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

December 1, 2008
December 17, 2008
January 2007
January 2017   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00810524 on ClinicalTrials.gov Archive Site
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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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B, Chronic
  • 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: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
January 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
20 Years to 45 Years
No
Contact: Gao zhiliang, M. D. +862085252037 zhanlianh@21cn.com
Contact: Huang zhanlian, M. D. +8685252046 zhanlianh@21cn.com
China
 
NCT00810524
SunYat-senU 5010 Hepatitis B
Yes
The Third Affliated Hospital of Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Director: Gao zhiliang, M. D. Third Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
October 2008

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