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

This study is currently recruiting participants.

Verified October 2008 by Sun Yat-sen University

Sponsor:

Information provided by:

Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT00810524

First received: December 1, 2008

Last updated: December 17, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

December 1, 2008

Last Updated Date

December 17, 2008

Start Date ^ICMJE

January 2007

Estimated Primary Completion Date

January 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

incidence rate of hepatic carcinoma [ Time Frame: 10 years after treatment ] [ Designated as safety issue: Yes ]
incidence rate of liver cirrhosis [ Time Frame: 10 years after treatment ] [ Designated as safety issue: Yes ]
incidence rate of fulminant hepatitis [ Time Frame: 10 years after treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00810524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis B, Chronic

Intervention ^ICMJE

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.

Study Arm (s)

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).
Interventions:
- Drug: lamivudine
- Drug: Telbivudine
- Drug: Enticavir
- Drug: Adefovir Dipivoxil Tablets
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).
Interventions:
- Drug: lamivudine
- Drug: Telbivudine
- Drug: Enticavir
- Drug: Adefovir Dipivoxil Tablets
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).
Interventions:
- Drug: lamivudine
- Drug: Telbivudine
- Drug: Enticavir
- Drug: Adefovir Dipivoxil Tablets
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).
Interventions:
- Drug: lamivudine
- Drug: Telbivudine
- Drug: Enticavir
- Drug: Adefovir Dipivoxil Tablets

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

January 2017

Estimated Primary Completion Date

January 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gao zhiliang, M. D.	+862085252037	zhanlianh@21cn.com
Contact: Huang zhanlian, M. D.	+8685252046	zhanlianh@21cn.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00810524

Other Study ID Numbers ^ICMJE

SunYat-senU 5010 Hepatitis B

Has Data Monitoring Committee

Yes

Responsible Party

The Third Affliated Hospital of Sun Yat-sen University

Study Sponsor ^ICMJE

Sun Yat-sen University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Gao zhiliang, M. D.

Third Affiliated Hospital, Sun Yat-Sen University

Information Provided By

Sun Yat-sen University

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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