Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection
1 other identifier
interventional
600
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2007
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedDecember 18, 2008
October 1, 2008
10 years
December 1, 2008
December 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
incidence rate of hepatic carcinoma
10 years after treatment
incidence rate of liver cirrhosis
10 years after treatment
incidence rate of fulminant hepatitis
10 years after treatment
Study Arms (4)
A
EXPERIMENTAL120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is lower than 80u/L (early antiviral treatment).
B
ACTIVE COMPARATOR120 subjects (have family history of hepatic carcinoma or liver cirrhosis). Antiviral treatment are started when ALT is higher than 80u/L (regular antiviral treatment).
C
EXPERIMENTAL180 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).
D
ACTIVE COMPARATOR180 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
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Eligibility Criteria
You may qualify if:
- HBsAg positive for more than 6 months.
- HBeAg positive.
- HBV DNA over 10E5 copies/ml.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China
Unknown Facility
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gao zhiliang, M. D.
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 18, 2008
Study Start
January 1, 2007
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
December 18, 2008
Record last verified: 2008-10