Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

Not Applicable

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: interferon α plus nucleoside analogue; Drug: interferon α

• Registration Number: NCT00860626
• Lead Sponsor: Sun Yat-sen University

Brief Summary

For HBeAg(+) patients, interferon is used for 12 weeks. On 12th week of treatment, If HBV DNA is undetectable (\<1000 copies/ml), interferon is continued alone for one year. If HBV DNA is still positive, nucleoside analogue is added for 3 months. After nucleoside analogue is added for 3 months, HBV DNA is tested again. If negative, stop nucleoside analogue and use interferon alone for another 6 months or longer. If HBV DNA is still positive, change to another nucleoside analogue or add another nucleoside analogue.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Last Update Submitted: 2009-03-11
• Study First Posted: 2009-03-12
• Last Update Posted: 2009-03-12
• Primary Completion: 2009-12
• Study Completion: 2010-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• HBsAg posive for 6 months
• HBeAg positive, and HBeAb negative
• HBV DNA>1.0×E5 copies/ml
• ALT>80 u/L within 3 months

Exclusion Criteria

• pregnant women
• conbination infection of HCV, HAV, or HEV
• conbination infection of HIV
• any contraindication of interferon α

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	interferon α plus nucleoside analogue	At the twelfth week of interferon α treatment, HBV DNA is detectable(\>1000 copies/ml), or HBeAg is still positive. And nucleoside analogue is added for 12 weeks.
2	interferon α	At the twelfth week of interferon α treatment, HBV DNA is detectable (\>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.
3	interferon α	At the twelfth week of interferon α treatment, HBV DNA is undetectable (\<1000 copies/ml), or HBeAg is negative. And interferon is continued for another 9 months.

Primary Outcome Measures

Name	Time	Method
HBeAg seroconversion rate	3-6 months

Secondary Outcome Measures

Name	Time	Method
HBsAg loss rate	3-6 months
HBV DNA loss rate	3-6 months

Trial Locations

Locations (1)

The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guang zhou, Guang dong, China