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

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ClinicalTrials.gov Identifier: NCT01311947
Recruitment Status : Completed
First Posted : March 10, 2011
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Hepatitis B, Chronic Drug: 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 Design

Study Type : Observational
Actual Enrollment : 103 participants
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
Study Start Date : March 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Drug: Peginterferon alfa-2a
    Peginterferon alfa-2a at 180 ug weekly for 24 weeks
    Other Name: Pegasys

Outcome Measures

Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Serum specimens

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Immunologic Factors
Physiological Effects of Drugs