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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00860626
First received: March 11, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Response to Interferon Combined Short-Term Nucleoside Analogue Therapy in HBeAg(+) Chronic Hepatitis B

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 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.
 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.
Active Comparator: 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.
 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.
Active Comparator: 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.
 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
ClinicalTrials.gov Identifier: NCT00860626     History of Changes
Other Study ID Numbers: interferonshorttermnucleoside
Study First Received: March 11, 2009
Last Updated: March 11, 2009
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013