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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: lamivudine
Drug: Telbivudine
Drug: Enticavir
Drug: Adefovir Dipivoxil Tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: January 2007
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810524

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

Locations
China, Guangdong
Recruiting
Guangzhou, Guangdong, China
Contact: Gao zhiliang, M. D.    +8685252037      
Principal Investigator: gao zhiliang, doctor         
The Third Affiliated Hospital Of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Gao zhiliang, M. D.    +862085252037    zhanlianh@21cm.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Gao zhiliang, M. D. Third Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: The Third Affliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00810524     History of Changes
Other Study ID Numbers: SunYat-senU 5010 Hepatitis B
Study First Received: December 1, 2008
Last Updated: December 17, 2008
Health Authority: United States: Institutional Review Board
China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Chronic hepatitis B
antiviral treatment
long term prognosis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Adefovir
Adefovir dipivoxil
Lamivudine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 29, 2014