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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00860626 |
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.
Condition | Intervention |
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Hepatitis B, Chronic |
Drug: interferon α plus nucleoside analogue Drug: interferon α |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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.
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Drug: 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.
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2: Active Comparator
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.
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Drug: 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: Active Comparator
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.
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Drug: 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.
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: huang zhanlian, doctor | +86013580584031 |
China, Guang dong | |
The Third Affliated Hospital of Sun Yat-sen University | Recruiting |
Guang zhou, Guang dong, China, 510000 | |
Contact: huang zhanlian, Doctor +86013580584031 zhanlianh@21cn.com |
Study Chair: | Gao zhiliang, Doctor | The Third Affliated Hospital of Sun Yat-sen University |
Responsible Party: | The Third Affliated Hospital of Sun Yat-sen University ( The Third Affliated Hospital of Sun Yat-sen University ) |
Study ID Numbers: | interferonshorttermnucleoside |
Study First Received: | March 11, 2009 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00860626 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic Hepatitis B, Chronic |
Interferons Hepatitis B Lamivudine Hepatitis, Viral, Human DNA Virus Infections Antiviral Agents |
Anti-Infective Agents Liver Diseases Hepatitis, Chronic Antineoplastic Agents Interferons Hepatitis, Viral, Human Antiviral Agents Hepadnaviridae Infections |
Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Hepatitis B, Chronic Therapeutic Uses Hepatitis B DNA Virus Infections |