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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00810524
• Other study ID #: SunYat-senU 5010 Hepatitis B
• Status: Recruiting
• Phase: Phase 4
• First received: December 1, 2008
• Last updated: December 17, 2008
• Start date: January 2007
• Est. completion date: January 2017

Study information

• Verified date: October 2008
• Source: Sun Yat-sen University
• Contact: Gao zhiliang, M. D.
• Phone: +862085252037
• Email: zhanlianh[@]21cn.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• lamivudine
100mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
• Telbivudine
600mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.
• Enticavir
0.5mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2 years.
• Adefovir Dipivoxil Tablets
10mg, P.O.,QD, duration: until HBeAg seroconversion for more than 2years.

Locations

Country	Name	City	State
China	The Third Affiliated Hospital Of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence rate of hepatic carcinoma		10 years after treatment	Yes
Primary	incidence rate of liver cirrhosis		10 years after treatment	Yes
Primary	incidence rate of fulminant hepatitis		10 years after treatment	Yes