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NCT Number: NCT01311947

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alfa-2a

Drug

Peginterferon alfa-2a at 180 ug weekly for 24 weeks

Other names: Pegasys

Primary outcomes

  1. Therapeutic response to Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

    Time frame: 24 weeks after the end of 24 weeks of Peginterferon alfa-2a treatment

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 10, 2011
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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