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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00810524
Enrollment
600
Registered
2008-12-18
Start date
2007-01-31
Completion date
2017-01-31
Last updated
2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Chronic hepatitis B, antiviral treatment, long term prognosis

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.

Interventions

DRUGlamivudine

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

DRUGTelbivudine

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

DRUGEnticavir

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

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

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
incidence rate of hepatic carcinoma10 years after treatment
incidence rate of liver cirrhosis10 years after treatment
incidence rate of fulminant hepatitis10 years after treatment

Countries

China

Contacts

Primary ContactGao zhiliang, M. D.
zhanlianh@21cn.com+862085252037
Backup ContactHuang zhanlian, M. D.
zhanlianh@21cn.com+8685252046

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026