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Serum Hepatitis B Surface Antigen Levels to Guide the Stopping of Entecavir in HBeAg-negative Chronic Hepatitis B

NCT02069678 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2014-02-24

No results posted yet for this study

Summary

This will be a multi-center study in Hong Kong. This is a retrospective-prospective study in HBeAg-negative chronic hepatitis B patients. HBeAg-negative patients on entecavir followed up in the liver clinics will be identified from the existing database. All patients had HBV DNA testing every 6 months as a clinic routine. Serum HBsAg levels will be tested in the residual serum samples at the pre-treatment and last follow-up visits. Eligible patients will be discussed on the plan of stopping entecavir therapy. All patients will have written informed consent before recruited into this study. All patients will be followed up for 12 months after stopping entecavir treatment. As entecavir is most commonly used antiviral drug in Hong Kong and in the Western countries, the investigators aim to investigate and validate the use of serum HBsAg quantification to guide the timing of stopping entecavir in HBeAg-negative patients. The results of this study will provide scientific evidence on the use of this new serum marker to predict sustained remission after stopping entecavir. In the long-run, it can improve patient compliance, reduce the need of long-term antiviral and reduce the drug cost in the management of HBeAg-negative chronic hepatitis B.

All patients will stop entecavir according to the Asian Pacific guideline with written informed consent and close subsequent monitoring. In the protocol, there is a safety net for re-treatment. There will not be any invasive procedure. There is no major ethical issue.

Conditions

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069678 on ClinicalTrials.gov