RNA

NAs treated CHB patients

CHB patients undergoing long-term NAs treatment

Diagnostic Test: serum HBV RNA

Interventions

serum HBV RNADIAGNOSTIC_TEST

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

NAs treated CHB patientstreatment-naïve

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic Hepatitis B virus infection receiving or not receiving NAs treatment

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Xuesong Liang, Dr

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 9, 2019

Study Start

February 1, 2016

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share