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

Primary Purpose

Hepatitis B, Chronic

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
lamivudine
Telbivudine
Enticavir
Adefovir Dipivoxil Tablets
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Chronic hepatitis B, antiviral treatment, long term prognosis

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Affiliated Hospital Of Sun Yat-sen UniversityRecruiting
  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

A

B

C

D

Arm Description

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

incidence rate of hepatic carcinoma
incidence rate of liver cirrhosis
incidence rate of fulminant hepatitis

Secondary Outcome Measures

Full Information

First Posted
December 1, 2008
Last Updated
December 17, 2008
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00810524
Brief Title
Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection
Official Title
Influence of Antiviral Treatment to the Long-Term Prognosis of Patients With Chronic HBV Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Chronic hepatitis B, antiviral treatment, long term prognosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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).
Arm Title
B
Arm Type
Active Comparator
Arm Description
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).
Arm Title
C
Arm Type
Experimental
Arm Description
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).
Arm Title
D
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
lamivudine
Intervention Description
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Intervention Description
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Intervention Type
Drug
Intervention Name(s)
Enticavir
Intervention Description
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
Intervention Type
Drug
Intervention Name(s)
Adefovir Dipivoxil Tablets
Intervention Description
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
Primary Outcome Measure Information:
Title
incidence rate of hepatic carcinoma
Time Frame
10 years after treatment
Title
incidence rate of liver cirrhosis
Time Frame
10 years after treatment
Title
incidence rate of fulminant hepatitis
Time Frame
10 years after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao zhiliang, M. D.
Phone
+862085252037
Email
zhanlianh@21cn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huang zhanlian, M. D.
Phone
+8685252046
Email
zhanlianh@21cn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao zhiliang, M. D.
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The Third Affiliated Hospital Of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao zhiliang, M. D.
Phone
+862085252037
Email
zhanlianh@21cm.com
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gao zhiliang, M. D.
Phone
+8685252037
First Name & Middle Initial & Last Name & Degree
gao zhiliang, doctor

12. IPD Sharing Statement

Learn more about this trial

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

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