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

NCT01311947 | Completed DMC

• 1 other identifier: DMR99-IRB-313
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B, Chronic

Keywords

Chronic hepatitis B; Peginterferon alfa-2a

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Peginterferon alfa-2a DRUG

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

Also known as: Pegasys

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBeAg-positive chronic hepatitis B

You may qualify if:

• HBeAg-positive chronic hepatitis B patients on Peginterferon therapy

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan, 404, Taiwan

Location

Related Publications (1)

• Desmond CP, Bartholomeusz A, Gaudieri S, Revill PA, Lewin SR. A systematic review of T-cell epitopes in hepatitis B virus: identification, genotypic variation and relevance to antiviral therapeutics. Antivir Ther. 2008;13(2):161-75.

  PMID: 18505168 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum specimens

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheng-Yuan Peng, MD, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Hepatogastreoenterology

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

TW (1)