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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheng-Yuan Peng, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01311947
First received: March 8, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Hepatitis B, Chronic
Drug: Peginterferon alfa-2a

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relation of Hepatitis B Virus Mutants and the Therapeutic Effect of Peginterferon Alfa-2a in HBeAg-Positive Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum specimens


Enrollment: 103
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Peginterferon alfa-2a
    Peginterferon alfa-2a at 180 ug weekly for 24 weeks
    Other Name: Pegasys
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HBeAg-positive chronic hepatitis B

Criteria

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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01311947

Locations
Taiwan
China Medical University Hospital
Taichung, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Cheng-Yuan Peng, MD, PhD China Medical University Hospital
  More Information

Publications:
Responsible Party: Cheng-Yuan Peng, Director of Division of Hepatogastreoenterology, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01311947     History of Changes
Other Study ID Numbers: DMR99-IRB-313
Study First Received: March 8, 2011
Last Updated: July 29, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Chronic hepatitis B
Peginterferon alfa-2a

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014