Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03909191

Collaborator

(none)

454

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic HBV Infection Drug Withdrawal	Diagnostic Test: serum HBV RNA

Study Design

Study Type:

Observational

Actual Enrollment :

454 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
treatment-naïve treatment-naïve patients with chronic HBV infection	Diagnostic Test: serum HBV RNA 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	Diagnostic Test: serum HBV RNA serum HBV RNA level was determined by using HBV-SAT kit at different time point

Arm

Intervention/Treatment

treatment-naïve

treatment-naïve patients with chronic HBV infection

Diagnostic Test: serum HBV RNA

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

Diagnostic Test: serum HBV RNA

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.