Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection

December 17, 2008 updated by: Sun Yat-sen University

Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.

Influence of antiviral treatment to the long term prognosis of patients with chronic HBV infection. The aim of antiviral treatment for HBV is to reduce the long term severe complications. In this study, the investigators divided patients with chronic HBV infection into two groups, which start early antiviral treatment and conventional antiviral treatment respectively. All the patients will be followed for ten years. From this study, the investigators want to find out the optimal time for patients with chronic HBV infection to start antiviral treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The third affiliated hospital of Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Contact:
          • Gao zhiliang, M. D.
          • Phone Number: +8685252037
        • Principal Investigator:
          • gao zhiliang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBsAg positive for more than 6 months.
  • HBeAg positive.
  • HBV DNA over 10E5 copies/ml.

Exclusion Criteria:

  • Previous antiviral treatment for HBV.
  • Co infection of HIV, HCV, HEV, HAV, or HAV.
  • Evidence of hepatic carcinoma.
  • Evidence of autoimmune disease.
  • Evidence of thyroid disease.
  • History of mental sickness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
ACTIVE_COMPARATOR: B
120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
EXPERIMENTAL: C
180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
ACTIVE_COMPARATOR: D
180 subjects (have no family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).
Drug: lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Drug: Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Drug: Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence rate of hepatic carcinoma
Time Frame: 10 years after treatment
10 years after treatment
incidence rate of liver cirrhosis
Time Frame: 10 years after treatment
10 years after treatment
incidence rate of fulminant hepatitis
Time Frame: 10 years after treatment
10 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Gao zhiliang, M. D., Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ANTICIPATED)

January 1, 2017

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

December 1, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (ESTIMATE)

December 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SunYat-senU 5010 Hepatitis B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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