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

NCT ID: NCT00810524

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Hepatitis B, Chronic

Keywords

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Chronic hepatitis B antiviral treatment long term prognosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

lamivudine

Intervention Type DRUG

100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Telbivudine

Intervention Type DRUG

600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Enticavir

Intervention Type DRUG

0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.

Adefovir Dipivoxil Tablets

Intervention Type DRUG

10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

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).

Group Type ACTIVE_COMPARATOR

lamivudine

Intervention Type DRUG

100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Telbivudine

Intervention Type DRUG

600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Enticavir

Intervention Type DRUG

0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.

Adefovir Dipivoxil Tablets

Intervention Type DRUG

10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

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).

Group Type EXPERIMENTAL

lamivudine

Intervention Type DRUG

100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Telbivudine

Intervention Type DRUG

600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Enticavir

Intervention Type DRUG

0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.

Adefovir Dipivoxil Tablets

Intervention Type DRUG

10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

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).

Group Type ACTIVE_COMPARATOR

lamivudine

Intervention Type DRUG

100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Telbivudine

Intervention Type DRUG

600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Enticavir

Intervention Type DRUG

0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.

Adefovir Dipivoxil Tablets

Intervention Type DRUG

10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Interventions

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lamivudine

100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Intervention Type DRUG

Telbivudine

600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Intervention Type DRUG

Enticavir

0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.

Intervention Type DRUG

Adefovir Dipivoxil Tablets

10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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The Third Affliated Hospital of Sun Yat-sen University

Principal Investigators

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Gao zhiliang, M. D.

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

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The Third Affiliated Hospital Of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gao zhiliang, M. D.

Role: CONTACT

Phone: +862085252037

Email: [email protected]

Huang zhanlian, M. D.

Role: CONTACT

Phone: +8685252046

Email: [email protected]

Facility Contacts

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Gao zhiliang, M. D.

Role: primary

Gao zhiliang, M. D.

Role: primary

Other Identifiers

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SunYat-senU 5010 Hepatitis B

Identifier Type: -

Identifier Source: org_study_id