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

Sponsored by:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00860626

Purpose

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
Hepatitis B, Chronic	Drug: interferon α plus nucleoside analogue Drug: interferon α

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Interferons

U.S. FDA Resources

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

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

HBeAg seroconversion rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HBV DNA loss rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
HBsAg loss rate [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

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.	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.
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.	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.	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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860626

Contacts

Contact: huang zhanlian, doctor

+86013580584031

Locations

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

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Study Chair:

Gao zhiliang, Doctor

The Third Affliated Hospital of Sun Yat-sen University

More Information

No publications provided

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009