Serum HBV RNA Value on Chronic Hepatitis B Virus Infection Manage

Chronic HBV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03909191
• Other study ID #: HBV RNA2016
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: May 1, 2020

Study information

• Verified date: January 2021
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic HBV Infection
• Communicable Diseases
• Drug Withdrawal
• Hepatitis B
• Hepatitis B, Chronic
• Herpesviridae Infections
• Infection
• Substance Withdrawal Syndrome
• Virus Diseases

Intervention

Diagnostic Test:
• serum HBV RNA
serum HBV RNA level was determined by using HBV-SAT kit at different time point

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	serum HBV RNA in patients receiving long-term NAs therapy were tested at different time point	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	48 hrs after enrollment the serun HBV RNA level were tested
Secondary	Number of patients with evaluate HBV DNA relapse(> 20,000 IU/mL) through 96 weeks off-therapy	the cumulative viral relapse rates at the 1st and 2nd year off-therapy were calculated	viral rebound rates were calculated from stopping baseline to 24 month after drug cessation