Clinical trial NCT03909191: Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage
Official title: Serum HBV RNA Level Monitoring During Chronic Hepatitis B Virus Infection Especialy in Patients Undergoing Long-term Nucleos(t)Ide Analoguage Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic HBV Infection
Drug Withdrawal
Keywords: HBV RNA
HBsAg
cccDNA
Nucleos(t)ide analogue
virological relapse
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 454
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic Hepatitis B virus infection receiving or not receiving NAs treatment

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.


Eligibility criteria: 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.

Primary outcomes:
measure: serum HBV RNA value in treatment naive patients with chronic HBV infection were tested by using HBV SAT
timeFrame: serum HBV RNA level were measured 24hs after the enrollment
measure: End of treatment serum HBV RNA levels predict the 24-month off-therapy viral rebound
timeFrame: Change in serum HBV DNA levels from stopping baseline to 24 month after drug cessation was determined
Secondary outcomes:
measure: serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point
timeFrame: 48 hrs after enrollment the serun HBV RNA level were tested
measure: Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy
timeFrame: viral rebound rates were calculated from stopping baseline to 24 month after drug cessation
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Xuesong Liang, Dr
role: PRINCIPAL_INVESTIGATOR
References: