Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B
NCT ID: NCT00860626
Last Updated: 2009-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2008-01-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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.
interferon α plus nucleoside analogue
Standard dose of interferon is used for 12 weeks. On 12th week of treatment, HBV DNA is still detectable (\>1000 copies/ml), or HBeAg is still positive. And lamivudine 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.
2
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.
interferon α
Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is still detectable (\>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.
3
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.
interferon α
Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is undetectable, or HBeAg is negative. And interferon is continued alone for another 9 months.
Interventions
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interferon α plus nucleoside analogue
Standard dose of interferon is used for 12 weeks. On 12th week of treatment, HBV DNA is still detectable (\>1000 copies/ml), or HBeAg is still positive. And lamivudine 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.
interferon α
Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is still detectable (\>1000 copies/ml), or HBeAg is still positive. But no nucleoside analogue is added.
interferon α
Standard dose of interferon is used for 12 weeks.On 12th week of treatment, HBV DNA is undetectable, or HBeAg is negative. And interferon is continued alone for another 9 months.
Eligibility Criteria
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Inclusion Criteria
* HBeAg positive, and HBeAb negative
* HBV DNA\>1.0×E5 copies/ml
* ALT\>80 u/L within 3 months
Exclusion Criteria
* conbination infection of HCV, HAV, or HEV
* conbination infection of HIV
* any contraindication of interferon α
18 Years
55 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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The Third Affliated Hospital of Sun Yat-sen University
Principal Investigators
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Gao zhiliang, Doctor
Role: STUDY_CHAIR
The Third Affliated Hospital of Sun Yat-sen University
Locations
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The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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huang zhanlian, doctor
Role: CONTACT
Facility Contacts
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Other Identifiers
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interferonshorttermnucleoside
Identifier Type: -
Identifier Source: org_study_id
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