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

C

China Medical University

Status

Completed

Conditions

Hepatitis B, Chronic

Treatments

Drug: Peginterferon alfa-2a

Study type

Observational

Funder types

Other

Identifiers

NCT01311947
DMR99-IRB-313

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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