Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

Completed

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT01311947
• Lead Sponsor: China Medical University Hospital

Brief Summary

In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.

Detailed Description

Hepatitis B virus (HBV) infection is a serious worldwide health issue. Approximately 400 million people worldwide are chronic hepatitis B (CHB) patients. Currently, two therapeutic methods can be used to treat CHB. One is the nucleos(t)ide analogues, the other is the interferon alfa. Interferon alfa acts mainly by enhancing the immune system and directly inhibits the virus to a limited extent. It is known that mutations at preS, S, basal core promoter, precore and core gene are associated with an increased risk of HCC. However, it remains to be clarified as to the relation between HBV mutations and the therapeutic responses to interferon treatment. In order to clarify the association between HBV mutations appearing before and during interferon therapy and the therapeutic effects, serial serum samples from 100 HBeAg-positive CHB patients undergoing peginterferon alfa-2a therapy will be collected and analyzed for the mutations of preS/S gene and BCP-preC/C region, particularly for the deletion mutations. Furthermore, Real-Time PCR will be performed to measure the ratios of wild-type HBV and deletion mutant HBV before and at the end of peginterferon alfa-2a therapy. Finally, statistical analysis will be done to elucidate whether the mutations of preS/S gene and BCP-preC/C region have any relation with the therapeutic effect of peginterferon alfa-2a.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

HBeAg-positive chronic hepatitis B patients on Peginterferon therapy

Exclusion Criteria

HBeAg-negative chronic hepatitis B patients HBeAg-positive chronic hepatitis B patients on other kinds of therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic response to Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B	24 weeks after the end of 24 weeks of Peginterferon alfa-2a treatment

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan